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Trial Comparing Tiotropium Inhalation Capsules vs Placebo in Chronic Obstructive Pulmonary Disease (COPD).

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
tiotropium
Placebo
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

All subjects must have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guideline criteria:

post-bronchodilator Forced Expiratory Volume in one Second/Forced Vital Capacity (FEV1/FVC) ratio < 70% (visit 1).

Subjects must be GOLD Stage II and have a post-bronchodilator FEV1 >50% and < 80% of predicted normal (visit 1). Subjects must be current or ex-smokers with a smoking history of >=10 pack years.

Subjects must have a Medical Research Council (MRC) dyspnea score >= 2.

Exclusion criteria:

Subjects who have been treated with maintenance medications for chronic respiratory disease within six months prior to screening.

Subjects with significant diseases other than COPD. Subjects on chronic systemic corticosteroids.

Subjects with any upper and/or lower respiratory tract infection or COPD exacerbation in the 6 weeks prior to the initial visit 1 or during the screening period prior to visit 3 Subjects with a recent (past 6 months) myocardial infarction, any unstable or life threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year; or who have been hospitalized for cardiac failure during the past year.

Sites / Locations

  • 205.365.1003 Boehringer Ingelheim Investigational Site
  • 205.365.1004 Boehringer Ingelheim Investigational Site
  • 205.365.1098 Boehringer Ingelheim Investigational Site
  • 205.365.1023 Boehringer Ingelheim Investigational Site
  • 205.365.1125 Boehringer Ingelheim Investigational Site
  • 205.365.1024 Boehringer Ingelheim Investigational Site
  • 205.365.1012 Boehringer Ingelheim Investigational Site
  • 205.365.1086 Boehringer Ingelheim Investigational Site
  • 205.365.1006 Boehringer Ingelheim Investigational Site
  • 205.365.1085 Boehringer Ingelheim Investigational Site
  • 205.365.1010 Boehringer Ingelheim Investigational Site
  • 205.365.1007 Boehringer Ingelheim Investigational Site
  • 205.365.1080 Boehringer Ingelheim Investigational Site
  • 205.365.1118 Boehringer Ingelheim Investigational Site
  • 205.365.1033 Boehringer Ingelheim Investigational Site
  • 205.365.1092 Boehringer Ingelheim Investigational Site
  • 205.365.1122 Boehringer Ingelheim Investigational Site
  • 205.365.1103 Boehringer Ingelheim Investigational Site
  • 205.365.1059 Boehringer Ingelheim Investigational Site
  • 205.365.1057 Boehringer Ingelheim Investigational Site
  • 205.365.1058 Boehringer Ingelheim Investigational Site
  • 205.365.1042 Boehringer Ingelheim Investigational Site
  • 205.365.1056 Boehringer Ingelheim Investigational Site
  • 205.365.1104 Boehringer Ingelheim Investigational Site
  • 205.365.1041 Boehringer Ingelheim Investigational Site
  • 205.365.1064 Boehringer Ingelheim Investigational Site
  • 205.365.1107 Boehringer Ingelheim Investigational Site
  • 205.365.1061 Boehringer Ingelheim Investigational Site
  • 205.365.1077 Boehringer Ingelheim Investigational Site
  • 205.365.1079 Boehringer Ingelheim Investigational Site
  • 205.365.1116 Boehringer Ingelheim Investigational Site
  • 205.365.1062 Boehringer Ingelheim Investigational Site
  • 205.365.1083 Boehringer Ingelheim Investigational Site
  • 205.365.1117 Boehringer Ingelheim Investigational Site
  • 205.365.1075 Boehringer Ingelheim Investigational Site
  • 205.365.1063 Boehringer Ingelheim Investigational Site
  • 205.365.1076 Boehringer Ingelheim Investigational Site
  • 205.365.1055 Boehringer Ingelheim Investigational Site
  • 205.365.1066 Boehringer Ingelheim Investigational Site
  • 205.365.1054 Boehringer Ingelheim Investigational Site
  • 205.365.1052 Boehringer Ingelheim Investigational Site
  • 205.365.1050 Boehringer Ingelheim Investigational Site
  • 205.365.1067 Boehringer Ingelheim Investigational Site
  • 205.365.1127 Boehringer Ingelheim Investigational Site
  • 205.365.1126 Boehringer Ingelheim Investigational Site
  • 205.365.1070 Boehringer Ingelheim Investigational Site
  • 205.365.1072 Boehringer Ingelheim Investigational Site
  • 205.365.1071 Boehringer Ingelheim Investigational Site
  • 205.365.1069 Boehringer Ingelheim Investigational Site
  • 205.365.1025 Boehringer Ingelheim Investigational Site
  • 205.365.1020 Boehringer Ingelheim Investigational Site
  • 205.365.1022 Boehringer Ingelheim Investigational Site
  • 205.365.1128 Boehringer Ingelheim Investigational Site
  • 205.365.1110 Boehringer Ingelheim Investigational Site
  • 205.365.1108 Boehringer Ingelheim Investigational Site
  • 205.365.1112 Boehringer Ingelheim Investigational Site
  • 205.365.1114 Boehringer Ingelheim Investigational Site
  • 205.365.1115 Boehringer Ingelheim Investigational Site
  • 205.365.1113 Boehringer Ingelheim Investigational Site
  • 205.365.44002 Boehringer Ingelheim Investigational Site
  • 205.365.44003 Boehringer Ingelheim Investigational Site
  • 205.365.44004 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

placebo

tiotropium

Arm Description

Oral inhalation once daily of placebo matching tiotropium via handihaler

Oral inhalation once daily of 18mcg tiotropium via handihaler

Outcomes

Primary Outcome Measures

Change From Baseline in Lung Function as Measured by the Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0-3h (AUC0-3h)
Change = Week 24 Value - Baseline Value

Secondary Outcome Measures

Trough Forced Expiratory Volume in 1 Second (FEV1)(Baseline)
Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 8)
Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 16)
Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 24)
Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Peak Forced Expiratory Volume in 1 Second (Baseline)
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1.
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 8)
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16)
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24)
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.
Forced Expiratory Volume in 1 Second (Baseline, Pre-dose)
Forced expiratory volume in 1 second (baseline, pre-dose)
Forced Expiratory Volume in 1 Second (Baseline, 30 Minutes)
Forced expiratory volume in 1 second (baseline, 30 minutes)
Forced Expiratory Volume in 1 Second (Baseline, 60 Minutes)
Forced expiratory volume in 1 second (baseline, 60 minutes)
Forced Expiratory Volume in 1 Second (Baseline, 120 Minutes)
Forced expiratory volume in 1 second (baseline, 120 minutes)
Forced Expiratory Volume in 1 Second (Baseline, 180 Minutes)
Forced expiratory volume in 1 second (baseline, 180 minutes)
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, Pre-dose)
Change from baseline in forced expiratory volume in 1 second (at week 8, pre-dose)
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 30 Minutes)
Change from baseline in forced expiratory volume in 1 second (at week 8, 30 minutes)
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 60 Minutes)
Change from baseline in forced expiratory volume in 1 second (at week 8, 60 minutes)
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 120 Minutes)
Change from baseline in forced expiratory volume in 1 second (at week 8, 120 minutes)
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 180 Minutes)
Change from baseline in forced expiratory volume in 1 second (at week 8, 180 minutes)
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 16, Pre-dose)
Change from baseline in forced expiratory volume in 1 second (at week 16, pre-dose)
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 30 Minutes)
Change from baseline in peak forced expiratory volume in 1 second (at week 16, 30 minutes)
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 60 Minutes)
Change from baseline in peak forced expiratory volume in 1 second (at week 16, 60 minutes)
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 120 Minutes)
Change from baseline in peak forced expiratory volume in 1 second (at week 16, 120 minutes)
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 180 Minutes)
Change from baseline in peak forced expiratory volume in 1 second (at week 16, 180 minutes)
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, Pre-dose)
Change from baseline in peak forced expiratory volume in 1 second (at week 24, pre-dose)
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 30 Minutes)
Change from baseline in peak forced expiratory volume in 1 second (at week 24, 30 minutes)
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 60 Minutes)
Change from baseline in peak forced expiratory volume in 1 second (at week 24, 60 minutes)
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 120 Minutes)
Change from baseline in peak forced expiratory volume in 1 second (at week 24, 120 minutes)
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 180 Minutes)
Change from baseline in peak forced expiratory volume in 1 second (at week 24, 180 minutes)
FVC AUC0-3 at Baseline
Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)
FVC AUC0-3 at Week 8 Minus Baseline
Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 8)
FVC AUC0-3 at Week 16 Minus Baseline
Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)(week 16)
FVC AUC0-3 at Week 24 Minus Baseline
Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 24)
Trough Forced Vital Capacity (Baseline)
Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Change From Baseline in Trough Forced Vital Capacity (at Week 8)
Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Change From Baseline in Trough Forced Vital Capacity (at Week 16)
Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Change From Baseline in Trough Forced Vital Capacity (at Week 24)
Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Peak Forced Vital Capacity (FVC) (Baseline)
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1.
Change From Baseline in Peak Forced Vital Capacity (at Week 8)
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.
Change From Baseline in Peak Forced Vital Capacity (at Week 16)
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.
Change From Baseline in Peak Forced Vital Capacity (at Week 24)
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.
Forced Vital Capacity (Baseline, Pre-dose)
Forced vital capacity (baseline, pre-dose)
Forced Vital Capacity (Baseline, 30 Minutes)
Forced vital capacity (baseline, 30 minutes)
Forced Vital Capacity (Baseline, 60 Minutes)
Forced vital capacity (baseline, 60 minutes)
Forced Vital Capacity (Baseline, 120 Minutes)
Forced vital capacity (baseline, 120 minutes)
Forced Vital Capacity (Baseline, 180 Minutes)
Forced vital capacity (baseline, 180 minutes)
Change From Baseline in Forced Vital Capacity (Week 8, Pre-dose)
Change from baseline in forced vital capacity (week 8, pre-dose)
Change From Baseline in Forced Vital Capacity (Week 8, 30 Minutes)
Change from baseline in forced vital capacity (week 8, 30 minutes)
Change From Baseline in Forced Vital Capacity (Week 8, 60 Minutes)
Change from baseline in forced vital capacity (week 8, 60 minutes)
Change From Baseline in Forced Vital Capacity (Week 8, 120 Minutes)
Change from baseline in forced vital capacity (week 8, 120 minutes)
Change From Baseline in Forced Vital Capacity (Week 8, 180 Minutes)
Change from baseline in forced vital capacity (week 8, 180 minutes)
Change From Baseline in Forced Vital Capacity (Week 16, Pre-dose)
Change from baseline in forced vital capacity (week 16, pre-dose)
Change From Baseline in Forced Vital Capacity (Week 16, 30 Minutes)
Change from baseline in forced vital capacity (week 16, 30 minutes)
Change From Baseline in Forced Vital Capacity (Week 16, 60 Minutes)
Change from baseline in forced vital capacity (week 16, 60 minutes)
Change From Baseline in Forced Vital Capacity (Week 16, 120 Minutes)
Change from baseline in forced vital capacity (week 16, 120 minutes)
Change From Baseline in Forced Vital Capacity (Week 16, 180 Minutes)
Change from baseline in forced vital capacity (week 16, 180 minutes)
Change From Baseline in Forced Vital Capacity (Week 24, Pre-dose)
Change from baseline in forced vital capacity (week 24, pre-dose)
Change From Baseline in Forced Vital Capacity (Week 24, 30 Minutes)
Change from baseline in forced vital capacity (week 24, 30 minutes)
Change From Baseline in Forced Vital Capacity (Week 24, 60 Minutes)
Change from baseline in forced vital capacity (week 24, 60 minutes)
Change From Baseline in Forced Vital Capacity (Week 24, 120 Minutes)
Change from baseline in forced vital capacity (week 24, 120 minutes)
Change From Baseline in Forced Vital Capacity (Week 24, 180 Minutes)
Change from baseline in forced vital capacity (week 24, 180 minutes)
Albuterol Use p.r.n. (Baseline)
Number of days that participants used albuterol prn per week
Change From Baseline in Albuterol Use p.r.n. - (Week 4)
Difference in number of days that participants used albuterol prn per week between week 4 and baseline
