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An Efficacy and Safety Study to Compare Three Doses of BEA 2180 BR to Tiotropium and Placebo in the Respimat Inhaler.

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

BEA 2180 BR

Tiotropium Bromide

Placebo

About this trial

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

Eligibility Criteria

40 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions.
All patients must have a diagnosis of chronic obstructive pulmonary disease (P95 4381) and must meet the following spirometric criteria:
Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 (post-bronchodilator, 30 minutes post salbutamol/albuterol) <80% of predicted normal and FEV1 less than or equal to 70% of FVC at the PFTs at Visit 1 (screening).
Male or female patients 40 years of age or older.
Patients must be current or ex-smokers with a smoking history of more than 10 pack years. Patients who have never smoked cigarettes must be excluded.
Patients must be able to perform technically acceptable pulmonary function tests and electronic PEFR measurements, and must be able to maintain records (Patient Daily Diary) during the study period as required in the protocol.
Patients must be able to inhale medication in a competent manner from the Respimat® inhaler (Appendix I)

Exclusion Criteria:

Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient ability to participate in the study.
Patients with clinically relevant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a significant disease as defined in exclusion criterion No. 1.
Patients with a recent history (one year or less) of myocardial infarction.
Patients with any unstable or life-threatening cardiac arrhythmia.
Patients who have been hospitalized for heart failure within the past 3 years.
Patients with a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed.
Patients with known symptomatic prostatic hyperplasia or bladder neck obstruction as defined in exclusion criteria No. 1.
Patients with known narrow-angle glaucoma.
Patients with asthma or a history of asthma.
Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis.
Patients with known active tuberculosis.
Patients with a history of and/or active significant alcohol or drug abuse. See exclusion criterion No. 1.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

BEA 2180 BR low dose

BEA 2180 BR medium dose

BEA 2180 BR high dose

Tiotropium Bromide

Arm Description

Matching Placebo

Low dose

Medium dose

High dose

Tiotropium Bromide

Outcomes

Primary Outcome Measures

Trough Forced Expiratory Volume in One Second (FEV1) Response After 24 Weeks

Trough Forced expiratory volume in one second (FEV1) response was defined as the change from baseline in trough FEV1. Trough FEV1 was defined as the mean of the two FEV1 measurements recorded at the pre-dose measurements (40 and 15 minutes before the drug administration) at the end of the dosing interval (24 hours post previous drug administration from the Respimat® Inhaler). Baseline FEV1 was pre-treatment FEV1 values measured at Day 1 of treatment period (baseline) prior to administration of the first dose of study medication, which was the mean of the measurements recorded from the pulmonary function tests taken at 40 and 15 minutes prior to drug administration at Day 1 of treatment period.

Secondary Outcome Measures

Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks

Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks

Trough forced vital capacity (FVC) response was defined as the change from baseline in trough FVC. Trough FVC was defined as the mean of the two FVC measurements recorded at the pre-dose measurements (40 and 15 minutes before drug administration) at the end of the dosing interval (24 hours post previous drug administration from the Respimat® Inhaler), which were obtained through spirometry at the same time points as for forced expiratory volume in one second. Baseline FVC was the mean of the two measurements of FVC taken at 40 and 15 minutes before drug administration at Day 1 of treatment period.

Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks

Forced expiratory volume in one second (FEV1) area under the curve from 0 to 3 hours (AUC0-3h) response after 0, 4, 12 and 24 weeks are reported. The FEV1 AUC0-3h response is the area under the curve from 0 to 3 hours post drug administration for change from baseline values of FEV1. The area under the curve (AUC) is calculated as the area under the curve from 0 to 3 hours at weeks 0, 4, 12 and 24 using the trapezoidal rule and using planned time, divided by the full duration (3 hours) to report in litres. The mean of the pre-dose values (at 40 minutes and 15 minutes before dosing) are used with a time value of zero for calculating the AUC values starting at zero. The baseline FEV1 is the mean of the two measurements taken at 40 and 15 minutes before drug administration at Day 1 of treatment period.

Forced Vital Capacity (FVC) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks

Forced vital capacity (FVC) area under the curve from 0 to 3 hours (AUC0-3h) response after 0, 4, 12 and 24 weeks are reported. The FVC AUC0-3h response is the area under the curve from 0 to 3 hours post drug administration for change from baseline values of FVC. The area under the curve (AUC) is calculated as the area under the curve from 0 to 3 hours at weeks 0, 4, 12 and 24 using the trapezoidal rule and using planned time, divided by the full duration (3 hours) to report in litres. The mean of the pre-dose values (at 40 minutes and 15 minutes before dosing) are used with a time value of zero for calculating the AUC values starting at zero. The baseline FVC is the mean of the two measurements taken at 40 and 15 minutes before drug administration at Day 1 of treatment period.

Forced Expiratory Volume in One Second (FEV1) Peak Response After 0, 4, 12, and 24 Weeks

Forced expiratory volume in one second (FEV1) peak response after 0, 4, 12, and 24 weeks were reported. Peak FEV1 response was the maximum change from baseline for the post-dose measurements of FEV1. Baseline FEV1 is the mean of the two measurements taken at 40 and 15 minutes before drug administration.

Forced Vital Capacity (FVC) Peak Response After 0, 4, 12, and 24 Weeks

Forced Vital Capacity (FVC) peak response after 0, 4, 12, and 24 weeks were reported. Peak FVC response was the maximum change from baseline for the post-dose measurements of FVC. Baseline FVC is the mean of the two measurements taken at 40 and 15 minutes before drug administration.

Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point

Individual Forced expiratory volume in one second (FEV1) values measured at each time points at Week 0, 4, 12, and 24 were reported.

