Phase 3
N=157
Effect of Treatment BI 1744 CL (5 and 10 mcg) Versus Placebo on Exercise Endurance Time During Constant Work Rate Cycle Ergometry II
Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT01040793 ↗Enrolled (actual)
157
Serious AEs
3.1%
Results posted
Jul 2014
Primary outcome: Primary: Adjusted Mean Endurance Time After 6 Weeks — 354.33; 396.31; 391.45 seconds — p=0.0018
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Olodaterol (BI 1744) (Drug); Placebo (Drug); Olodaterol (BI1744) (Drug); Olodaterol (BI 1744) placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Mean Endurance Time After 6 Weeks |
354.33; 396.31; 391.45 | 0.0018 sig |
| SECONDARY Adjusted Mean Inspiratory Capacity at Isotime After 6 Weeks |
2.162; 2.246; 2.328 | 0.0155 sig |
| SECONDARY Adjusted Mean Borg Scale of Breathing Discomfort at Isotime After 6 Weeks |
5.585; 5.250; 5.520 | 0.1176 |
| SECONDARY Adjusted Mean Inspiratory Capacity at Pre-exercise After 6 Weeks |
2.273; 2.437; 2.468 | <0.0001 sig |
| SECONDARY Adjusted Mean Inspiratory Capacity at End of Exercise After 6 Weeks |
2.158; 2.236; 2.330 | 0.0245 sig |
| SECONDARY Adjusted Mean Borg Scale of Breathing Discomfort at Pre-exercise After 6 Weeks |
0.389; 0.315; 0.364 | 0.2897 |
| SECONDARY Adjusted Mean Borg Scale of Breathing Discomfort at End of Exercise After 6 Weeks |
7.010; 7.101; 7.351 | 0.5313 |
| SECONDARY Adjusted Mean Functional Residual Capacity 30 Minutes Pre-dose After 6 Weeks |
4.842; 4.757; 4.723 | 0.1048 |
| SECONDARY Adjusted Mean Functional Residual Capacity 1 Hour Post-dose After 6 Weeks |
4.770; 4.557; 4.583 | <0.0001 sig |
| SECONDARY Adjusted Mean Inspiratory Capacity 30 Minutes Pre-dose After 6 Weeks |
2.463; 2.613; 2.618 | 0.0002 sig |
| SECONDARY Adjusted Mean Inspiratory Capacity 1 Hour Post-dose After 6 Weeks |
2.493; 2.725; 2.696 | <0.0001 sig |
| SECONDARY Adjusted Mean Total Lung Capacity 30 Minutes Pre-dose After 6 Weeks |
7.311; 7.368; 7.340 | 0.3109 |
| SECONDARY Adjusted Mean Total Lung Capacity 1 Hour Post-dose After 6 Weeks |
7.262; 7.285; 7.272 | 0.6809 |
| SECONDARY Adjusted Mean Forced Expiratory Volume in 1 Second, 30 Minutes Pre-dose After 6 Weeks |
1.520; 1.630; 1.630 | <0.0001 sig |
| SECONDARY Adjusted Mean Forced Expiratory Volume in 1 Second, 1 Hour Post-dose After 6 Weeks |
1.577; 1.768; 1.771 | <0.0001 sig |
| SECONDARY Adjusted Mean Forced Vital Capacity, 30 Minutes Pre-dose After 6 Weeks |
3.103; 3.222; 3.222 | 0.0013 sig |
| SECONDARY Adjusted Mean Forced Vital Capacity, 1 Hour Post-dose After 6 Weeks |
3.144; 3.409; 3.425 | <0.0001 sig |
| SECONDARY Adjusted Mean Peak Expiratory Flow Rate, 30 Minutes Pre-dose After 6 Weeks |
4.258; 4.539; 4.549 | <0.0001 sig |
| SECONDARY Adjusted Mean Peak Expiratory Flow Rate, 1 Hour Post-dose After 6 Weeks |
4.324; 4.904; 4.876 | <0.0001 sig |
| SECONDARY Change From Baseline to Day 43 in Blood Pressure |
-0.5; -1.5; -1.4; -0.8; -1.8; -2.2 | — |
| SECONDARY Change From Baseline to Day 43 in Pulse Rate |
-2.3; -1.8; -1.6 | — |
| SECONDARY Number of Patients With Notable Changes in Heart Rate |
0.7; 0.7; 0.0; 0.7; 1.4; 2.9 | — |
| SECONDARY Number of Patients With Notable Increase in PR Intervals |
0.0; 0.0; 0.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Number of Patients With Notable Increase in QRS Intervals |
0.7; 0.7; 0.7; 99.3; 99.3; 99.3 | — |
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.
Eligibility Criteria
Inclusion criteria
- Signed informed consent prior to participation.
- Diagnosis of chronic obstructive pulmonary disease and post-bronchodilator FEV1(Forced Expiratory Volume in 1 sec) x2 ULN, SGPT >x2 ULN, bilirubin >x2 ULN or creatinine >x2 ULN.
- Patients with a history of asthma and/or total blood eosinophil count of 600 cells/mm3.
- Patients with thyrotoxicosis, paroxysmal tachycardia (>100 beats per minute).
- 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.
- Patients who have undergone thoracotomy with pulmonary resection.
- 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.
- Patients who regularly use daytime oxygen for more than one hour per day.
- 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.
- Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnea.
- Pregnant or nursing women.
- Women of childbearing potential not using two effective methods of birth control (one barrier and one non-barrier).
Data sourced from ClinicalTrials.gov (NCT01040793). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.