Change From Baseline in Albuterol Use p.r.n. - (Week 8)
Difference in number of days that participants used albuterol prn per week between week 8 and baseline
Change From Baseline in Albuterol Use p.r.n. -(Week 12)
Difference in number of days that participants used albuterol prn per week between week 12 and baseline
Change From Baseline in Albuterol Use p.r.n. - (Week 16)
Difference in number of days that participants used albuterol prn per week between week 16 and baseline
Change From Baseline in Albuterol Use p.r.n. -(Week 20)
Difference in number of days that participants used albuterol prn per week between week 20 and baseline
Change From Baseline in Albuterol Use p.r.n. - (Week 24)
Difference in number of days that participants used albuterol prn per week between week 24 and baseline
Number of Participants With Categorical Scores on Physician's Global Assessment (Baseline)
The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.
Number of Participants With Categorical Scores on Physician's Global Assessment (Week 12)
The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.
Number of Participants With Categorical Scores on Physician's Global Assessment (Week 24)
The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.
Number of Participants With Categorical Scores on Patient's Global Assessment (Baseline)
The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.
Number of Participants With Categorical Scores on Patient's Global Assessment (Week 12)
The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.
Number of Participants With Categorical Scores on Patient's Global Assessment (Week 24)
The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.
Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Baseline)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 4)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 8)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 12)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 16)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 20)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 24)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.
Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 4)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 8)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 12)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 16)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 20)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 24)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.
Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Baseline)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 4)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 8)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 12)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 16)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 20)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 24)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.
Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Baseline)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 4)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 8)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 12)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 16)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 20)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 24)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.
Physical Activity (Light Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day
Light intensity is less than three metabolic equivalents. Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm.
Change From Baseline in Physical Activity (Light Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day
Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Change From Baseline in Physical Activity (Light Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day
Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Change From Baseline in Physical Activity (Light Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day
Light intensity defined as less than three metabolic equivalents. Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Change From Baseline in Physical Activity (Light Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day
Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Change From Baseline in Physical Activity (Light Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day
Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Change From Baseline in Physical Activity (Light Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day
Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Physical Activity (Moderate or Higher Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day
Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day
Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day
Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day
Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day
Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day
Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day
Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Number of Participants With Healthy Lifestyle (Baseline)
Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no
Number of Participants With Healthy Lifestyle (Week 4)
Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no
Number of Participants With Healthy Lifestyle (Week 8)
Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no
Number of Participants With Healthy Lifestyle (Week 12)
Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no
Number of Participants With Healthy Lifestyle (Week 16)
Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no
Number of Participants With Healthy Lifestyle (Week 20)
Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no
Number of Participants With Healthy Lifestyle (Week 24)
Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no
Active Energy Expenditure (Baseline)
The amount of energy (kcal/day) that a person uses while physically active.
Change From Baseline in Active Energy Expenditure (Week 4)
The amount of energy (kcal/day) that a person uses while physically active.
Change From Baseline in Active Energy Expenditure (Week 8)
The amount of energy (kcal/day) that a person uses while physically active.
Change From Baseline in Active Energy Expenditure (Week 12)
The amount of energy (kcal/day) that a person uses while physically active.
Change From Baseline in Active Energy Expenditure (Week 16)
The amount of energy (kcal/day) that a person uses while physically active.
Change From Baseline in Active Energy Expenditure (Week 20)
The amount of energy (kcal/day) that a person uses while physically active.
Change From Baseline in Active Energy Expenditure (Week 24)
The amount of energy (kcal/day) that a person uses while physically active.
Number of Steps Per Day (Baseline)
Number of steps per day (baseline)
Change From Baseline in Number of Steps Per Day (Week 4)
Change from baseline in number of steps per day (week 4)
Change From Baseline in Number of Steps Per Day(Week 8)
Change from baseline in number of steps per day (week 8)
Change From Baseline in Number of Steps Per Day (Week 12)
Change from baseline in Number of steps per day (week 12)
Change From Baseline in Number of Steps Per Day (Week 16)
Change from baseline in number of steps per day (week 16)
Change From Baseline in Number of Steps Per Day (Week 20)
Change from baseline in number of steps per day (week 20)
Change From Baseline in Number of Steps Per Day (Week 24)
Change from baseline in number of steps per day (week 24)