Individual Forced Vital Capacity (FVC) Measurements at Each Time Point

Individual Forced Vital Capacity (FVC) values measured at each time point at Week 0, 4, 12, and 24 were reported.

Trough Forced Expiratory Volume in One Second (FEV1) Response on Day 3 and 5

Trough Forced expiratory volume in one second (FEV1) response on Day 3 and 5 are reported, for which the FEV1 response is the change from baseline in trough FEV1. Trough FEV1 for respective day (Day 3 or Day 5)was defined as the mean of the two FEV1 measurements recorded at the pre-dose measurements (40 and 15 minutes before the drug administration) at the end of the dosing interval (24 hours post previous drug administration from the Respimat® Inhaler) at that day. Baseline FEV1 was pre-treatment FEV1 values measured at Day 1 of treatment period (baseline) prior to administration of the first dose of study medication, which was the mean of the measurements recorded from the pulmonary function tests taken at 40 and 15 minutes prior to drug administration at Day 1 of treatment period.

Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration

Forced expiratory volume in one second (FEV1) values at 3 minutes and 10 minutes following drug administration at Week 0, 4, 12, and 24 are reported.

Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration

Forced Vital Capacity (FVC) values at 3 minutes and 10 minutes following drug administration at Week 0, 4, 12, and 24 are reported.

Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR)

The patient recorded twice daily peak flow measurements with an electronic peak flow meter throughout the entire evaluation period. Morning measurements were performed immediately upon arising after the patient had cleared out mucus, prior to administration of trial and/or rescue medication. The evening measurements were performed at bedtime. The weekly mean morning peak expiratory flow rate (PEFR) is reported.

Weekly Mean Evening Peak Expiratory Flow Rate (PEFR)

The patient recorded twice daily peak flow measurements with an electronic peak flow meter throughout the entire evaluation period. Morning measurements were performed immediately upon arising after the patient had cleared out mucus, prior to administration of trial and/or rescue medication. The evening measurements were performed at bedtime. The weekly mean of evening peak expiratory flow rate (PEFR) is reported.

Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol])

The patient recorded the number of occasions salbutamol (albuterol) Metered Dose Inhaler (MDI) was used each day and night during the entire evaluation period. The weekly mean number of occasions of rescue therapy used per day (PRN salbutamol [albuterol]) is reported.

Physician's Global Evaluation

Physicians make a global evaluation reflecting the physician's global opinion of the overall clinical condition of the patient as "poor" (score 1 or 2), "fair" (score 3 or 4), "good" (score 5 or 6), or "excellent" (score 7 or 8). These assessments are made prior to pulmonary function testing and are summarized on pulmonary function test days. This evaluation was based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, and other relevant clinical observations. The score ranges from 1 to 8 with higher score indicating better overall clinical condition.

Transition Dyspnea Index - Functional Impairment Domain Score

The transitional dyspnea index (TDI) evaluates the patient's condition related to breathlessness. The TDI includes three domains: functional impairment, magnitude of task, and magnitude of effort. The TDI domain score of functional impairment is reported, which domain score ranges from -3 (major deterioration in the ability of working and doing activities due to shortness of breath; the worst score) to 3 (major improvement in the ability of working and doing activities; mild restriction on full activities due to the improvement of shortness of breath; the best score).

Transition Dyspnea Index - Magnitude of Task Domain Score

Transition Dyspnea Index - Magnitude of Effort Domain Score

The transitional dyspnea index (TDI) evaluates the patient's condition related to breathlessness. The TDI includes three domains: functional impairment, magnitude of task, and magnitude of effort. The TDI domain score of magnitude of effort is reported, which sub-score ranges from -3 (severe decrease in effort from baseline to avoid shortness of breath. Activities now take 50-100% longer to complete than required at baseline; the worst score) to 3 (Able to do things with much greater effort than previously with few pauses. Activities may be performed 50- 100% more rapidly than at baseline; the best score).

St. George's Respiratory Questionnaire (SGRQ) Total Score

The St. George's Respiratory Questionnaire (SGRQ) is a well-established, self-completed tool measuring health-related quality of life in patients with diseases of airways obstruction on three aspects of symptoms, activity, and impacts. The total SGRQ score is reported, which ranges from 0 (the best score) to 100 (the worst score) with smaller score value indicating less limitations due to breathlessness and better quality of life.

36-item-health Survey (SF-36) 8 Domain Scores at Baseline

The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function (10 questions), role physical (4 questions), Bodily pain (2 questions), General physical health (5 questions), Vitality (4 questions), Social functioning (2 questions), role emotional (3 questions), and General mental health (5 questions). Each domain score is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the score value, the better the health condition.

36-item-health Survey (SF-36) - Physical Function Domain Score

The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health. The domain score of physical function (based on 10 questions) is reported, which is the weighted sum of the questions in corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the better the physical function.

36-item-health Survey (SF-36) - Role Physical Domain Score

The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health. The domain score of role limitations due to physical health problems (based on 4 questions) is reported, which is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the less limitations in roles due to physical health problems.

36-item-health Survey (SF-36) - Bodily Pain Domain Score

The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health. The domain score of bodily pain (based on 2 questions) is reported, which is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the less severer the bodily pain.

36-item-health Survey (SF-36) - General Physical Health Domain Score

The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health. The domain score of general physical health (based on 5 questions) is reported, which is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the better the physical health in general.

36-item-health Survey (SF-36) - Vitality Domain Score

The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health. The domain score of vitality (based on 4 questions) is reported, which is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the more vitality and less fatigue one has.

36-item-health Survey (SF-36) - Social Functioning Domain Score

The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health. The domain score of Social functioning (based on 2 questions) is reported, which is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the better the social functioning.

