- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01040689
Characterization of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease
May 28, 2014 updated by: Boehringer Ingelheim
Randomised, Double-blind, Double-dummy, Placebo-controlled, 4-way Cross-over Study to Characterise the 24-hour Forced, Expiratory Volume After 1 Second (FEV1) Time Profiles of BI 1744 CL 5µg and 10µg (Oral Inhalation, Delivered by the Respimat® Inhaler) and Tiotropium Bromide 18µg (Oral Inhalation, Delivered by the HandiHaler®) After 6 Weeks of Treatment in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
108
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Genk, Belgium
- 1222.39.32003 Boehringer Ingelheim Investigational Site
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Gent, Belgium
- 1222.39.32001 Boehringer Ingelheim Investigational Site
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Hasselt, Belgium
- 1222.39.32002 Boehringer Ingelheim Investigational Site
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Hvidovre, Denmark
- 1222.39.45001 Boehringer Ingelheim Investigational Site
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Kolding, Denmark
- 1222.39.45003 Boehringer Ingelheim Investigational Site
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Odense C, Denmark
- 1222.39.45002 Boehringer Ingelheim Investigational Site
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Berlin, Germany
- 1222.39.49391 Boehringer Ingelheim Investigational Site
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Hamburg, Germany
- 1222.39.49392 Boehringer Ingelheim Investigational Site
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Mannheim, Germany
- 1222.39.49393 Boehringer Ingelheim Investigational Site
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Deszk, Hungary
- 1222.39.36006 Boehringer Ingelheim Investigational Site
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Farkasgyepü, Hungary
- 1222.39.36004 Boehringer Ingelheim Investigational Site
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Pecs, Hungary
- 1222.39.36005 Boehringer Ingelheim Investigational Site
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Szarvas, Hungary
- 1222.39.36003 Boehringer Ingelheim Investigational Site
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Szeged, Hungary
- 1222.39.36001 Boehringer Ingelheim Investigational Site
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Törökbalint, Hungary
- 1222.39.36002 Boehringer Ingelheim Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Dry powder inhaler (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 abuse
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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PLACEBO_COMPARATOR: Placebo
olodaterol placebo and/or Tiotropium placebo inhaled once daily
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Placebo (Tiotropium 18 mcg) delivered by HandiHaler
Placebo (olodaterol low and high dose)delivered by Respimat
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EXPERIMENTAL: Olodaterol (BI1744) Low
Low dose inhaled orally once daily from Respimat inhaler
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Low dose inhaled orally once daily from Respimat inhaler
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EXPERIMENTAL: Olodaterol (BI1744) High
High dose inhaled orally once daily from Respimat inhaler
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High dose inhaled orally once daily from Respimat inhaler
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ACTIVE_COMPARATOR: Tiotropium 18 mcg
18mcg inhaled once daily from Handihaler
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18mcg inhaled once daily from Handihaler
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 the first treatment period (study baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 12 h relative to am dose after six weeks of treatment
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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 for the first period, just prior to administration of the morning dose of randomized treatment.
Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.
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.
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1 hour (h) and 10 minutes (min) prior to am dose on the first day of the first treatment period (study baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 12 h relative to am dose after six weeks of treatment
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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 the first treatment period (study baseline) and 12 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment
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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 for the first period, just prior to administration of the morning dose of randomized treatment.
Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.
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.
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1 h and 10 min prior to am dose on the first day of the first treatment period (study baseline) and 12 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG
Time Frame: 6 weeks
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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).
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6 weeks
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Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 h (AUC 0-24h) Response After Six Weeks of Treatment
Time Frame: 1 hour (h) and 10 minutes (min) prior to am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h, 4 h, 6h, 8h, 10h, 12 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment
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Response was defined as change from baseline.
Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the first visit of the first treatment period.
Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.
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.
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1 hour (h) and 10 minutes (min) prior to am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h, 4 h, 6h, 8h, 10h, 12 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment
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Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After First Dose of Treatment
Time Frame: 1 hour (h) prior and 10 minutes (min) prior to first dose of the first period (study baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to the first dose of treatment period
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Response was defined as change from baseline.
Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of the first treatment period.
Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.
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.
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1 hour (h) prior and 10 minutes (min) prior to first dose of the first period (study baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to the first dose of treatment period
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Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After Six Weeks of Treatment
Time Frame: 1 hour (h) prior and 10 minutes (min) prior to first dose of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to the last dose of treatment after six weeks of treatment.
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Response was defined as change from baseline.
Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of the first treatment period.
Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.
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.
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1 hour (h) prior and 10 minutes (min) prior to first dose of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to the last dose of treatment after six weeks of treatment.
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Peak FEV1 (0-3h) Response
Time Frame: Study baseline and first day of dosing
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Response was defined as change from baseline.
Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of first treatment period.
Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after the first dose of treatment.
Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.
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Study baseline and first day of dosing
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Peak FEV1 (0-3h) Response
Time Frame: Study baseline and 6 weeks
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Response was defined as change from baseline.
Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of first treatment period.
Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after the last dose after six weeks of treatment.
Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.
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Study baseline and 6 weeks
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Trough FEV1 Response
Time Frame: Study baseline and 6 weeks
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Response was defined as change from baseline.
Study baseline trough FEV1 was defined as the mean of the available pre-dose trough FEV1 values prior to first dose of first treatment period.
Trough values were the mean of values obtained 23 hours and 23h 50min post the last dose of study drug after six weeks of treatment .
Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.
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Study baseline and 6 weeks
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Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response
Time Frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of the first treatment period (study baseline) and -30 min (zero time), 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12h relative to last dose after six weeks of treatment.
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Response was defined as change from baseline.
Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to first dose in first treatment period.
Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.
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 dose on the first day of the first treatment period (study baseline) and -30 min (zero time), 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12h relative to last dose after six weeks of treatment.
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FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response
Time Frame: 1 h and 10 min prior to dose on the first day of the first treatment period (study baseline) and 12 h, 22 h, 23 h, and 23 h 50 min relative to last 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 prior to first dose of first treatment period.
Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.
FVC AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.
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1 h and 10 min prior to dose on the first day of the first treatment period (study baseline) and 12 h, 22 h, 23 h, and 23 h 50 min relative to last dose after six weeks of treatment
|
FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response
Time Frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h, 4 h, 6h, 8h, 10h, 12 h, 22 h, 23 h, and 23 h 50 min relative to last 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 prior to first dose in first treatment period.
Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.
FVC AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.
|
1 hour (h) and 10 minutes (min) prior to dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h, 4 h, 6h, 8h, 10h, 12 h, 22 h, 23 h, and 23 h 50 min relative to last dose after six weeks of treatment.
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FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response
Time Frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of the treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h relative to first dose of treatment
|
Response was defined as change from baseline.
Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose in the first treatment period.
Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.
FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.
|
1 hour (h) and 10 minutes (min) prior to dose on the first day of the treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h relative to first dose of treatment
|
FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response
Time Frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h relative to last 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 prior to the first dose in the first treatment period.
Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.
FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.
|
1 hour (h) and 10 minutes (min) prior to dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h relative to last dose after six weeks of treatment.
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Peak FVC (0-3h) Response
Time Frame: Study baseline and 6 weeks
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Response was defined as change from baseline.
Study baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose in first treatment period.
Peak FVC (0-3h) was obtained within 0 - 3 hours after the last dose of study drug after 6 weeks of treatment.
Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.
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Study baseline and 6 weeks
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Trough FVC Response
Time Frame: Study baseline and 6 weeks
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Response was defined as change from baseline.
Study baseline trough FVC was defined as the mean of the available pre-dose trough FVC values prior to first dose in first treatment period.
Trough values were mean of the values obtained 23 h and 23 h 50 min after the last dose of study drug after six weeks of treatment.
Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.
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Study baseline and 6 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (ACTUAL)
January 1, 2011
Study Registration Dates
First Submitted
December 29, 2009
First Submitted That Met QC Criteria
December 29, 2009
First Posted (ESTIMATE)
December 30, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
June 30, 2014
Last Update Submitted That Met QC Criteria
May 28, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Antagonists
- Cholinergic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Tiotropium Bromide
- Olodaterol
Other Study ID Numbers
- 1222.39
- 2009-014417-27 (EUDRACT_NUMBER: EudraCT)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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