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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01040130




Registration number
NCT01040130
Ethics application status
Date submitted
28/12/2009
Date registered
29/12/2009
Date last updated
8/07/2014

Titles & IDs
Public title
Effect of Treatment BI 1744 CL (5 and 10 mcg) Versus Placebo on Exercise Endurance Time During Constant Work Rate Cycle Ergometry I
Scientific title
Randomised, Double-blind, Placebo-controlled, 3-way Cross-over Study to Determine the Effect of Treatment of Orally Inhaled BI 1744 CL (5 µg [2 Actuations of 2.5 µg] and 10 µg [2 Actuations of 5 µg]) Delivered by the Respimat® Inhaler on Exercise Endurance Time During Constant Work Rate Cycle Ergometry in Patients With Chronic Obstructive Pulmonary Disease
Secondary ID [1] 0 0
2009-014395-21
Secondary ID [2] 0 0
1222.37
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Olodaterol (BI 1744)
Treatment: Drugs - Olodaterol (BI 1744)
Treatment: Drugs - Placebo
Treatment: Drugs - Olodaterol (BI 1744)
Treatment: Drugs - Olodaterol (BI 1744) Placebo

Experimental: Olodaterol (BI 1744) Low - Low dose inhaled orally once daily from the Respimat inhaler

Experimental: Olodaterol (BI 1744) High - High dose inhaled orally once daily from the Respimat inhaler

Placebo Comparator: Placebo - Olodaterol (BI 1744) placebo inhaled once daily from the Respimat inhaler


Treatment: Drugs: Olodaterol (BI 1744)
Comparison of low and high doses on exercise endurance time in COPD patients

Treatment: Drugs: Olodaterol (BI 1744)
Comparison of low and high doses on exercise endurance time in COPD patients

Treatment: Drugs: Placebo
Comparison of low and high dose and placebo on exercise endurance time in COPD patients

Treatment: Drugs: Olodaterol (BI 1744)
Comparison of low and high dose

Treatment: Drugs: Olodaterol (BI 1744) Placebo
Placebo that represents olodaterol
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adjusted Mean Endurance Time After 6 Weeks
Timepoint [1] 0 0
6 weeks
Secondary outcome [1] 0 0
Adjusted Mean Inspiratory Capacity at Isotime After 6 Weeks
Timepoint [1] 0 0
6 weeks
Secondary outcome [2] 0 0
Adjusted Mean Borg Scale of Breathing Discomfort at Isotime After 6 Weeks
Timepoint [2] 0 0
6 weeks
Secondary outcome [3] 0 0
Adjusted Mean Inspiratory Capacity at Pre-exercise After 6 Weeks
Timepoint [3] 0 0
6 weeks
Secondary outcome [4] 0 0
Adjusted Mean Inspiratory Capacity at End of Exercise After 6 Weeks
Timepoint [4] 0 0
6 weeks
Secondary outcome [5] 0 0
Adjusted Mean Borg Scale of Breathing Discomfort at Pre-exercise After 6 Weeks
Timepoint [5] 0 0
6 weeks
Secondary outcome [6] 0 0
Adjusted Mean Borg Scale of Breathing Discomfort at End of Exercise After 6 Weeks
Timepoint [6] 0 0
6 weeks
Secondary outcome [7] 0 0
Adjusted Mean Functional Residual Capacity 30 Minutes Pre-dose After 6 Weeks
Timepoint [7] 0 0
6 weeks
Secondary outcome [8] 0 0
Adjusted Mean Functional Residual Capacity 1 Hour Post-dose After 6 Weeks
Timepoint [8] 0 0
6 weeks
Secondary outcome [9] 0 0
Adjusted Mean Inspiratory Capacity 30 Minutes Pre-dose After 6 Weeks
Timepoint [9] 0 0
6 weeks
Secondary outcome [10] 0 0
Adjusted Mean Inspiratory Capacity 1 Hour Post-dose After 6 Weeks
Timepoint [10] 0 0
6 weeks
Secondary outcome [11] 0 0
Adjusted Mean Total Lung Capacity 30 Minutes Pre-dose After 6 Weeks
Timepoint [11] 0 0
6 weeks
Secondary outcome [12] 0 0
Adjusted Mean Total Lung Capacity 1 Hour Post-dose After 6 Weeks
Timepoint [12] 0 0
6 weeks
Secondary outcome [13] 0 0
Adjusted Mean Forced Expiratory Volume in 1 Second, 30 Minutes Pre-dose After 6 Weeks
Timepoint [13] 0 0
6 weeks
Secondary outcome [14] 0 0
Adjusted Mean Forced Expiratory Volume in 1 Second, 1 Hour Post-dose After 6 Weeks
Timepoint [14] 0 0
6 weeks
Secondary outcome [15] 0 0
Adjusted Mean Forced Vital Capacity, 30 Minutes Pre-dose After 6 Weeks
Timepoint [15] 0 0
6 weeks
Secondary outcome [16] 0 0
Adjusted Mean Forced Vital Capacity, 1 Hour Post-dose After 6 Weeks
Timepoint [16] 0 0
6 weeks
Secondary outcome [17] 0 0
Adjusted Mean Peak Expiratory Flow Rate, 30 Minutes Pre-dose After 6 Weeks
Timepoint [17] 0 0
6 weeks
Secondary outcome [18] 0 0
Adjusted Mean Peak Expiratory Flow Rate, 1 Hour Post-dose After 6 Weeks
Timepoint [18] 0 0
6 weeks
Secondary outcome [19] 0 0
Change From Baseline to Day 43 in Blood Pressure
Timepoint [19] 0 0
Baseline and Week 6
Secondary outcome [20] 0 0
Change From Baseline to Day 43 in Pulse Rate
Timepoint [20] 0 0
Baseline and Week 6
Secondary outcome [21] 0 0
Number of Patients With Notable Changes in Heart Rate
Timepoint [21] 0 0
Baseline and Week 6
Secondary outcome [22] 0 0
Number of Patients With Notable Increase in PR Intervals
Timepoint [22] 0 0
Baseline and Week 6
Secondary outcome [23] 0 0
Number of Patients With Notable Increase in QRS Intervals
Timepoint [23] 0 0
Baseline and Week 6