36-item-health Survey (SF-36) - Role Emotional Domain Score

The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health. The domain score of role emotional (based on 4 questions) is reported, which is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the less limitation in roles due to emotional problems.

36-item-health Survey (SF-36) - General Mental Health Domain Score

The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health. The domain score of general mental health (based on 5 questions) is reported, which is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the better the mental health in general.

Number of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

Number of patients with at least one Chronic Obstructive Pulmonary Disease (COPD) exacerbation is reported. Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation is reported. A Chronic Obstructive Pulmonary Disease (COPD) exacerbation is defined as "a complex of lower respiratory events / symptoms (increase or new onset) related to the underlying COPD, with a duration of three days or more, requiring a change in treatment", where a "complex of lower respiratory events / symptoms" means at least two of the following: Shortness of breath, Sputum production (volume), Occurrence of purulent sputum, Cough, Wheezing, Chest tightness.

Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation is reported. A Chronic Obstructive Pulmonary Disease (COPD) exacerbation is defined as "a complex of lower respiratory events / symptoms (increase or new onset) related to the underlying COPD, with a duration of three days or more, requiring a change in treatment", where a "complex of lower respiratory events / symptoms" means at least two of the following: Shortness of breath, Sputum production (volume), Occurrence of purulent sputum, Cough, Wheezing, Chest tightness.

Full Information

NCT ID

NCT00528996

First Posted

September 12, 2007

Last Updated

July 30, 2021

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT00528996

Brief Title

An Efficacy and Safety Study to Compare Three Doses of BEA 2180 BR to Tiotropium and Placebo in the Respimat Inhaler.

Official Title

A Multinational, Randomised, Double-blind, Placebo- and Active-controlled, Parallel Group Efficacy and Safety Comparison Over 24 Weeks of Three Doses (50µg, 100µg, 200µg) of BEA 2180 BR to Tiotropium 5µg, Delivered by the Respimat Inhaler and Placebo in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

September 6, 2007 (Actual)

Primary Completion Date

May 5, 2009 (Actual)

Study Completion Date

May 5, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary

The primary objective of this study is to compare the bronchodilator efficacy of three doses (50 µg, 100 µg and 200 µg) of BEA 2180 delivered by the Respimat® once daily to placebo and tiotropium bromide delivered by the Respimat® in patients with COPD. Additional objectives include comparing the effects on dyspnea and health status.

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 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

2080 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Matching Placebo

Arm Title

BEA 2180 BR low dose

Arm Type

Experimental

Arm Description

Low dose

Arm Title

BEA 2180 BR medium dose

Arm Type

Experimental

Arm Description

Medium dose

Arm Title

BEA 2180 BR high dose

Arm Type

Experimental

Arm Description

High dose

Arm Title

Tiotropium Bromide

Arm Type

Experimental

Arm Description

Tiotropium Bromide

Intervention Type

Drug

Intervention Name(s)

BEA 2180 BR

Intervention Description

Solution

Intervention Type

Drug

Intervention Name(s)

Tiotropium Bromide

Intervention Description

Solution

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Solution

Primary Outcome Measure Information:

Title

Trough Forced Expiratory Volume in One Second (FEV1) Response After 24 Weeks

Description

Time Frame

40 minutes (min) and 15 min before drug administration at baseline (Day 1 of treatment period) and Week 24.

Secondary Outcome Measure Information:

Title

Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks

Description

Time Frame

40 minutes (min) and 15 min before drug administration at baseline (Day 1 of treatment period) and Week 1, 2, 4, 8, 12 and 18.

Title

Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks

Description

Time Frame

40 minutes (min) and 15 min before drug administration at baseline (Day 1 of treatment period) and Week 1, 2, 4, 8, 12, 18, and 24.

Title

Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks

Description

Time Frame

40 minutes (min) and 15 min before drug administration and 15 min, 30 min, 60 min, 2 hours, 3 hours after drug administration at Week 0 (Day 1 of treatment period), 4, 12, 24.

Title

Forced Vital Capacity (FVC) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks

Description

Time Frame

40 minutes (min) and 15 min before drug administration and 15 min, 30 min, 60 min, 2 hours, 3 hours after drug administration at Week 0 (Day 1 of treatment period), 4, 12, 24.

Title

Forced Expiratory Volume in One Second (FEV1) Peak Response After 0, 4, 12, and 24 Weeks

Description

Time Frame

40 minutes (min) and 15 min before drug administration and 15 min, 30 min, 60 min, 2 hours, 3 hours after drug administration at Week 0 (Day 1 of treatment period), 4, 12, 24.

Title

Forced Vital Capacity (FVC) Peak Response After 0, 4, 12, and 24 Weeks

Description

Time Frame

40 minutes (min) and 15 min before drug administration and 15 min, 30 min, 60 min, 2 hours, 3 hours after drug administration at Week 0 (Day 1 of treatment period), 4, 12, 24.

Title

Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point

Description

Individual Forced expiratory volume in one second (FEV1) values measured at each time points at Week 0, 4, 12, and 24 were reported.

Time Frame

15 minutes (min), 30 min, 1 hour (h), 2 h, 3 h after drug administration at Week 0 (Day 1 of treatment period), 4, 12, and 24. At 0 min (at drug administration) at Week 4, 12, and 24.

Title

Individual Forced Vital Capacity (FVC) Measurements at Each Time Point

Description

Individual Forced Vital Capacity (FVC) values measured at each time point at Week 0, 4, 12, and 24 were reported.

Time Frame

15 minutes (min), 30 min, 1 hour (h), 2 h, 3 h after drug administration at Week 0 (Day 1 of treatment period), 4, 12, and 24. At 0 min (at drug administration) at Week 4, 12, and 24.