Full Information

First Posted
July 9, 2007
Last Updated
May 12, 2014
Sponsor
Boehringer Ingelheim
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00523991
Brief Title
Trial Comparing Tiotropium Inhalation Capsules vs Placebo in Chronic Obstructive Pulmonary Disease (COPD).
Official Title
A 24 Week, Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of 18 MCG of Tiotropium Inhalation Capsules Administered by HandiHaler Once-daily Plus PRN Albuterol (Salbutamol) vs. Placebo Plus PRN Albuterol (Salbutamol) in Chronic Obstructive Pulmonary Disease Subjects Naive to Maintenance Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim
Collaborators
Pfizer

4. Oversight

5. Study Description

Brief Summary
A 24 week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 18mcg of tiotropium inhalation capsules administered by Handihaler once daily plus Pro Re Nata (PRN) albuterol (salbutamol) vs. placebo plus PRN albuterol (salbutamol) in chronic obstructive pulmonary disease subjects naive to maintenance therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
457 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Oral inhalation once daily of placebo matching tiotropium via handihaler
Arm Title
tiotropium
Arm Type
Experimental
Arm Description
Oral inhalation once daily of 18mcg tiotropium via handihaler
Intervention Type
Drug
Intervention Name(s)
tiotropium
Intervention Description
Oral inhalation once daily of 18mcg tiotropium via handihaler
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral inhalation once daily of placebo matching tiotropium via handihaler
Primary Outcome Measure Information:
Title
Change From Baseline in Lung Function as Measured by the Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0-3h (AUC0-3h)
Description
Change = Week 24 Value - Baseline Value
Time Frame
baseline, week 24
Secondary Outcome Measure Information:
Title
Trough Forced Expiratory Volume in 1 Second (FEV1)(Baseline)
Description
Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Time Frame
Baseline
Title
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 8)
Description
Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Time Frame
Baseline, week 8
Title
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 16)
Description
Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Time Frame
Baseline, week 16
Title
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 24)
Description
Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Time Frame
Baseline, week 24
Title
Peak Forced Expiratory Volume in 1 Second (Baseline)
Description
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1.
Time Frame
Baseline
Title
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 8)
Description
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.
Time Frame
Baseline, week 8
Title
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16)
Description
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.
Time Frame
Baseline, week 16
Title
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24)
Description
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.
Time Frame
Baseline, week 24
Title
Forced Expiratory Volume in 1 Second (Baseline, Pre-dose)
Description
Forced expiratory volume in 1 second (baseline, pre-dose)
Time Frame
Baseline
Title
Forced Expiratory Volume in 1 Second (Baseline, 30 Minutes)
Description
Forced expiratory volume in 1 second (baseline, 30 minutes)
Time Frame
baseline, 30 minutes
Title
Forced Expiratory Volume in 1 Second (Baseline, 60 Minutes)
Description
Forced expiratory volume in 1 second (baseline, 60 minutes)
Time Frame
baseline, 60 minutes
Title
Forced Expiratory Volume in 1 Second (Baseline, 120 Minutes)
Description
Forced expiratory volume in 1 second (baseline, 120 minutes)
Time Frame
Baseline, 120 minutes
Title
Forced Expiratory Volume in 1 Second (Baseline, 180 Minutes)
Description
Forced expiratory volume in 1 second (baseline, 180 minutes)
Time Frame
Baseline, 180 minutes
Title
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, Pre-dose)
Description
Change from baseline in forced expiratory volume in 1 second (at week 8, pre-dose)
Time Frame
baseline, week 8, pre-dose
Title
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 30 Minutes)
Description
Change from baseline in forced expiratory volume in 1 second (at week 8, 30 minutes)
Time Frame
Baseline, week 8, 30 minutes
Title
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 60 Minutes)
Description
Change from baseline in forced expiratory volume in 1 second (at week 8, 60 minutes)
Time Frame
baseline, week 8, 60 minutes
Title
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 120 Minutes)
Description
Change from baseline in forced expiratory volume in 1 second (at week 8, 120 minutes)
Time Frame
baseline, week 8, 120 minutes
Title
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 180 Minutes)
Description
Change from baseline in forced expiratory volume in 1 second (at week 8, 180 minutes)
Time Frame
baseline, week 8, 180 minutes
Title
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 16, Pre-dose)
Description
Change from baseline in forced expiratory volume in 1 second (at week 16, pre-dose)
Time Frame
baseline, week 16, pre-dose
Title
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 30 Minutes)
Description
Change from baseline in peak forced expiratory volume in 1 second (at week 16, 30 minutes)
Time Frame
Baseline, week 16, 30 minutes
Title
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 60 Minutes)
Description
Change from baseline in peak forced expiratory volume in 1 second (at week 16, 60 minutes)
Time Frame
baseline, week 16, 60 minutes
Title
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 120 Minutes)
Description
Change from baseline in peak forced expiratory volume in 1 second (at week 16, 120 minutes)
Time Frame
baseline, week 16, 120 minutes
Title
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 180 Minutes)
Description
Change from baseline in peak forced expiratory volume in 1 second (at week 16, 180 minutes)
Time Frame
baseline, week 16, 180 minutes
Title
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, Pre-dose)
Description
Change from baseline in peak forced expiratory volume in 1 second (at week 24, pre-dose)
Time Frame
baseline, week 24, pre-dose
Title
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 30 Minutes)
Description
Change from baseline in peak forced expiratory volume in 1 second (at week 24, 30 minutes)
Time Frame
baseline, week 24, 30 minutes
Title
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 60 Minutes)
Description
Change from baseline in peak forced expiratory volume in 1 second (at week 24, 60 minutes)
Time Frame
baseline, week 24, 60 minutes
Title
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 120 Minutes)
Description
Change from baseline in peak forced expiratory volume in 1 second (at week 24, 120 minutes)
Time Frame
baseline, week 24, 120 minutes
Title
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 180 Minutes)
Description
Change from baseline in peak forced expiratory volume in 1 second (at week 24, 180 minutes)
Time Frame
baseline, week 24, 180 minutes
Title
FVC AUC0-3 at Baseline
Description
Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)
Time Frame
baseline
Title
FVC AUC0-3 at Week 8 Minus Baseline
Description
Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 8)
Time Frame
baseline, week 8
Title
FVC AUC0-3 at Week 16 Minus Baseline
Description
Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)(week 16)
Time Frame
baseline, week 16
Title
FVC AUC0-3 at Week 24 Minus Baseline
Description
Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 24)
Time Frame
baseline, week 24
Title
Trough Forced Vital Capacity (Baseline)
Description
Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Time Frame
baseline
Title
Change From Baseline in Trough Forced Vital Capacity (at Week 8)
Description
Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Time Frame
baseline, week 8
Title
Change From Baseline in Trough Forced Vital Capacity (at Week 16)
Description
Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Time Frame
baseline, week 16
Title
Change From Baseline in Trough Forced Vital Capacity (at Week 24)
Description
Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Time Frame
baseline, week 24
Title
Peak Forced Vital Capacity (FVC) (Baseline)
Description
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1.
Time Frame
baseline
Title
Change From Baseline in Peak Forced Vital Capacity (at Week 8)
Description
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.
Time Frame
baseline, week 8
Title
Change From Baseline in Peak Forced Vital Capacity (at Week 16)
Description
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.
Time Frame
baseline, week 16
Title
Change From Baseline in Peak Forced Vital Capacity (at Week 24)
Description
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.
Time Frame
baseline, week 24
Title
Forced Vital Capacity (Baseline, Pre-dose)
Description
Forced vital capacity (baseline, pre-dose)
Time Frame
baseline
Title
Forced Vital Capacity (Baseline, 30 Minutes)
Description
Forced vital capacity (baseline, 30 minutes)
Time Frame
baseline, 30 minutes
Title
Forced Vital Capacity (Baseline, 60 Minutes)
Description
Forced vital capacity (baseline, 60 minutes)
Time Frame
baseline, 60 minutes
Title
Forced Vital Capacity (Baseline, 120 Minutes)
Description
Forced vital capacity (baseline, 120 minutes)
Time Frame
baseline, 120 minutes
Title
Forced Vital Capacity (Baseline, 180 Minutes)
Description
Forced vital capacity (baseline, 180 minutes)
Time Frame
baseline, 180 minutes
Title
Change From Baseline in Forced Vital Capacity (Week 8, Pre-dose)
Description
Change from baseline in forced vital capacity (week 8, pre-dose)
Time Frame
baseline, week 8, pre-dose
Title
Change From Baseline in Forced Vital Capacity (Week 8, 30 Minutes)
Description
Change from baseline in forced vital capacity (week 8, 30 minutes)
Time Frame
baseline, week 8, 30 minutes
Title
Change From Baseline in Forced Vital Capacity (Week 8, 60 Minutes)
Description
Change from baseline in forced vital capacity (week 8, 60 minutes)
Time Frame
baseline, week 8, 60 minutes
Title
Change From Baseline in Forced Vital Capacity (Week 8, 120 Minutes)
Description
Change from baseline in forced vital capacity (week 8, 120 minutes)
Time Frame
baseline, week 8, 120 minutes
Title
Change From Baseline in Forced Vital Capacity (Week 8, 180 Minutes)
Description
Change from baseline in forced vital capacity (week 8, 180 minutes)
Time Frame
baseline, week 8, 180 minutes
Title
Change From Baseline in Forced Vital Capacity (Week 16, Pre-dose)
Description
Change from baseline in forced vital capacity (week 16, pre-dose)
Time Frame
baseline, week 16, pre-dose
Title
Change From Baseline in Forced Vital Capacity (Week 16, 30 Minutes)
Description
Change from baseline in forced vital capacity (week 16, 30 minutes)
Time Frame
baseline, week 16, 30 minutes
Title
Change From Baseline in Forced Vital Capacity (Week 16, 60 Minutes)
Description
Change from baseline in forced vital capacity (week 16, 60 minutes)
Time Frame
baseline, week 16, 60 minutes
Title
Change From Baseline in Forced Vital Capacity (Week 16, 120 Minutes)
Description
Change from baseline in forced vital capacity (week 16, 120 minutes)
Time Frame
baseline, week 16, 120 minutes
Title
Change From Baseline in Forced Vital Capacity (Week 16, 180 Minutes)
Description
Change from baseline in forced vital capacity (week 16, 180 minutes)
Time Frame
baseline, week 16, 180 minutes
Title
Change From Baseline in Forced Vital Capacity (Week 24, Pre-dose)
Description
Change from baseline in forced vital capacity (week 24, pre-dose)
Time Frame
baseline, week 24, pre-dose
Title
Change From Baseline in Forced Vital Capacity (Week 24, 30 Minutes)
Description
Change from baseline in forced vital capacity (week 24, 30 minutes)
Time Frame
baseline, week 24, 30 minutes
Title
Change From Baseline in Forced Vital Capacity (Week 24, 60 Minutes)
Description
Change from baseline in forced vital capacity (week 24, 60 minutes)
Time Frame
baseline, week 24, 60 minutes
Title
Change From Baseline in Forced Vital Capacity (Week 24, 120 Minutes)
Description
Change from baseline in forced vital capacity (week 24, 120 minutes)
Time Frame
baseline, week 24, 120 minutes
Title
Change From Baseline in Forced Vital Capacity (Week 24, 180 Minutes)
Description
Change from baseline in forced vital capacity (week 24, 180 minutes)
Time Frame
baseline, week 24, 180 minutes
Title
Albuterol Use p.r.n. (Baseline)
Description
Number of days that participants used albuterol prn per week
Time Frame
baseline
Title
Change From Baseline in Albuterol Use p.r.n. - (Week 4)
Description
Difference in number of days that participants used albuterol prn per week between week 4 and baseline
Time Frame
baseline, week 4
Title
Change From Baseline in Albuterol Use p.r.n. - (Week 8)
Description
Difference in number of days that participants used albuterol prn per week between week 8 and baseline
Time Frame
baseline, week 8
Title
Change From Baseline in Albuterol Use p.r.n. -(Week 12)
Description
Difference in number of days that participants used albuterol prn per week between week 12 and baseline
Time Frame
baseline, week 12
Title
Change From Baseline in Albuterol Use p.r.n. - (Week 16)
Description
Difference in number of days that participants used albuterol prn per week between week 16 and baseline
Time Frame
baseline, week 16
Title
Change From Baseline in Albuterol Use p.r.n. -(Week 20)
Description
Difference in number of days that participants used albuterol prn per week between week 20 and baseline
Time Frame
baseline, week 20
Title
Change From Baseline in Albuterol Use p.r.n. - (Week 24)
Description
Difference in number of days that participants used albuterol prn per week between week 24 and baseline
Time Frame
baseline, week 24
Title
Number of Participants With Categorical Scores on Physician's Global Assessment (Baseline)
Description
The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.
Time Frame
baseline
Title
Number of Participants With Categorical Scores on Physician's Global Assessment (Week 12)
Description
The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.
Time Frame
week 12
Title
Number of Participants With Categorical Scores on Physician's Global Assessment (Week 24)
Description
The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.
Time Frame
week 24
Title
Number of Participants With Categorical Scores on Patient's Global Assessment (Baseline)
Description
The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.
Time Frame
baseline
Title
Number of Participants With Categorical Scores on Patient's Global Assessment (Week 12)
Description
The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.
Time Frame
week 12
Title
Number of Participants With Categorical Scores on Patient's Global Assessment (Week 24)
Description
The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities. Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.
Time Frame
week 24
Title
Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Baseline)
Description
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.
Time Frame
baseline
Title
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 4)
Description
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.
Time Frame
baseline, week 4
Title
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 8)
Description
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.
Time Frame
baseline, week 8
Title
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 12)
Description
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.
Time Frame
baseline, week 12
Title
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 16)
Description
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.
Time Frame
baseline, week 16
Title
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 20)
Description
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.
Time Frame
baseline, week 20
Title
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 24)
Description
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.
Time Frame
baseline, week 24
Title
Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health
Description
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.
Time Frame
baseline
Title
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 4)
Description
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.
Time Frame
baseline, week 4
Title
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 8)
Description
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.
Time Frame
baseline, week 8
Title
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 12)
Description
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.
Time Frame
baseline, week 12
Title
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 16)
Description
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.
Time Frame
baseline, week 16
Title
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 20)
Description
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.
Time Frame
baseline, week 20
Title
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 24)
Description
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.
Time Frame
baseline, week 24
Title
Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Baseline)
Description
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.
Time Frame
baseline
Title
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 4)
Description
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.
Time Frame
baseline, week 4
Title
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 8)
Description
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.
Time Frame
baseline, week 8
Title
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 12)
Description
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.
Time Frame
baseline, week 12
Title
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 16)
Description
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.
Time Frame
baseline, week 16
Title
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 20)
Description
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.
Time Frame
baseline, week 20
Title
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 24)
Description
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.
Time Frame
baseline, week 24
Title
Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Baseline)
Description
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.
Time Frame
baseline
Title
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 4)
Description
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.
Time Frame
baseline, week 4
Title
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 8)
Description
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.
Time Frame
baseline, week 8
Title
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 12)
Description
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.
Time Frame
baseline, week 12
Title
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 16)
Description
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.
Time Frame
baseline, week 16
Title
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 20)
Description
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.
Time Frame
baseline, week 20
Title
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 24)
Description
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.
Time Frame
baseline, week 24
Title
Physical Activity (Light Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day
Description
Light intensity is less than three metabolic equivalents. Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm.
Time Frame
baseline
Title
Change From Baseline in Physical Activity (Light Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day
Description
Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Time Frame
baseline, week 4
Title
Change From Baseline in Physical Activity (Light Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day
Description
Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Time Frame
baseline, week 8
Title
Change From Baseline in Physical Activity (Light Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day
Description
Light intensity defined as less than three metabolic equivalents. Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Time Frame