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Signed informed consent prior to participation.

2. Diagnosis of chronic obstructive pulmonary disease and post-bronchodilator FEV1(Forced
Expiratory Volume in 1 sec) <80% of predicted normal and post-bronchodilator
FEV1(Forced Expiratory Volume in 1 sec)/FVC of < 70% at Visit 1.

3. Male or female between 40 and 75 years of age.

4. Current or ex-smokers with smoking history of more than 10-pack years.

5. Able to perform technically acceptable pulmonary function tests, multiple exercise
tests and able to maintain records.

6. Able to inhale medication in a competent manner from a metered-dose inhaler and
Respimat inhaler.
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or
urinalysis; all patients with an SGOT >x2 ULN, SGPT >x2 ULN, bilirubin >x2 ULN or
creatinine >x2 ULN.

2. Patients with a history of asthma and/or total blood eosinophil count of 600
cells/mm3.

3. Patients with thyrotoxicosis, paroxysmal tachycardia (>100 beats per minute).

4. Patients with a history of myocardial infarction within 1 year of screening visit,
unstable or life-threatening cardiac arrhythmia, hospitalization for heart failure
within the past year, known active tuberculosis, a malignancy for which patient has
undergone resection, radiation therapy or chemotherapy within last five years,
life-threatening pulmonary obstruction, cystic fibrosis, clinically evident
bronchiectasis, significant alcohol or drug abuse or contraindications to exercise.

5. Patients who have undergone thoracotomy with pulmonary resection.

6. Patients being treated with oral beta-adrenergics or oral corticosteroid medication at
unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of
the equivalent of 10 mg of prednisone per day or 20 mg every other day.

7. Patients who regularly use daytime oxygen for more than one hour per day.

8. Patients who have completed a pulmonary rehabilitation program in the six weeks prior
to the screening visit or patients who are currently in a pulmonary rehabilitation
program.

9. Patients who have a limitation of exercise performance as a result of factors other
than fatigue or exertional dyspnea.

10. Pregnant or nursing women.

11. Women of childbearing potential not using two effective methods of birth control (one
barrier and one non-barrier).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
151
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
1222.37.6171 Boehringer Ingelheim Investigational Site - Daw Park
Recruitment hospital [2] 0 0
1222.37.6174 Boehringer Ingelheim Investigational Site - Clayton
Recruitment hospital [3] 0 0
1222.37.6173 Boehringer Ingelheim Investigational Site - Heidelberg
Recruitment hospital [4] 0 0
1222.37.6172 Boehringer Ingelheim Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
- Daw Park
Recruitment postcode(s) [2] 0 0
- Clayton
Recruitment postcode(s) [3] 0 0
- Heidelberg
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Gänserndorf
Country [2] 0 0
Austria
State/province [2] 0 0
Neumarkt am Wallersee
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Canada
State/province [4] 0 0
Quebec
Country [5] 0 0
France
State/province [5] 0 0
Bethune Cedex
Country [6] 0 0
France
State/province [6] 0 0
Montpellier
Country [7] 0 0
France
State/province [7] 0 0
Nîmes
Country [8] 0 0
France
State/province [8] 0 0
Paris
Country [9] 0 0
France
State/province [9] 0 0
Perpignan
Country [10] 0 0
France
State/province [10] 0 0
Strasbourg
Country [11] 0 0
Germany
State/province [11] 0 0
Berlin
Country [12] 0 0
Germany
State/province [12] 0 0
Halle
Country [13] 0 0
Germany
State/province [13] 0 0
Magdeburg
Country [14] 0 0
Germany
State/province [14] 0 0
Rüdersdorf

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To compare the effects of BI 1744 CL versus placebo on exercise tolerance after 6 weeks of
treatment in patients with Chronic Obstructive Pulmonary Disease
Trial website
https://clinicaltrials.gov/ct2/show/NCT01040130
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries