Characterisation of 24-hour FEV1-time Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Characterization of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00932646
• Other study ID #: 1222.25
• Status: Completed
• Phase: Phase 3
• First received: July 2, 2009
• Last updated: January 11, 2016
• Start date: June 2009

Study information

• Verified date: January 2016
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

• 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• BI 1744 (Olodaterol) Low Dose
BI1744 Respimat low dose once daily and placebo Foradil
• BI 1744 (Olodaterol) Medium Dose
BI1744 Respimat medium dose once daily and placebo Foradil
• Placebo
Placebo Respimat once daily and placebo Foradil
• Foradil
12 mcg twice daily and placebo Respimat

Locations

Country	Name	City	State
United States	1222.25.25008 Boehringer Ingelheim Investigational Site	Albuquerque	New Mexico
United States	1222.25.25010 Boehringer Ingelheim Investigational Site	Austell	Georgia
United States	1222.25.25012 Boehringer Ingelheim Investigational Site	Charlotte	North Carolina
United States	1222.25.25002 Boehringer Ingelheim Investigational Site	Clearwater	Florida
United States	1222.25.25011 Boehringer Ingelheim Investigational Site	Columbus	Ohio
United States	1222.25.25003 Boehringer Ingelheim Investigational Site	Deland	Florida
United States	1222.25.25005 Boehringer Ingelheim Investigational Site	Houston	Texas
United States	1222.25.25009 Boehringer Ingelheim Investigational Site	Jasper	Alabama
United States	1222.25.25006 Boehringer Ingelheim Investigational Site	Knoxville	Tennessee
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	1222.25.25014 Boehringer Ingelheim Investigational Site	Seneca	South Carolina
United States	1222.25.25007 Boehringer Ingelheim Investigational Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response 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.	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	No
Primary	FEV1 Area Under Curve 12-24h (AUC 12-24h) Response 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.	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	No
Secondary	Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 h (AUC 0-24h) Response 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.	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.	No
Secondary	Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response 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.	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	No
Secondary	Peak FEV1 (0-3h) Response	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.	Baseline and 6 weeks	No
Secondary	Trough FEV1 Response	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.	Baseline and 6 weeks	No
Secondary	Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response	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.	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	No
Secondary	FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response	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.	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	No
Secondary	FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response	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.	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.	No
Secondary	Peak FVC (0-3h) Response	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.	Baseline and 6 weeks	No
Secondary	Trough FVC Response	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.	Baseline and 6 weeks	No
Secondary	Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG	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).	6 weeks	No

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