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Efficacy and Safety of Tiotropium and Salmeterol in Moderate Persistent Asthma Patients Homozygous for B16-Arg/Arg

Primary Purpose

Asthma

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Tiotropium bromide

Placebo

Salmeterol xinafoate

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion_Criteria: Patients homozygous for arginine at the 16th amino acid position of the beta2 adrenergic receptor (B16 Arg/Arg) All patients must sign and date an Informed Consent Form for the study prior to participation in the trial Male or female outpatients with at least 18 years of age, but not older than 65 years Patients must have a documented history of asthma Patients must be current non-smokers or ex-smokers with a cigarette smoking history of <10 pack-years Patients must be on a maintenance treatment with inhaled corticosteroids with a total daily dose of 400 - 1000 mcg budesonide or equivalent Exclusion_Criteria: Patients with a significant disease other than asthma Patients with a recent history (i.e., six months or less) of myocardial infarction Patients who have been hospitalized for heart failure (New York Heart Association class III or IV) within the past year Patients with any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year Patients with 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 a diagnosis of chronic obstructive pulmonary disease (COPD) 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 who have undergone thoracotomy with pulmonary resection. Patients who have completed a pulmonary rehabilitation program in the six weeks prior to visit 1 or patients who are currently in a pulmonary rehabilitation program that will not be maintained throughout the duration of the study.

Outcomes

Primary Outcome Measures

Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial

Change from baseline in mean weekly morning peak expiratory flow at 16 weeks. Baseline is defined as the last week prior to the randomisation visit

Secondary Outcome Measures

Mean Weekly Morning Peak Expiratory Flow at Week 4

Mean weekly morning peak expiratory flow at week 4, pre-dose

Mean Weekly Morning Peak Expiratory Flow at Week 8

Mean weekly morning peak expiratory flow at week 8, pre-dose

Mean Weekly Morning Peak Expiratory Flow at Week 12

Mean weekly morning peak expiratory flow at week 12, pre-dose

Mean Weekly Morning Peak Expiratory Flow at Week 16

Mean weekly morning peak expiratory flow at week 16, pre-dose

Mean Weekly Evening Peak Expiratory Flow at Week 4

Mean weekly evening peak expiratory flow at week 4, pre-dose

Mean Weekly Evening Peak Expiratory Flow at Week 8

Mean weekly evening peak expiratory flow at week 8, pre-dose

Mean Weekly Evening Peak Expiratory Flow at Week 12

Mean weekly evening peak expiratory flow at week 12, pre-dose

Mean Weekly Evening Peak Expiratory Flow at Week 16

Mean weekly evening peak expiratory flow at week 16, pre-dose

Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 4

Mean weekly morning forced expiratory volume in 1 second at week 4, pre-dose

Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 8

Mean weekly morning forced expiratory volume in 1 second at week 8, pre-dose

Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 12

Mean weekly morning forced expiratory volume in 1 second at week 12, pre-dose

Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 16

Mean weekly morning forced expiratory volume in 1 second at week 16, pre-dose

Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 4

Mean weekly evening forced expiratory volume in 1 second at week 4, pre-dose

Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 8

Mean weekly evening forced expiratory volume in 1 second at week 8, pre-dose

Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 12

Mean weekly evening forced expiratory volume in 1 second at week 12, pre-dose

Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 16

Mean weekly evening forced expiratory volume in 1 second at week 16, pre-dose

Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 4

Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value

Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 8

Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value

Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 12

Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value

Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 16

Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value

Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms in the Morning" at Week 4

Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value

Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 8

Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value

Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 12

Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value

Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 16

Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value

Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 4

Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value

Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 8

Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value

Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 12

Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value

Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 16

Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value

Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 4

Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value

Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 8

Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value

Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 12

Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value

Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 16

Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value

Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 4

Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value

Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 8

Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value

Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 12

Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value

Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 16

Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value

Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 4

Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value

Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 8

Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value

Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 12

Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value

Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 16

Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value

Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 3

Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 6 weeks of treatment

Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 4

Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 12 weeks of treatment

Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 5

Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 16 weeks od treatment

Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 3

Morning pre-dose forced vital capacity as measured by spirometry after 6 weeks of treatment

Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 4

Morning pre-dose forced vital capacity as measured by spirometry after 12 weeks of treatment

Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 5

Morning pre-dose forced vital capacity as measured by spirometry after 16 weeks of treatment

Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) Overall Score at Visit 3

Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value

Mini-AQLQ Overall Score at Visit 4

Mini-AQLQ Overall Score at Visit 5

Systolic Blood Pressure in Conjunction With Spirometry at Visit 3

Systolic blood pressure collected in conjunction with spirometry at 6 weeks

Systolic Blood Pressure in Conjunction With Spirometry at Visit 4

Systolic blood pressure collected in conjunction with spirometry at 12 weeks

Systolic Blood Pressure in Conjunction With Spirometry at Visit 5

Systolic blood pressure collected in conjunction with spirometry at 16 weeks

Diastolic Blood Pressure in Conjunction With Spirometry at Visit 3

Diastolic blood pressure collected in conjunction with spirometry at 6 weeks

Diastolic Blood Pressure in Conjunction With Spirometry at Visit 4

Diastolic blood pressure collected in conjunction with spirometry at 12 weeks

Diastolic Blood Pressure in Conjunction With Spirometry at Visit 5

Diastolic blood pressure collected in conjunction with spirometry at 16 weeks

Pulse Rate in Conjunction With Spirometry at Visit 3

Pulse rate collected in conjunction with spirometry at 6 weeks

Pulse Rate in Conjunction With Spirometry at Visit 4

Pulse rate collected in conjunction with spirometry at 12 weeks

Pulse Rate in Conjunction With Spirometry at Visit 5

Pulse rate collected in conjunction with spirometry at 16 weeks

Mean PEF Variability at Week 4

PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%

Mean PEF Variability at Week 8

Mean PEF Variability at Week 12

Mean PEF Variability at Week 16

Full Information

NCT ID

NCT00350207

First Posted

July 7, 2006

Last Updated

November 27, 2013

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT00350207

Brief Title

Efficacy and Safety of Tiotropium and Salmeterol in Moderate Persistent Asthma Patients Homozygous for B16-Arg/Arg

Official Title

A 16-week Randomised, Placebo-controlled, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler (2 Actuations of 2.5 Mcg Once Daily) With That of Salmeterol From the Hydrofluoroalkane Metered Dose Inhaler (2 Actuations of 25 Mcg Twice Daily) in Moderate Persistent Asthma Patients With the B16-Arg/Arg Genotype

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Completed

Study Start Date

July 2006 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary

This is a 16 week multicentre, multinational, randomised, double-blind, double-dummy, placebo-controlled, parallel group study to evaluate the long-term efficacy and safety of tiotropium compared to salmeterol in moderate persistent asthmatic (GINA step 3) patients homozygous for arginine at the 16th amino acid position of the beta-adrenergic receptor (ADRB2). Following an initial 4-week run-in period on salmeterol MDI patients will be randomised into the 16 week double-blind treatment period in which they receive either tiotropium once daily administered from the Respimat inhaler or salmeterol twice daily administered from the hydrofluoro-alkane Metered Dose Inhaler (MDI), or placebo twice daily. After the 16 week treatment period all patients will receive salmeterol MDI twice daily for four weeks. The patients perform daily morning and evening peak flow (PEF) and Forced Expiratory Volume in the First Second (FEV1) measurements with an electronic peak flow meter throughout the study. Daily data on asthma control and use of rescue medication are recorded using an electronic diary included in the electronic peak flow meter. On study visits the Mini-Asthma Quality of Life Questionnaire (Elizabeth Juniper) is administered, pulse and blood pressure and pre-dose pulmonary function testing (FEV1 and Forced Vital Capacity) are performed.

6. Conditions and Keywords

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

Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Enrollment

388 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Tiotropium bromide

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Type

Drug

Intervention Name(s)

Salmeterol xinafoate

Primary Outcome Measure Information:

Title

Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial

Description

Change from baseline in mean weekly morning peak expiratory flow at 16 weeks. Baseline is defined as the last week prior to the randomisation visit

Time Frame

baseline and after 16 weeks of treatment

Secondary Outcome Measure Information:

Title

Mean Weekly Morning Peak Expiratory Flow at Week 4

Description

Mean weekly morning peak expiratory flow at week 4, pre-dose

Time Frame

After 4 weeks of treatment

Title

Mean Weekly Morning Peak Expiratory Flow at Week 8

Description

Mean weekly morning peak expiratory flow at week 8, pre-dose

Time Frame

After 8 weeks of treatment

Title

Mean Weekly Morning Peak Expiratory Flow at Week 12

Description

Mean weekly morning peak expiratory flow at week 12, pre-dose

Time Frame

After 12 weeks of treatment

Title

Mean Weekly Morning Peak Expiratory Flow at Week 16

Description

Mean weekly morning peak expiratory flow at week 16, pre-dose

Time Frame

After 16 weeks of treatment

Title

Mean Weekly Evening Peak Expiratory Flow at Week 4

Description

Mean weekly evening peak expiratory flow at week 4, pre-dose

Time Frame

After 4 weeks of treatment

Title

Mean Weekly Evening Peak Expiratory Flow at Week 8

Description

Mean weekly evening peak expiratory flow at week 8, pre-dose

Time Frame

After 8 weeks of treatment

Title

Mean Weekly Evening Peak Expiratory Flow at Week 12

Description

Mean weekly evening peak expiratory flow at week 12, pre-dose

Time Frame

After 12 weeks of treatment

Title

Mean Weekly Evening Peak Expiratory Flow at Week 16

Description

Mean weekly evening peak expiratory flow at week 16, pre-dose

Time Frame

After 16 weeks of treatment

Title

Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 4

Description

Mean weekly morning forced expiratory volume in 1 second at week 4, pre-dose

Time Frame

After 4 weeks of treatment

Title

Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 8

Description

Mean weekly morning forced expiratory volume in 1 second at week 8, pre-dose

Time Frame

After 8 weeks of treatment

Title

Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 12

Description

Mean weekly morning forced expiratory volume in 1 second at week 12, pre-dose

Time Frame

After 12 weeks of treatment

Title

Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 16

Description

Mean weekly morning forced expiratory volume in 1 second at week 16, pre-dose

Time Frame

After 16 weeks of treatment

Title

Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 4

Description

Mean weekly evening forced expiratory volume in 1 second at week 4, pre-dose

Time Frame

After 4 weeks of treatment

Title

Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 8

Description

Mean weekly evening forced expiratory volume in 1 second at week 8, pre-dose

Time Frame

After 8 weeks of treatment

Title

Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 12

Description

Mean weekly evening forced expiratory volume in 1 second at week 12, pre-dose

Time Frame

After 12 weeks of treatment

Title

Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 16

Description

Mean weekly evening forced expiratory volume in 1 second at week 16, pre-dose

Time Frame

After 16 weeks of treatment

Title

Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 4

Description

Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value

Time Frame

After 4 weeks of treatment

Title

Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 8

Description

Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value

Time Frame

After 8 weeks of treatment

Title

Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 12

Description

Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value

Time Frame

After 12 weeks of treatment

Title

Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 16

Description

Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value

Time Frame

After 16 weeks of treatment

Title

Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms in the Morning" at Week 4

