Characterisation of 24-hour FEV1-time Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Registration Number
- NCT00932646
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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
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
- taking unstable oral steroids
- daytime oxygen
- enrolled in rehabilitation program
- enrolled in another study or taking investigational products
- pregnant or nursing women, women of child bearing potential not willing to use two methods of birth control
- those who are not willing to comply with pulmonary medication washouts
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo once Daily BI1744 (Olodaterol) BI 1744 (Olodaterol) Medium Dose Medium Dose once Daily BI 1744 (Olodaterol) BI 1744 (Olodaterol) Low Dose Low Dose once Daily Foradil Foradil 12 mcg twice daily
- Primary Outcome Measures
Name Time Method FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After Six Weeks of Treatment 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 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 Outcome Measures
Name Time Method 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. Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.
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 Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 0-3h was calculated from 0-3hours post-dose using the trapezoidal rule, divided by the observation time (3 h) to report in litres.
Peak FEV1 (0-3h) Response Baseline and 6 weeks Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Peak values were obtained within 0 - 3 hours after the last am dose after six weeks of treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.
Trough FEV1 Response Baseline and 6 weeks Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Trough values were obtained 30 minutes prior to the last am dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.
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 Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FVC AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres.
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 Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FVC AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.
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. Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FVC AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.
Peak FVC (0-3h) Response Baseline and 6 weeks Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Peak FVC was obtained within 0 - 3 hours after the last am dose of study drug after 6 weeks of treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.
Trough FVC Response Baseline and 6 weeks Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Trough values were obtained 30 minutes prior to the last am dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG 6 weeks Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).
Trial Locations
- Locations (13)
1222.25.25009 Boehringer Ingelheim Investigational Site
🇺🇸Jasper, Alabama, United States
1222.25.25010 Boehringer Ingelheim Investigational Site
🇺🇸Austell, Georgia, United States
1222.25.25008 Boehringer Ingelheim Investigational Site
🇺🇸Albuquerque, New Mexico, United States
1222.25.25012 Boehringer Ingelheim Investigational Site
🇺🇸Charlotte, North Carolina, United States
1222.25.25004 Boehringer Ingelheim Investigational Site
🇺🇸Raleigh, North Carolina, United States
1222.25.25013 Boehringer Ingelheim Investigational Site
🇺🇸Richmond, Virginia, United States
1222.25.25002 Boehringer Ingelheim Investigational Site
🇺🇸Clearwater, Florida, United States
1222.25.25006 Boehringer Ingelheim Investigational Site
🇺🇸Knoxville, Tennessee, United States
1222.25.25014 Boehringer Ingelheim Investigational Site
🇺🇸Seneca, South Carolina, United States
1222.25.25003 Boehringer Ingelheim Investigational Site
🇺🇸Deland, Florida, United States
1222.25.25007 Boehringer Ingelheim Investigational Site
🇺🇸Winter Park, Florida, United States
1222.25.25005 Boehringer Ingelheim Investigational Site
🇺🇸Houston, Texas, United States
1222.25.25011 Boehringer Ingelheim Investigational Site
🇺🇸Columbus, Ohio, United States