Title

Trough Forced Expiratory Volume in One Second (FEV1) Response on Day 3 and 5

Description

Time Frame

40 minutes (min) and 15 min before drug administration at Day 1 (baseline) and Day 3 and 5 of treatment period.

Title

Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration

Description

Forced expiratory volume in one second (FEV1) values at 3 minutes and 10 minutes following drug administration at Week 0, 4, 12, and 24 are reported.

Time Frame

3 minutes (min) and 10 after drug administration at Week 0 (Day 1 of treatment period), 4, 12, and 24.

Title

Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration

Description

Forced Vital Capacity (FVC) values at 3 minutes and 10 minutes following drug administration at Week 0, 4, 12, and 24 are reported.

Time Frame

3 minutes (min) and 10 min after drug administration at Week 0 (Day 1 of treatment period), 4, 12, and 24.

Title

Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR)

Description

Time Frame

Assessed before drug administration per day during 24 weeks with weekly mean values reporting.

Title

Weekly Mean Evening Peak Expiratory Flow Rate (PEFR)

Description

The patient recorded twice daily peak flow measurements with an electronic peak flow meter throughout the entire evaluation period. Morning measurements were performed immediately upon arising after the patient had cleared out mucus, prior to administration of trial and/or rescue medication. The evening measurements were performed at bedtime. The weekly mean of evening peak expiratory flow rate (PEFR) is reported.

Time Frame

Assessed at bed time per day during 24 weeks with weekly mean values reporting.

Title

Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol])

Description

Time Frame

Assessed once per day during 24 weeks with weekly mean values reporting.

Title

Physician's Global Evaluation

Description

Time Frame

At Week 0, 4, 12, and 24.

Title

Transition Dyspnea Index - Functional Impairment Domain Score

Description

Time Frame

At Week 0 (baseline), 4, 12 and 24.

Title

Transition Dyspnea Index - Magnitude of Task Domain Score

Description

Time Frame

At week 0 (baseline), 4, 12 and 24

Title

Transition Dyspnea Index - Magnitude of Effort Domain Score

Description

The transitional dyspnea index (TDI) evaluates the patient's condition related to breathlessness. The TDI includes three domains: functional impairment, magnitude of task, and magnitude of effort. The TDI domain score of magnitude of effort is reported, which sub-score ranges from -3 (severe decrease in effort from baseline to avoid shortness of breath. Activities now take 50-100% longer to complete than required at baseline; the worst score) to 3 (Able to do things with much greater effort than previously with few pauses. Activities may be performed 50- 100% more rapidly than at baseline; the best score).

Time Frame

At Week 0 (baseline), 4, 12 and 24

Title

St. George's Respiratory Questionnaire (SGRQ) Total Score

Description

Time Frame

At Week 0, 4, 12, and 24.

Title

36-item-health Survey (SF-36) 8 Domain Scores at Baseline

Description

Time Frame

At baseline (Week 0, Day 1 of treatment period).

Title

36-item-health Survey (SF-36) - Physical Function Domain Score

Description

The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health. The domain score of physical function (based on 10 questions) is reported, which is the weighted sum of the questions in corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the better the physical function.

Time Frame

At Week 4, 12, and 24.

Title

36-item-health Survey (SF-36) - Role Physical Domain Score

Description

The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health. The domain score of role limitations due to physical health problems (based on 4 questions) is reported, which is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the less limitations in roles due to physical health problems.

Time Frame

At Week 4, 12, and 24.

Title

36-item-health Survey (SF-36) - Bodily Pain Domain Score

Description

The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health. The domain score of bodily pain (based on 2 questions) is reported, which is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the less severer the bodily pain.

Time Frame

At Week 4, 12, and 24.

Title

36-item-health Survey (SF-36) - General Physical Health Domain Score

Description

The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health. The domain score of general physical health (based on 5 questions) is reported, which is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the better the physical health in general.

Time Frame

At Week 4, 12, and 24.

Title

36-item-health Survey (SF-36) - Vitality Domain Score

Description

The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health. The domain score of vitality (based on 4 questions) is reported, which is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the more vitality and less fatigue one has.

Time Frame

At Week 4, 12, and 24.

Title

36-item-health Survey (SF-36) - Social Functioning Domain Score

Description

The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health. The domain score of Social functioning (based on 2 questions) is reported, which is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the better the social functioning.

Time Frame

At Week 4, 12, and 24.

Title

36-item-health Survey (SF-36) - Role Emotional Domain Score

Description

The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health. The domain score of role emotional (based on 4 questions) is reported, which is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the less limitation in roles due to emotional problems.

Time Frame

At Week 4, 12, and 24.

Title

36-item-health Survey (SF-36) - General Mental Health Domain Score

Description

The 36-item-health Survey (SF-36) is a multi-purpose, short-form health survey with 36 questions evaluating patient's physical and mental health. Among the 36 questions, 1 is on the health comparing to 1 year ago and the remaining 35 questions are divided into 8 domains: Physical function, role limitations physical, Bodily pain, General physical health, Vitality, Social functioning, role limitations emotional, and General mental health. The domain score of general mental health (based on 5 questions) is reported, which is the weighted sum of the questions in the corresponding domain with the domain score ranging from 0 to 100. The higher the domain score, the better the mental health in general.

Time Frame

At Week 4, 12, and 24.

Title

Number of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

Description

Time Frame

From first does until 30 days after the end of treatment, up to 205 days.