Description

Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value

Time Frame

After 4 weeks of treatment

Title

Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 8

Description

Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value

Time Frame

After 8 weeks of treatment

Title

Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 12

Description

Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value

Time Frame

After 12 weeks of treatment

Title

Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 16

Description

Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value

Time Frame

After 16 weeks of treatment

Title

Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 4

Description

Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value

Time Frame

After 4 weeks of treatment

Title

Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 8

Description

Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value

Time Frame

After 8 weeks of treatment

Title

Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 12

Description

Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value

Time Frame

After 12 weeks of treatment

Title

Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 16

Description

Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value

Time Frame

After 16 weeks of treatment

Title

Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 4

Description

Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value

Time Frame

After 4 weeks of treatment

Title

Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 8

Description

Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value

Time Frame

After 8 weeks of treatment

Title

Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 12

Description

Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value

Time Frame

After 12 weeks of treatment

Title

Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 16

Description

Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value

Time Frame

After 16 weeks of treatment

Title

Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 4

Description

Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value

Time Frame

After 4 weeks of treatment

Title

Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 8

Description

Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value

Time Frame

After 8 weeks of treatment

Title

Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 12

Description

Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value

Time Frame

After 12 weeks of treatment

Title

Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 16

Description

Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value

Time Frame

After 16 weeks of treatment

Title

Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 4

Description

Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value

Time Frame

After 4 weeks of treatment

Title

Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 8

Description

Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value

Time Frame

After 8 weeks of treatment

Title

Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 12

Description

Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value

Time Frame

After 12 weeks of treatment

Title

Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 16

Description

Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value

Time Frame

After 16 weeks of treatment

Title

Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 3

Description

Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 6 weeks of treatment

Time Frame

After 6 weeks of treatment

Title

Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 4

Description

Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 12 weeks of treatment

Time Frame

After 12 weeks of treatment

Title

Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 5

Description

Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 16 weeks od treatment

Time Frame

After 16 weeks of treatment

Title

Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 3

Description

Morning pre-dose forced vital capacity as measured by spirometry after 6 weeks of treatment

Time Frame

After 6 weeks of treatment

Title

Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 4

Description

Morning pre-dose forced vital capacity as measured by spirometry after 12 weeks of treatment

Time Frame

After 12 weeks of treatment

Title

Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 5

Description

Morning pre-dose forced vital capacity as measured by spirometry after 16 weeks of treatment

