Phase 3
N=151
Effect of Treatment BI 1744 CL (5 and 10 mcg) Versus Placebo on Exercise Endurance Time During Constant Work Rate Cycle Ergometry I
Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT01040130 ↗Enrolled (actual)
151
Serious AEs
2.1%
Results posted
Jul 2014
Primary outcome: Primary: Adjusted Mean Endurance Time After 6 Weeks — 369.81; 421.58; 420.72 seconds — p=0.0002
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Olodaterol (BI 1744) (Drug); Placebo (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 |
369.81; 421.58; 420.72 | 0.0002 sig |
| SECONDARY Adjusted Mean Inspiratory Capacity at Isotime After 6 Weeks |
1.917; 2.099; 2.091 | <0.0001 sig |
| SECONDARY Adjusted Mean Borg Scale of Breathing Discomfort at Isotime After 6 Weeks |
5.870; 5.104; 5.235 | 0.0007 sig |
| SECONDARY Adjusted Mean Inspiratory Capacity at Pre-exercise After 6 Weeks |
2.220; 2.478; 2.513 | <0.0001 sig |
| SECONDARY Adjusted Mean Inspiratory Capacity at End of Exercise After 6 Weeks |
1.887; 2.067; 2.024 | <0.0001 sig |
| SECONDARY Adjusted Mean Borg Scale of Breathing Discomfort at Pre-exercise After 6 Weeks |
0.288; 0.185; 0.224 | 0.0447 sig |
| SECONDARY Adjusted Mean Borg Scale of Breathing Discomfort at End of Exercise After 6 Weeks |
6.978; 6.890; 7.234 | 0.5698 |
| SECONDARY Adjusted Mean Functional Residual Capacity 30 Minutes Pre-dose After 6 Weeks |
4.977; 4.855; 4.862 | 0.0784 |
| SECONDARY Adjusted Mean Functional Residual Capacity 1 Hour Post-dose After 6 Weeks |
4.950; 4.740; 4.577 | 0.0015 sig |
| SECONDARY Adjusted Mean Inspiratory Capacity 30 Minutes Pre-dose After 6 Weeks |
2.170; 2.289; 2.262 | 0.0005 sig |
| SECONDARY Adjusted Mean Inspiratory Capacity 1 Hour Post-dose After 6 Weeks |
2.221; 2.427; 2.437 | <0.0001 sig |
| SECONDARY Adjusted Mean Total Lung Capacity 30 Minutes Pre-dose After 6 Weeks |
7.142; 7.148; 7.121 | 0.9239 |
| SECONDARY Adjusted Mean Total Lung Capacity 1 Hour Post-dose After 6 Weeks |
7.156; 7.142; 6.997 | 0.8302 |
| SECONDARY Adjusted Mean Forced Expiratory Volume in 1 Second, 30 Minutes Pre-dose After 6 Weeks |
1.475; 1.564; 1.576 | <0.0001 sig |
| SECONDARY Adjusted Mean Forced Expiratory Volume in 1 Second, 1 Hour Post-dose After 6 Weeks |
1.473; 1.698; 1.699 | <0.0001 sig |
| SECONDARY Adjusted Mean Forced Vital Capacity, 30 Minutes Pre-dose After 6 Weeks |
3.212; 3.319; 3.310 | 0.0006 sig |
| SECONDARY Adjusted Mean Forced Vital Capacity, 1 Hour Post-dose After 6 Weeks |
3.187; 3.471; 3.477 | <0.0001 sig |
| SECONDARY Adjusted Mean Peak Expiratory Flow Rate, 30 Minutes Pre-dose After 6 Weeks |
4.374; 4.692; 4.677 | <0.0001 sig |
| SECONDARY Adjusted Mean Peak Expiratory Flow Rate, 1 Hour Post-dose After 6 Weeks |
4.363; 4.949; 4.981 | <0.0001 sig |
| SECONDARY Change From Baseline to Day 43 in Blood Pressure |
-3.5; -2.7; -3.3; -1.7; -1.8; -1.1 | — |
| SECONDARY Change From Baseline to Day 43 in Pulse Rate |
-5.1; -5.1; -3 | — |
| SECONDARY Number of Patients With Notable Changes in Heart Rate |
0.7; 0.7; 0.7; 1.4; 2.9; 2.1 | — |
| SECONDARY Number of Patients With Notable Increase in PR Intervals |
0.0; 0.7; 0.0; 100.0; 99.3; 100.0 | — |
| SECONDARY Number of Patients With Notable Increase in QRS Intervals |
0.7; 0.7; 0.0; 99.3; 99.3; 100.0 | — |
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 (NCT01040130). 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.