Title

Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

Description

Time Frame

From first does until 30 days after the end of treatment, up to 205 days.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions. All patients must have a diagnosis of chronic obstructive pulmonary disease (P95 4381) and must meet the following spirometric criteria: Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 (post-bronchodilator, 30 minutes post salbutamol/albuterol) <80% of predicted normal and FEV1 less than or equal to 70% of FVC at the PFTs at Visit 1 (screening). Male or female patients 40 years of age or older. Patients must be current or ex-smokers with a smoking history of more than 10 pack years. Patients who have never smoked cigarettes must be excluded. Patients must be able to perform technically acceptable pulmonary function tests and electronic PEFR measurements, and must be able to maintain records (Patient Daily Diary) during the study period as required in the protocol. Patients must be able to inhale medication in a competent manner from the Respimat® inhaler (Appendix I) Exclusion Criteria: Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient ability to participate in the study. Patients with clinically relevant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a significant disease as defined in exclusion criterion No. 1. Patients with a recent history (one year or less) of myocardial infarction. Patients with any unstable or life-threatening cardiac arrhythmia. Patients who have been hospitalized for heart failure within the past 3 years. Patients with a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed. Patients with known symptomatic prostatic hyperplasia or bladder neck obstruction as defined in exclusion criteria No. 1. Patients with known narrow-angle glaucoma. Patients with asthma or a history of asthma. Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis. Patients with known active tuberculosis. Patients with a history of and/or active significant alcohol or drug abuse. See exclusion criterion No. 1.