Time Frame

After 16 weeks of treatment

Title

Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) Overall Score at Visit 3

Description

Time Frame

After 6 weeks of treatment

Title

Mini-AQLQ Overall Score at Visit 4

Description

Time Frame

After 12 weeks of treatment

Title

Mini-AQLQ Overall Score at Visit 5

Description

Time Frame

After 16 weeks of treatment

Title

Systolic Blood Pressure in Conjunction With Spirometry at Visit 3

Description

Systolic blood pressure collected in conjunction with spirometry at 6 weeks

Time Frame

After 6 weeks of treatment

Title

Systolic Blood Pressure in Conjunction With Spirometry at Visit 4

Description

Systolic blood pressure collected in conjunction with spirometry at 12 weeks

Time Frame

After 12 weeks of treatment

Title

Systolic Blood Pressure in Conjunction With Spirometry at Visit 5

Description

Systolic blood pressure collected in conjunction with spirometry at 16 weeks

Time Frame

After 16 weeks of treatment

Title

Diastolic Blood Pressure in Conjunction With Spirometry at Visit 3

Description

Diastolic blood pressure collected in conjunction with spirometry at 6 weeks

Time Frame

After 6 weeks of treatment

Title

Diastolic Blood Pressure in Conjunction With Spirometry at Visit 4

Description

Diastolic blood pressure collected in conjunction with spirometry at 12 weeks

Time Frame

After 12 weeks of treatment

Title

Diastolic Blood Pressure in Conjunction With Spirometry at Visit 5

Description

Diastolic blood pressure collected in conjunction with spirometry at 16 weeks

Time Frame

After 16 weeks of treatment

Title

Pulse Rate in Conjunction With Spirometry at Visit 3

Description

Pulse rate collected in conjunction with spirometry at 6 weeks

Time Frame

After 6 weeks of treatment

Title

Pulse Rate in Conjunction With Spirometry at Visit 4

Description

Pulse rate collected in conjunction with spirometry at 12 weeks

Time Frame

After 12 weeks of treatment

Title

Pulse Rate in Conjunction With Spirometry at Visit 5

Description

Pulse rate collected in conjunction with spirometry at 16 weeks

Time Frame

After 16 weeks of treatment

Title

Mean PEF Variability at Week 4

Description

Time Frame

After 4 weeks of treatment

Title

Mean PEF Variability at Week 8

Description

Time Frame

After 8 weeks of treatment

Title

Mean PEF Variability at Week 12

Description

Time Frame

After 12 weeks of treatment

Title

Mean PEF Variability at Week 16

Description

Time Frame

After 16 weeks of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

205.342.43002 Boehringer Ingelheim Investigational Site

City

Graz

Country

Austria

Facility Name

205.342.43004 Boehringer Ingelheim Investigational Site

City

Trofaiach

Country

Austria

Facility Name

205.342.43003 Boehringer Ingelheim Investigational Site

City

Wels

Country

Austria

Facility Name

205.342.43001 Boehringer Ingelheim Investigational Site

City

Wien

Country

Austria

Facility Name

205.342.43005 Boehringer Ingelheim Investigational Site

City

Wien

Country

Austria

Facility Name

205.342.43006 Boehringer Ingelheim Investigational Site

City

Wien

Country

Austria

Facility Name

205.342.43007 Boehringer Ingelheim Investigational Site

City

Wien

Country

Austria

Facility Name

205.342.32010 Boehringer Ingelheim Investigational Site

City

Anderlecht

Country

Belgium

Facility Name

205.342.32005 Boehringer Ingelheim Investigational Site

City

Angleur

Country

Belgium

Facility Name

205.342.32002 Boehringer Ingelheim Investigational Site

City

Brussel

Country

Belgium

Facility Name

205.342.32007 Boehringer Ingelheim Investigational Site

City

Bruxelles

Country

Belgium

Facility Name

205.342.32014 Boehringer Ingelheim Investigational Site

City

Bruxelles

Country

Belgium

Facility Name

205.342.32001 Boehringer Ingelheim Investigational Site

City

Gent

Country

Belgium

Facility Name

205.342.32003 Boehringer Ingelheim Investigational Site

City

Herentals

Country

Belgium

Facility Name

205.342.32004 Boehringer Ingelheim Investigational Site

City

Malmédy

Country

Belgium

Facility Name

205.342.32012 Boehringer Ingelheim Investigational Site

City

Menen

Country

Belgium

Facility Name

205.342.32006 Boehringer Ingelheim Investigational Site

City

Montigny-le-Tilleul

Country

Belgium

Facility Name

205.342.32009 Boehringer Ingelheim Investigational Site

City

Namur

Country

Belgium

Facility Name

205.342.32011 Boehringer Ingelheim Investigational Site

