Characterization of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease
Overview
- Phase
- Phase 3
- Intervention
- BI 1744 (Olodaterol) Medium Dose
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 100
- Locations
- 13
- Primary Endpoint
- FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After Six Weeks of Treatment
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The study is intended to characterize the lung function profile of BI1744 in COPD patients where patients will perform pulmonary function tests at regular intervals for 24 hours at the end of a 6 week treatment period. Each patient will receive all four treatments.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients willing to participate with confirmed diagnosis of COPD
- •40 years of age or older
- •having a 10 pack year smoking history
- •able to perform serial pulmonary function tests
- •able to use both a DPI and Respimat device
Exclusion Criteria
- •Significant other disease
- •clinically relevant abnormal hematology, chemistry, or urinalysis
- •history of asthma
- •diagnosis of thyrotoxicosis
- •paroxysmal tachycardia related to beta agonists
- •history of MI within 1 year, cardiac arrhythmia, hospitalization for heart failure within 1 year
- •active tuberculosis, cystic fibrosis, clinically evident bronchiectasis
- •significant alcohol or drug use
- •pulmonary resection
- •taking oral beta adrenergics
Arms & Interventions
BI1744 (Olodaterol)
Medium Dose once Daily
Intervention: BI 1744 (Olodaterol) Medium Dose
BI 1744 (Olodaterol)
Low Dose once Daily
Intervention: BI 1744 (Olodaterol) Low Dose
Placebo
Placebo once Daily
Intervention: Placebo
Foradil
12 mcg twice daily
Intervention: Foradil
Outcomes
Primary Outcomes
FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After Six Weeks of Treatment
Time Frame: 1 hour (h) and 10 minutes (min) prior to am dose on the first day of treatment (baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min relative to am dose after six weeks of treatment
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.
FEV1 Area Under Curve 12-24h (AUC 12-24h) Response After Six Weeks of Treatment
Time Frame: 1 h and 10 min prior to am dose on the first day of treatment (baseline) and 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.
Secondary Outcomes
- Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 h (AUC 0-24h) Response After Six Weeks of Treatment(1 h and 10 min prior to am dose on the first day of the treatment (baseline) and -30 min, 30 min, 60 min, 2h, 3h, 4h, 6h, 8h, 10h, 11 hr 50 min,12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment.)
- Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After Six Weeks of Treatment(1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to am dose after six weeks of treatment)
- Peak FEV1 (0-3h) Response(Baseline and 6 weeks)
- Trough FEV1 Response(Baseline and 6 weeks)
- Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response(1 hour (h) and 10 minutes (min) prior to am dose on the first day of treatment (baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min relative to am dose after six weeks of treatment)
- FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response(1 h and 10 min prior to am dose on the first day of treatment (baseline) and 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment)
- FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response(1 h and 10 min prior to am dose on the first day of treatment (baseline) and -30 min, 30 min, 60 min, 2h, 3h, 4h, 6h, 8h, 10h, 11 hr 50 min,12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment.)
- Peak FVC (0-3h) Response(Baseline and 6 weeks)
- Trough FVC Response(Baseline and 6 weeks)
- Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG(6 weeks)