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

1205.14.061 Boehringer Ingelheim Investigational Site

City

Jasper

State/Province

Alabama

Country

United States

Facility Name

1205.14.054 Boehringer Ingelheim Investigational Site

City

Mobile

State/Province

Alabama

Country

United States

Facility Name

1205.14.042 Boehringer Ingelheim Investigational Site

City

Berkeley

State/Province

California

Country

United States

Facility Name

1205.14.017 Boehringer Ingelheim Investigational Site

City

La Jolla

State/Province

California

Country

United States

Facility Name

1205.14.022 Boehringer Ingelheim Investigational Site

City

Lakewood

State/Province

California

Country

United States

Facility Name

1205.14.046 Boehringer Ingelheim Investigational Site

City

Riverside

State/Province

California

Country

United States

Facility Name

1205.14.008 Boehringer Ingelheim Investigational Site

City

San Diego

State/Province

California

Country

United States

Facility Name

1205.14.047 Boehringer Ingelheim Investigational Site

City

San Diego

State/Province

California

Country

United States

Facility Name

1205.14.037 Boehringer Ingelheim Investigational Site

City

Sepulveda

State/Province

California

Country

United States

Facility Name

1205.14.041 Boehringer Ingelheim Investigational Site

City

Denver

State/Province

Colorado

Country

United States

Facility Name

1205.14.027 Boehringer Ingelheim Investigational Site

City

Fort Collins

State/Province

Colorado

Country

United States

Facility Name

1205.14.034 Boehringer Ingelheim Investigational Site

City

Wheat Ridge

State/Province

Colorado

Country

United States

Facility Name

1205.14.050 Boehringer Ingelheim Investigational Site

City

Stamford

State/Province

Connecticut

Country

United States

Facility Name

1205.14.013 Boehringer Ingelheim Investigational Site

City

Bay Pines

State/Province

Florida

Country

United States

Facility Name

1205.14.016 Boehringer Ingelheim Investigational Site

City

Clearwater

State/Province

Florida

Country

United States

Facility Name

1205.14.048 Boehringer Ingelheim Investigational Site

City

DeLand

State/Province

Florida

Country

United States

Facility Name

1205.14.043 Boehringer Ingelheim Investigational Site

City

Panama City

State/Province

Florida

Country

United States

Facility Name

1205.14.040 Boehringer Ingelheim Investigational Site

City

Tampa

State/Province

Florida

Country

United States

Facility Name

1205.14.007 Boehringer Ingelheim Investigational Site

City

Atlanta

State/Province

Georgia

Country

United States

Facility Name

1205.14.053 Boehringer Ingelheim Investigational Site

City

Stockbridge

State/Province

Georgia

Country

United States

Facility Name

1205.14.014 Boehringer Ingelheim Investigational Site

City

Coeur d'Alene

State/Province

Idaho

Country

United States

Facility Name

1205.14.035 Boehringer Ingelheim Investigational Site

City

Olathe

State/Province

Kansas

Country

United States

Facility Name

1205.14.057 Boehringer Ingelheim Investigational Site

City

New Orleans

State/Province

Louisiana

Country

United States

Facility Name

1205.14.052 Boehringer Ingelheim Investigational Site

City

Shreveport

State/Province

Louisiana

Country

United States

Facility Name

1205.14.036 Boehringer Ingelheim Investigational Site

City

Ann Arbor

State/Province

Michigan

Country

United States

Facility Name

1205.14.019 Boehringer Ingelheim Investigational Site

City

Livonia

State/Province

Michigan

Country

United States

Facility Name

1205.14.018 Boehringer Ingelheim Investigational Site

City

Chesterfield

State/Province

Missouri

Country

United States

Facility Name

1205.14.032 Boehringer Ingelheim Investigational Site

City

Saint Louis

State/Province

Missouri

Country

United States

Facility Name

1205.14.033 Boehringer Ingelheim Investigational Site

City

Reno

State/Province

Nevada

Country

United States

Facility Name

1205.14.044 Boehringer Ingelheim Investigational Site

City

Brick

State/Province

New Jersey

Country

United States

Facility Name

1205.14.056 Boehringer Ingelheim Investigational Site

City

Cherry Hill

State/Province

New Jersey

Country

United States

Facility Name

1205.14.058 Boehringer Ingelheim Investigational Site

City

Summit

State/Province

New Jersey

Country

United States

Facility Name

1205.14.010 Boehringer Ingelheim Investigational Site

City

Albuquerque

State/Province

New Mexico

Country

United States

Facility Name

1205.14.062 Boehringer Ingelheim Investigational Site

City

Larchmont

State/Province

New York

Country

United States

Facility Name

1205.14.028 Boehringer Ingelheim Investigational Site

City

Mineola

State/Province

New York

Country

United States

Facility Name

1205.14.030 Boehringer Ingelheim Investigational Site

City

New Hyde Park

State/Province

New York

Country

United States

Facility Name

1205.14.021 Boehringer Ingelheim Investigational Site

City

New York

State/Province

New York

Country

United States

Facility Name

1205.14.059 Boehringer Ingelheim Investigational Site

City

Toledo

State/Province

Ohio

Country

United States

Facility Name

1205.14.012 Boehringer Ingelheim Investigational Site

City

Oklahoma City

State/Province

Oklahoma

Country

United States

Facility Name

1205.14.031 Boehringer Ingelheim Investigational Site

City

Medford

State/Province

Oregon

Country

United States

Facility Name

1205.14.003 Boehringer Ingelheim Investigational Site

City

Philadelphia

State/Province

Pennsylvania

Country

United States

Facility Name

1205.14.004 Boehringer Ingelheim Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

Country

United States

Facility Name

1205.14.005 Boehringer Ingelheim Investigational Site

City

Johnston

State/Province

Rhode Island

Country

United States

Facility Name

1205.14.029 Boehringer Ingelheim Investigational Site

City

Charleston

State/Province

South Carolina

Country

United States

Facility Name

1205.14.055 Boehringer Ingelheim Investigational Site

City

Greer

State/Province

South Carolina

Country

United States

Facility Name

1205.14.020 Boehringer Ingelheim Investigational Site

City

Spartanburg

State/Province

South Carolina

Country

United States

Facility Name

1205.14.045 Boehringer Ingelheim Investigational Site

City

Fort Worth

State/Province

Texas

Country

United States

Facility Name

1205.14.025 Boehringer Ingelheim Investigational Site

City

Houston

State/Province

Texas

Country

United States

Facility Name

1205.14.060 Boehringer Ingelheim Investigational Site

City

Killeen

State/Province

Texas

Country

United States

Facility Name

1205.14.002 Boehringer Ingelheim Investigational Site

City

San Antonio

State/Province

Texas

Country

United States

Facility Name

1205.14.023 Boehringer Ingelheim Investigational Site

City

Richmond

State/Province

Virginia

Country

United States

Facility Name

1205.14.024 Boehringer Ingelheim Investigational Site

City

Richmond

State/Province

Virginia

Country

United States

Facility Name

1205.14.026 Boehringer Ingelheim Investigational Site

City

Roanoke

State/Province

Virginia

Country

United States

Facility Name

1205.14.009 Boehringer Ingelheim Investigational Site

City

Spokane

State/Province

Washington

Country

United States

Facility Name

1205.14.039 Boehringer Ingelheim Investigational Site

City

Spokane

State/Province

Washington

Country

United States

Facility Name

1205.14.001 Boehringer Ingelheim Investigational Site

City

Morgantown

State/Province

West Virginia

Country

United States

Facility Name

1205.14.151 Boehringer Ingelheim Investigational Site

City

Edmonton

State/Province

Alberta

Country

