Phase 3
Completed 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
Source: ClinicalTrials.gov NCT01040793 ↗
Enrolled (actual)
157
Serious AEs
3.1%
Results posted
Jul 2014
Primary outcomePrimary: Adjusted Mean Endurance Time After 6 Weeks — 354.33; 396.31; 391.45 seconds — p=0.0018
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.
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 | — |
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. Informational only — not medical advice.