baseline, week 12
Title
Change From Baseline in Physical Activity (Light Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day
Description
Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Time Frame
baseline, week 16
Title
Change From Baseline in Physical Activity (Light Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day
Description
Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Time Frame
baseline, week 20
Title
Change From Baseline in Physical Activity (Light Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day
Description
Light intensity is less than three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Time Frame
baseline, week 24
Title
Physical Activity (Moderate or Higher Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day
Description
Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Time Frame
baseline
Title
Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day
Description
Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Time Frame
baseline, week 4
Title
Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day
Description
Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Time Frame
baseline, week 8
Title
Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day
Description
Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Time Frame
baseline, week 12
Title
Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day
Description
Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Time Frame
baseline, week 16
Title
Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day
Description
Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Time Frame
baseline, week 20
Title
Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day
Description
Moderate or higher intensity is greater than or equal to three metabolic equivalents Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate. ln in measure value unit means natural logarithm
Time Frame
baseline, week 24
Title
Number of Participants With Healthy Lifestyle (Baseline)
Description
Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no
Time Frame
baseline
Title
Number of Participants With Healthy Lifestyle (Week 4)
Description
Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no
Time Frame
week 4
Title
Number of Participants With Healthy Lifestyle (Week 8)
Description
Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no
Time Frame
week 8
Title
Number of Participants With Healthy Lifestyle (Week 12)
Description
Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no
Time Frame
week 12
Title
Number of Participants With Healthy Lifestyle (Week 16)
Description
Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no
Time Frame
week 16
Title
Number of Participants With Healthy Lifestyle (Week 20)
Description
Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no
Time Frame
week 20
Title
Number of Participants With Healthy Lifestyle (Week 24)
Description
Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no
Time Frame
week 24
Title
Active Energy Expenditure (Baseline)
Description
The amount of energy (kcal/day) that a person uses while physically active.
Time Frame
baseline
Title
Change From Baseline in Active Energy Expenditure (Week 4)
Description
The amount of energy (kcal/day) that a person uses while physically active.
Time Frame
baseline, week 4
Title
Change From Baseline in Active Energy Expenditure (Week 8)
Description
The amount of energy (kcal/day) that a person uses while physically active.
Time Frame
baseline, week 8
Title
Change From Baseline in Active Energy Expenditure (Week 12)
Description
The amount of energy (kcal/day) that a person uses while physically active.
Time Frame
baseline, week 12
Title
Change From Baseline in Active Energy Expenditure (Week 16)
Description
The amount of energy (kcal/day) that a person uses while physically active.
Time Frame
baseline, week 16
Title
Change From Baseline in Active Energy Expenditure (Week 20)
Description
The amount of energy (kcal/day) that a person uses while physically active.
Time Frame
baseline, week 20
Title
Change From Baseline in Active Energy Expenditure (Week 24)
Description
The amount of energy (kcal/day) that a person uses while physically active.
Time Frame
baseline, week 24
Title
Number of Steps Per Day (Baseline)
Description
Number of steps per day (baseline)
Time Frame
baseline
Title
Change From Baseline in Number of Steps Per Day (Week 4)
Description
Change from baseline in number of steps per day (week 4)
Time Frame
baseline, week 4
Title
Change From Baseline in Number of Steps Per Day(Week 8)
Description
Change from baseline in number of steps per day (week 8)
Time Frame
baseline, week 8
Title
Change From Baseline in Number of Steps Per Day (Week 12)
Description
Change from baseline in Number of steps per day (week 12)
Time Frame
baseline, week 12
Title
Change From Baseline in Number of Steps Per Day (Week 16)
Description
Change from baseline in number of steps per day (week 16)
Time Frame
baseline, week 16
Title
Change From Baseline in Number of Steps Per Day (Week 20)
Description
Change from baseline in number of steps per day (week 20)
Time Frame
baseline, week 20
Title
Change From Baseline in Number of Steps Per Day (Week 24)
Description
Change from baseline in number of steps per day (week 24)
Time Frame
baseline, week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: All subjects must have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guideline criteria: post-bronchodilator Forced Expiratory Volume in one Second/Forced Vital Capacity (FEV1/FVC) ratio < 70% (visit 1). Subjects must be GOLD Stage II and have a post-bronchodilator FEV1 >50% and < 80% of predicted normal (visit 1). Subjects must be current or ex-smokers with a smoking history of >=10 pack years. Subjects must have a Medical Research Council (MRC) dyspnea score >= 2. Exclusion criteria: Subjects who have been treated with maintenance medications for chronic respiratory disease within six months prior to screening. Subjects with significant diseases other than COPD. Subjects on chronic systemic corticosteroids. Subjects with any upper and/or lower respiratory tract infection or COPD exacerbation in the 6 weeks prior to the initial visit 1 or during the screening period prior to visit 3 Subjects with a recent (past 6 months) myocardial infarction, any unstable or life threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year; or who have been hospitalized for cardiac failure during the past year.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
205.365.1003 Boehringer Ingelheim Investigational Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
205.365.1004 Boehringer Ingelheim Investigational Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
205.365.1098 Boehringer Ingelheim Investigational Site
City
Jasper
State/Province