Canada

Facility Name

1205.14.144 Boehringer Ingelheim Investigational Site

City

Vancouver

State/Province

British Columbia

Country

Canada

Facility Name

1205.14.148 Boehringer Ingelheim Investigational Site

City

St. John's

State/Province

Newfoundland and Labrador

Country

Canada

Facility Name

1205.14.143 Boehringer Ingelheim Investigational Site

City

Burlington

State/Province

Ontario

Country

Canada

Facility Name

1205.14.142 Boehringer Ingelheim Investigational Site

City

Downsview

State/Province

Ontario

Country

Canada

Facility Name

1205.14.150 Boehringer Ingelheim Investigational Site

City

Grimsby

State/Province

Ontario

Country

Canada

Facility Name

1205.14.149 Boehringer Ingelheim Investigational Site

City

Mississauga

State/Province

Ontario

Country

Canada

Facility Name

1205.14.145 Boehringer Ingelheim Investigational Site

City

Sherbrooke

State/Province

Quebec

Country

Canada

Facility Name

1205.14.146 Boehringer Ingelheim Investigational Site

City

Quebec

Country

Canada

Facility Name

1205.14.381 Boehringer Ingelheim Investigational Site

City

Aschaffenburg

Country

Germany

Facility Name

1205.14.164 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

1205.14.167 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

1205.14.168 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

1205.14.172 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

1205.14.175 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

1205.14.177 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

1205.14.178 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

1205.14.377 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

1205.14.382 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

1205.14.387 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

1205.14.388 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

1205.14.165 Boehringer Ingelheim Investigational Site

City

Bonn

Country

Germany

Facility Name

1205.14.176 Boehringer Ingelheim Investigational Site

City

Cottbus

Country

Germany

Facility Name

1205.14.171 Boehringer Ingelheim Investigational Site

City

Dortmund

Country

Germany

Facility Name

1205.14.379 Boehringer Ingelheim Investigational Site

City

Geesthacht

Country

Germany

Facility Name

1205.14.174 Boehringer Ingelheim Investigational Site

City

Gelnhausen

Country

Germany

Facility Name

1205.14.173 Boehringer Ingelheim Investigational Site

City

Hamburg

Country

Germany

Facility Name

1205.14.375 Boehringer Ingelheim Investigational Site

City

Hannover

Country

Germany

Facility Name

1205.14.378 Boehringer Ingelheim Investigational Site

City

Koblenz

Country

Germany

Facility Name

1205.14.170 Boehringer Ingelheim Investigational Site

City

Lübeck

Country

Germany

Facility Name

1205.14.162 Boehringer Ingelheim Investigational Site

City

Mainz

Country

Germany

Facility Name

1205.14.384 Boehringer Ingelheim Investigational Site

City

Marburg

Country

Germany

Facility Name

1205.14.166 Boehringer Ingelheim Investigational Site

City

Minden

Country

Germany

Facility Name

1205.14.372 Boehringer Ingelheim Investigational Site

City

Neumünster

Country

Germany

Facility Name

1205.14.386 Boehringer Ingelheim Investigational Site

City

Neuruppin

Country

Germany

Facility Name

1205.14.385 Boehringer Ingelheim Investigational Site

City

Oschersleben

Country

Germany

Facility Name

1205.14.169 Boehringer Ingelheim Investigational Site

City

Rüdersdorf

Country

Germany

Facility Name

1205.14.179 Boehringer Ingelheim Investigational Site

City

Rüsselsheim

Country

Germany

Facility Name

1205.14.376 Boehringer Ingelheim Investigational Site

City

Saarbrücken

Country

Germany

Facility Name

1205.14.374 Boehringer Ingelheim Investigational Site

City

Schwetzingen

Country

Germany

Facility Name

1205.14.371 Boehringer Ingelheim Investigational Site

City

Witten

Country

Germany

Facility Name

1205.14.373 Boehringer Ingelheim Investigational Site

City

Witten

Country

Germany

Facility Name

1205.14.279 Boehringer Ingelheim Investigational Site

City

Budakeszi

Country

Hungary

Facility Name

1205.14.273 Boehringer Ingelheim Investigational Site

City

Budapest

Country

Hungary

Facility Name

1205.14.283 Boehringer Ingelheim Investigational Site

City

Budapest

Country

Hungary

Facility Name

1205.14.287 Boehringer Ingelheim Investigational Site

City

Budapest

Country

Hungary

Facility Name

1205.14.286 Boehringer Ingelheim Investigational Site

City

Cegled

Country

Hungary

Facility Name

1205.14.281 Boehringer Ingelheim Investigational Site

City

Debrecen

Country

Hungary

Facility Name

1205.14.272 Boehringer Ingelheim Investigational Site

City

Deszk

Country

Hungary

Facility Name

1205.14.289 Boehringer Ingelheim Investigational Site

City

Deszk

Country

Hungary

Facility Name

1205.14.271 Boehringer Ingelheim Investigational Site

City

Erd

Country

Hungary

Facility Name

1205.14.282 Boehringer Ingelheim Investigational Site

City

Gyula

Country

Hungary

Facility Name

1205.14.276 Boehringer Ingelheim Investigational Site

City

Gödöllö

Country

Hungary

Facility Name

1205.14.277 Boehringer Ingelheim Investigational Site

City

Komarom

Country

Hungary

Facility Name

1205.14.278 Boehringer Ingelheim Investigational Site

City

Matrahaza

Country

Hungary

Facility Name

1205.14.280 Boehringer Ingelheim Investigational Site

City

Mosonmagyarovar

Country

Hungary

Facility Name

1205.14.285 Boehringer Ingelheim Investigational Site

City

Sopron

Country

Hungary

Facility Name

1205.14.275 Boehringer Ingelheim Investigational Site

City

Szarvas

Country

Hungary

Facility Name

1205.14.288 Boehringer Ingelheim Investigational Site

City

Szazhalombatta

Country

Hungary

Facility Name

1205.14.284 Boehringer Ingelheim Investigational Site

City

Tatabanya

Country

Hungary

Facility Name

1205.14.274 Boehringer Ingelheim Investigational Site

City

Zalaegerszeg

Country

Hungary

Facility Name

1205.14.225 Boehringer Ingelheim Investigational Site

City

Gyeonggi-do

Country

Korea, Republic of

Facility Name

1205.14.228 Boehringer Ingelheim Investigational Site

City

Gyeonggi-do

Country

Korea, Republic of

Facility Name

1205.14.227 Boehringer Ingelheim Investigational Site

City

Seongdong-gu

Country

Korea, Republic of

Facility Name

1205.14.221 Boehringer Ingelheim Investigational Site

City

Seoul

Country

Korea, Republic of

Facility Name

1205.14.222 Boehringer Ingelheim Investigational Site

City

Seoul

Country

Korea, Republic of

Facility Name

1205.14.223 Boehringer Ingelheim Investigational Site

City

Seoul

Country

Korea, Republic of

Facility Name

1205.14.224 Boehringer Ingelheim Investigational Site

City

Seoul

Country

Korea, Republic of

Facility Name

1205.14.226 Boehringer Ingelheim Investigational Site

City

Seoul

Country

Korea, Republic of

Facility Name

1205.14.117 Boehringer Ingelheim Investigational Site

City

Ciudad de Mexico

Country

Mexico

Facility Name

1205.14.108 Boehringer Ingelheim Investigational Site

City

Cuernavaca, Mor. México

Country

Mexico

Facility Name

1205.14.101 Boehringer Ingelheim Investigational Site

City

Hermosillo, Sonora

Country

Mexico

Facility Name

1205.14.119 Boehringer Ingelheim Investigational Site

City

Metepec

Country

Mexico

Facility Name

1205.14.120 Boehringer Ingelheim Investigational Site

City

Mexico City

Country

Mexico

Facility Name

1205.14.116 Boehringer Ingelheim Investigational Site

City

Monterrey, Nuevo León

Country

Mexico

Facility Name

1205.14.102 Boehringer Ingelheim Investigational Site

City

Monterrey

Country

Mexico

Facility Name

1205.14.105 Boehringer Ingelheim Investigational Site

City

Zapopan, Jal.