City

Turnhout

Country

Belgium

Facility Name

205.342.32013 Boehringer Ingelheim Investigational Site

City

Yvoir

Country

Belgium

Facility Name

205.342.45003 Boehringer Ingelheim Investigational Site

City

Aalborg

Country

Denmark

Facility Name

205.342.45001 Boehringer Ingelheim Investigational Site

City

Hvidovre

Country

Denmark

Facility Name

205.342.45002 Boehringer Ingelheim Investigational Site

City

Kobenhavn NV

Country

Denmark

Facility Name

205.342.45004 Boehringer Ingelheim Investigational Site

City

Odense C

Country

Denmark

Facility Name

205.342.35803 Boehringer Ingelheim Investigational Site

City

Helsinki

Country

Finland

Facility Name

205.342.35801 Boehringer Ingelheim Investigational Site

City

Jyväskylä

Country

Finland

Facility Name

205.342.35802 Boehringer Ingelheim Investigational Site

City

Lahti

Country

Finland

Facility Name

205.342.35804 Boehringer Ingelheim Investigational Site

City

Tampere

Country

Finland

Facility Name

205.342.3305A Centre Hosp de la Cavale Blanche

City

Brest

Country

France

Facility Name

205.342.3304A Cabinet Médical

City

Chamalières

Country

France

Facility Name

205.342.3307A Boehringer Ingelheim Investigational Site

City

Chauny

Country

France

Facility Name

205.342.3301A UCP-X - Clinique Médicale

City

Grenoble

Country

France

Facility Name

205.342.3302A Hôpital Arnaud de Villeneuve

City

Montpellier

Country

France

Facility Name

205.342.3306A Mediscis

City

Poitiers

Country

France

Facility Name

205.342.3308A Boehringer Ingelheim Investigational Site

City

Saint Pierre la Réunion

Country

France

Facility Name

205.342.3308B Boehringer Ingelheim Investigational Site

City

Saint Pierre la Réunion

Country

France

Facility Name

205.342.49016 Boehringer Ingelheim Investigational Site

City

Beelitz-Heilstätten

Country

Germany

Facility Name

205.342.49004 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

205.342.49006 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

205.342.49013 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

205.342.49003 Boehringer Ingelheim Investigational Site

City

Bruchsal

Country

Germany

Facility Name

205.342.49011 Boehringer Ingelheim Investigational Site

City

Frankfurt/Main

Country

Germany

Facility Name

205.342.49007 Boehringer Ingelheim Investigational Site

City

Kassel

Country

Germany

Facility Name

205.342.49009 Boehringer Ingelheim Investigational Site

City

Köln

Country

Germany

Facility Name

205.342.49010 Boehringer Ingelheim Investigational Site

City

Mainz

Country

Germany

Facility Name

205.342.49008 Boehringer Ingelheim Investigational Site

City

Minden

Country

Germany

Facility Name

205.342.49015 Boehringer Ingelheim Investigational Site

City

Neuruppin

Country

Germany

Facility Name

205.342.49012 Boehringer Ingelheim Investigational Site

City

Rathenow

Country

Germany

Facility Name

205.342.49005 Boehringer Ingelheim Investigational Site

City

Rüdersdorf

Country

Germany

Facility Name

205.342.49002 Boehringer Ingelheim Investigational Site

City

Weinheim

Country

Germany

Facility Name

205.342.30001 Boehringer Ingelheim Investigational Site

City

Athens

Country

Greece

Facility Name

205.342.30002 Boehringer Ingelheim Investigational Site

City

Athens

Country

Greece

Facility Name

205.342.30005 Boehringer Ingelheim Investigational Site

City

Heraklion

Country

Greece

Facility Name

205.342.30006 Boehringer Ingelheim Investigational Site

City

Kavala

Country

Greece

Facility Name

205.342.30004 Boehringer Ingelheim Investigational Site

City

Larisa

Country

Greece

Facility Name

205.342.30003 Boehringer Ingelheim Investigational Site

City

Thessaloniki

Country

Greece

Facility Name

205.342.39003 Azienda Ospedaliera " S. Anna"

City

Ferrara

Country

Italy

Facility Name

205.342.39006 Azienda Ospedaliera Universitaria Careggi

City

Firenze

Country

Italy

Facility Name

205.342.39005 Ospedale San Martino

City

Genova

Country

Italy

Facility Name

205.342.39002 Università di Modena e Reggio Emilia

City

Modena

Country

Italy

Facility Name

205.342.39010 Boehringer Ingelheim Investigational Site

City

Orbassano (to)

Country

Italy

Facility Name

205.342.39007 Policlinico San Matteo

City

Pavia

Country

Italy

Facility Name

205.342.39001 Ospedale di Cisanello

City

Pisa

Country

Italy

Facility Name

205.342.39009 Boehringer Ingelheim Investigational Site

City

Sesto San Giovanni (mi)

Country

Italy

Facility Name

205.342.07001 Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

205.342.07002 Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

205.342.07003 Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

205.342.07004 Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

205.342.07005 Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

205.342.07006 Boehringer Ingelheim Investigational Site

City

St. Petersburg

Country

Russian Federation

Facility Name

205.342.07007 Boehringer Ingelheim Investigational Site

City

St. Petersburg

Country

Russian Federation

Facility Name

205.342.07008 Boehringer Ingelheim Investigational Site

City

St. Petersburg

Country

Russian Federation

Facility Name

205.342.42101 Boehringer Ingelheim Investigational Site

City

Banska Bystrica

Country

Slovakia

Facility Name

205.342.42102 Boehringer Ingelheim Investigational Site

City

Bratislava

Country

Slovakia

Facility Name

205.342.42104 Boehringer Ingelheim Investigational Site

City

Bratislava

Country

Slovakia

Facility Name

205.342.42105 Boehringer Ingelheim Investigational Site

City

Bratislava

Country

Slovakia

Facility Name

205.342.42107 Boehringer Ingelheim Investigational Site

City

Bratislava

Country

Slovakia

Facility Name

205.342.42103 Boehringer Ingelheim Investigational Site

City

Kosice

Country

Slovakia

Facility Name

205.342.42106 Boehringer Ingelheim Investigational Site

City

Trencin

Country

Slovakia

Facility Name

205.342.42108 Boehringer Ingelheim Investigational Site

City

Zilina

Country

Slovakia

Facility Name

205.342.27002 Boehringer Ingelheim Investigational Site

City

Bellville

Country

South Africa

Facility Name

205.342.27008 Boehringer Ingelheim Investigational Site

City

Bloemfontein

Country

South Africa

Facility Name

205.342.27001 Boehringer Ingelheim Investigational Site

City

Cape Town

Country

South Africa

Facility Name

205.342.27004 Boehringer Ingelheim Investigational Site

City

Cape Town

Country

South Africa

Facility Name

205.342.27006 Boehringer Ingelheim Investigational Site

City

Centurion

Country

South Africa

Facility Name

205.342.27003 Boehringer Ingelheim Investigational Site

City

Durban

Country

South Africa

Facility Name

205.342.27007 Boehringer Ingelheim Investigational Site

City

George

Country

South Africa

Facility Name

205.342.27005 Boehringer Ingelheim Investigational Site

City

Pretoria

Country

South Africa

Facility Name

205.342.34006 Hospital Clinic i Provincial de Barcelona

City

Barcelona

Country

Spain

Facility Name

205.342.34011 Boehringer Ingelheim Investigational Site

City

Centelles

Country

Spain

Facility Name

205.342.34004 Hospital General Universitario de Guadalajara

City

Guadalajara

Country

Spain

Facility Name

205.342.34002 Hospital de Gran Canaria Dr. Negrín

City

Las Palmas de Gran Canaria

Country

Spain

Facility Name

205.342.34007 Hospital Universitari Arnau de Vilanova

City

Lleida

Country

Spain

Facility Name

205.342.34003 Hospital Universitario La Paz

City

Madrid

Country

Spain

Facility Name

205.342.34009 Hospital Universio Puerta del Hierro

City

Madrid

Country

Spain

Facility Name

205.342.34008 Hospital Universitario Marqués de Valdecilla

City

Santander

Country

Spain

Facility Name

205.342.34005 Hospital Vírgen de la Macarena

City

Sevilla

Country

Spain

Facility Name

205.342.34010 Hospital General Universitario de Valencia

City

Valencia

Country

Spain

Facility Name

205.342.90001 Boehringer Ingelheim Investigational Site

City

Ankara

Country

Turkey

Facility Name

205.342.90006 Boehringer Ingelheim Investigational Site

City

Ankara

Country

Turkey

Facility Name

205.342.90003 Boehringer Ingelheim Investigational Site

City

Bursa

Country

Turkey

Facility Name

205.342.90007 Istanbul Universitesi Cerrahpasa Tip Fakultesi

City

Istanbul

Country

Turkey

Facility Name

205.342.90005 Kocaeli Universitesi Tip Fakultesi

City

Izmit

Country

Turkey

Facility Name

205.342.90004 Celal Bayar Universitesi Tip Fakultesi

City

Manisa

Country

Turkey

Facility Name

205.342.44002 Boehringer Ingelheim Investigational Site

City

Aylesbury

Country

United Kingdom

Facility Name

205.342.44001 Boehringer Ingelheim Investigational Site

City

Chertsey

Country

United Kingdom

Facility Name

205.342.44003 Boehringer Ingelheim Investigational Site

City

Greenisland

Country

United Kingdom

Facility Name

205.342.44006 Boehringer Ingelheim Investigational Site

City

Leicester

Country

United Kingdom

Facility Name

205.342.44005 Boehringer Ingelheim Investigational Site

City

Nottingham

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

21807250

Citation

Bateman ED, Kornmann O, Schmidt P, Pivovarova A, Engel M, Fabbri LM. Tiotropium is noninferior to salmeterol in maintaining improved lung function in B16-Arg/Arg patients with asthma. J Allergy Clin Immunol. 2011 Aug;128(2):315-22. doi: 10.1016/j.jaci.2011.06.004.

Results Reference

derived

Links:

URL

http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.342_U09-1701-01-DS.pdf

Description

Related Info

URL

http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.342_Literature.pdf

Description

Related Info

Learn more about this trial

Efficacy and Safety of Tiotropium and Salmeterol in Moderate Persistent Asthma Patients Homozygous for B16-Arg/Arg

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Efficacy and Safety of Tiotropium and Salmeterol in Moderate Persistent Asthma Patients Homozygous for B16-Arg/Arg

Asthma

About this trial

Eligibility Criteria

Sites / Locations

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