Alabama
Country
United States
Facility Name
205.365.1023 Boehringer Ingelheim Investigational Site
City
Palo Alto
State/Province
California
Country
United States
Facility Name
205.365.1125 Boehringer Ingelheim Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
205.365.1024 Boehringer Ingelheim Investigational Site
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
205.365.1012 Boehringer Ingelheim Investigational Site
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
205.365.1086 Boehringer Ingelheim Investigational Site
City
Bloomington
State/Province
Minnesota
Country
United States
Facility Name
205.365.1006 Boehringer Ingelheim Investigational Site
City
Rochester
State/Province
Minnesota
Country
United States
Facility Name
205.365.1085 Boehringer Ingelheim Investigational Site
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
205.365.1010 Boehringer Ingelheim Investigational Site
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
205.365.1007 Boehringer Ingelheim Investigational Site
City
Rochester
State/Province
New York
Country
United States
Facility Name
205.365.1080 Boehringer Ingelheim Investigational Site
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
205.365.1118 Boehringer Ingelheim Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
205.365.1033 Boehringer Ingelheim Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
205.365.1092 Boehringer Ingelheim Investigational Site
City
Kingsport
State/Province
Tennessee
Country
United States
Facility Name
205.365.1122 Boehringer Ingelheim Investigational Site
City
Clarksburg
State/Province
West Virginia
Country
United States
Facility Name
205.365.1103 Boehringer Ingelheim Investigational Site
City
Gilly
Country
Belgium
Facility Name
205.365.1059 Boehringer Ingelheim Investigational Site
City
Leuven
Country
Belgium
Facility Name
205.365.1057 Boehringer Ingelheim Investigational Site
City
Menen
Country
Belgium
Facility Name
205.365.1058 Boehringer Ingelheim Investigational Site
City
Yvoir
Country
Belgium
Facility Name
205.365.1042 Boehringer Ingelheim Investigational Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
205.365.1056 Boehringer Ingelheim Investigational Site
City
Kingston
State/Province
Ontario
Country
Canada
Facility Name
205.365.1104 Boehringer Ingelheim Investigational Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
205.365.1041 Boehringer Ingelheim Investigational Site
City
Ste-Foy
State/Province
Quebec
Country
Canada
Facility Name
205.365.1064 Boehringer Ingelheim Investigational Site
City
Cvikov
Country
Czech Republic
Facility Name
205.365.1107 Boehringer Ingelheim Investigational Site
City
Hradec Kralove
Country
Czech Republic
Facility Name
205.365.1061 Boehringer Ingelheim Investigational Site
City
Karlovy Vary
Country
Czech Republic
Facility Name
205.365.1077 Boehringer Ingelheim Investigational Site
City
Liberec
Country
Czech Republic
Facility Name
205.365.1079 Boehringer Ingelheim Investigational Site
City
Neratovice
Country
Czech Republic
Facility Name
205.365.1116 Boehringer Ingelheim Investigational Site
City
Pardubice
Country
Czech Republic
Facility Name
205.365.1062 Boehringer Ingelheim Investigational Site
City
Praha 10
Country
Czech Republic
Facility Name
205.365.1083 Boehringer Ingelheim Investigational Site
City
Praha 3
Country
Czech Republic
Facility Name
205.365.1117 Boehringer Ingelheim Investigational Site
City
Praha 6
Country
Czech Republic
Facility Name
205.365.1075 Boehringer Ingelheim Investigational Site
City
Strakonice
Country
Czech Republic
Facility Name
205.365.1063 Boehringer Ingelheim Investigational Site
City
Tabor
Country
Czech Republic
Facility Name
205.365.1076 Boehringer Ingelheim Investigational Site
City
Usti nad Labem
Country
Czech Republic
Facility Name
205.365.1055 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
205.365.1066 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
205.365.1054 Boehringer Ingelheim Investigational Site
City
Gelnhausen
Country
Germany
Facility Name
205.365.1052 Boehringer Ingelheim Investigational Site
City
Rüdersdorf
Country
Germany
Facility Name
205.365.1050 Boehringer Ingelheim Investigational Site
City
Ulm
Country
Germany
Facility Name
205.365.1067 Boehringer Ingelheim Investigational Site
City
Athens
Country
Greece
Facility Name
205.365.1127 Boehringer Ingelheim Investigational Site
City
Athens
Country
Greece
Facility Name
205.365.1126 Boehringer Ingelheim Investigational Site
City
Thessaloniki
Country
Greece
Facility Name
205.365.1070 Boehringer Ingelheim Investigational Site
City
Enschede
Country
Netherlands
Facility Name
205.365.1072 Boehringer Ingelheim Investigational Site
City
Etten Leur
Country
Netherlands
Facility Name
205.365.1071 Boehringer Ingelheim Investigational Site
City
Spijkenisse
Country
Netherlands
Facility Name
205.365.1069 Boehringer Ingelheim Investigational Site
City
Zutphen
Country
Netherlands
Facility Name
205.365.1025 Boehringer Ingelheim Investigational Site
City
Amadora
Country
Portugal
Facility Name
205.365.1020 Boehringer Ingelheim Investigational Site
City
Coimbra
Country
Portugal
Facility Name
205.365.1022 Boehringer Ingelheim Investigational Site
City
Lisboa
Country
Portugal
Facility Name
205.365.1128 Boehringer Ingelheim Investigational Site
City
Dnipropetrovsk
Country
Ukraine
Facility Name
205.365.1110 Boehringer Ingelheim Investigational Site
City
Kharkiv
Country
Ukraine
Facility Name
205.365.1108 Boehringer Ingelheim Investigational Site
City
Kharkov
Country
Ukraine
Facility Name
205.365.1112 Boehringer Ingelheim Investigational Site
City
Kharkov
Country
Ukraine
Facility Name
205.365.1114 Boehringer Ingelheim Investigational Site
City
Kiev
Country
Ukraine
Facility Name
205.365.1115 Boehringer Ingelheim Investigational Site
City
Kiev
Country
Ukraine
Facility Name
205.365.1113 Boehringer Ingelheim Investigational Site
City
Simferopol
Country
Ukraine
Facility Name
205.365.44002 Boehringer Ingelheim Investigational Site
City
Garston, Watford
Country
United Kingdom
Facility Name
205.365.44003 Boehringer Ingelheim Investigational Site
City
Harrow
Country
United Kingdom
Facility Name
205.365.44004 Boehringer Ingelheim Investigational Site
City
Warminster
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24841833
Citation
Troosters T, Sciurba FC, Decramer M, Siafakas NM, Klioze SS, Sutradhar SC, Weisman IM, Yunis C. Tiotropium in patients with moderate COPD naive to maintenance therapy: a randomised placebo-controlled trial. NPJ Prim Care Respir Med. 2014 May 20;24:14003. doi: 10.1038/npjpcrm.2014.3.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.365_U11-3062.pdf
Description
Related Info

Learn more about this trial

Trial Comparing Tiotropium Inhalation Capsules vs Placebo in Chronic Obstructive Pulmonary Disease (COPD).

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