Country

Mexico

Facility Name

1205.14.251 Boehringer Ingelheim Investigational Site

City

Chrzanow

Country

Poland

Facility Name

1205.14.253 Boehringer Ingelheim Investigational Site

City

Gdansk

Country

Poland

Facility Name

1205.14.254 Boehringer Ingelheim Investigational Site

City

Gdansk

Country

Poland

Facility Name

1205.14.246 Boehringer Ingelheim Investigational Site

City

Krakow

Country

Poland

Facility Name

1205.14.241 Boehringer Ingelheim Investigational Site

City

Lodz

Country

Poland

Facility Name

1205.14.242 Boehringer Ingelheim Investigational Site

City

Lodz

Country

Poland

Facility Name

1205.14.255 Boehringer Ingelheim Investigational Site

City

Miechow

Country

Poland

Facility Name

1205.14.248 Boehringer Ingelheim Investigational Site

City

Ruda Slaska

Country

Poland

Facility Name

1205.14.249 Boehringer Ingelheim Investigational Site

City

Tarnowskie Gory

Country

Poland

Facility Name

1205.14.252 Boehringer Ingelheim Investigational Site

City

Wilkowice

Country

Poland

Facility Name

1205.14.243 Boehringer Ingelheim Investigational Site

City

Wroclaw

Country

Poland

Facility Name

1205.14.244 Boehringer Ingelheim Investigational Site

City

Wroclaw

Country

Poland

Facility Name

1205.14.245 Boehringer Ingelheim Investigational Site

City

Wroclaw

Country

Poland

Facility Name

1205.14.247 Boehringer Ingelheim Investigational Site

City

Zabrze

Country

Poland

Facility Name

1205.14.301 Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

1205.14.302 Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

1205.14.303 Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

1205.14.304 Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

1205.14.305 Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

1205.14.306 Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

1205.14.310 Boehringer Ingelheim Investigational Site

City

St. Petersburg

Country

Russian Federation

Facility Name

1205.14.311 Boehringer Ingelheim Investigational Site

City

St. Petersburg

Country

Russian Federation

Facility Name

1205.14.312 Boehringer Ingelheim Investigational Site

City

St. Petersburg

Country

Russian Federation

Facility Name

1205.14.313 Boehringer Ingelheim Investigational Site

City

St. Petersburg

Country

Russian Federation

Facility Name

1205.14.314 Boehringer Ingelheim Investigational Site

City

St. Petersburg

Country

Russian Federation

Facility Name

1205.14.307 Boehringer Ingelheim Investigational Site

City

Yaroslavl

Country

Russian Federation

Facility Name

1205.14.308 Boehringer Ingelheim Investigational Site

City

Yaroslavl

Country

Russian Federation

Facility Name

1205.14.309 Boehringer Ingelheim Investigational Site

City

Yaroslavl

Country

Russian Federation

Facility Name

1205.14.182 Boehringer Ingelheim Investigational Site

City

Badajoz

Country

Spain

Facility Name

1205.14.186 Boehringer Ingelheim Investigational Site

City

Cáceres

Country

Spain

Facility Name

1205.14.183 Boehringer Ingelheim Investigational Site

City

Madrid

Country

Spain

Facility Name

1205.14.191 Boehringer Ingelheim Investigational Site

City

Málaga

Country

Spain

Facility Name

1205.14.181 Boehringer Ingelheim Investigational Site

City

Terrassa (Barcelona)

Country

Spain

Facility Name

1205.14.190 Boehringer Ingelheim Investigational Site

City

Torrevieja

Country

Spain

Facility Name

1205.14.189 Boehringer Ingelheim Investigational Site

City

Valencia

Country

Spain

Facility Name

1205.14.187 Boehringer Ingelheim Investigational Site

City

Vigo

Country

Spain

Facility Name

1205.14.207 Boehringer Ingelheim Investigational Site

City

Changhua

Country

Taiwan

Facility Name

1205.14.208 Boehringer Ingelheim Investigational Site

City

Chiayi City

Country

Taiwan

Facility Name

1205.14.209 Boehringer Ingelheim Investigational Site

City

Kaohsiung County

Country

Taiwan

Facility Name

1205.14.210 Boehringer Ingelheim Investigational Site

City

Kaohsiung

Country

Taiwan

Facility Name

1205.14.205 Boehringer Ingelheim Investigational Site

City

Taichung

Country

Taiwan

Facility Name

1205.14.206 Boehringer Ingelheim Investigational Site

City

Taichung

Country

Taiwan

Facility Name

1205.14.202 Boehringer Ingelheim Investigational Site

City

Taipei

Country

Taiwan

Facility Name

1205.14.204 Boehringer Ingelheim Investigational Site

City

Taipei

Country

Taiwan

Facility Name

1205.14.201 Boehringer Ingelheim Investigational Site

City

Taoyuan County

Country

Taiwan

12. IPD Sharing Statement

Citations:

PubMed Identifier

23490224

Citation

Abrahams R, Moroni-Zentgraf P, Ramsdell J, Schmidt H, Joseph E, Karpel J. Safety and efficacy of the once-daily anticholinergic BEA2180 compared with tiotropium in patients with COPD. Respir Med. 2013 Jun;107(6):854-62. doi: 10.1016/j.rmed.2013.02.005. Epub 2013 Mar 13.

Results Reference

derived

Links:

URL

http://www.mystudywindow.com/

Description

Related Info

Learn more about this trial

An Efficacy and Safety Study to Compare Three Doses of BEA 2180 BR to Tiotropium and Placebo in the Respimat Inhaler.

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An Efficacy and Safety Study to Compare Three Doses of BEA 2180 BR to Tiotropium and Placebo in the Respimat Inhaler.

Pulmonary Disease, Chronic Obstructive

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial