- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00931385
Characterization of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease
May 29, 2014 updated by: Boehringer Ingelheim
Characterisation of 24-hour FEV1-time Profiles of Inhaled BI 1744 CL and Inhaled Foradil Iin Patients With Chronic Obstructive Pulmonary Disease
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
99
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
-
-
Florida
-
Tampa, Florida, United States
- 1222.24.24011 Boehringer Ingelheim Investigational Site
-
-
Kansas
-
Overland Park, Kansas, United States
- 1222.24.24009 Boehringer Ingelheim Investigational Site
-
-
Louisiana
-
Lafayette, Louisiana, United States
- 1222.24.24007 Boehringer Ingelheim Investigational Site
-
-
Ohio
-
Cincinnati, Ohio, United States
- 1222.24.24002 Boehringer Ingelheim Investigational Site
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States
- 1222.24.24010 Boehringer Ingelheim Investigational Site
-
-
South Carolina
-
Easley, South Carolina, United States
- 1222.24.24004 Boehringer Ingelheim Investigational Site
-
Gaffney, South Carolina, United States
- 1222.24.24006 Boehringer Ingelheim Investigational Site
-
Greenville, South Carolina, United States
- 1222.24.24005 Boehringer Ingelheim Investigational Site
-
Greenville, South Carolina, United States
- 1222.24.24008 Boehringer Ingelheim Investigational Site
-
Spartanburg, South Carolina, United States
- 1222.24.24001 Boehringer Ingelheim Investigational Site
-
Union, South Carolina, United States
- 1222.24.24003 Boehringer Ingelheim Investigational Site
-
-
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 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 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 Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo once daily
|
Placebo Respimat and Foradil Placebo
|
Experimental: BI 1744 (Olodaterol) Low Dose
BI1744 Low Dose once daily
|
1744 low dose
|
Experimental: BI 1744 (Olodaterol) Med Dose
BI 1744 Med Dose once daily
|
BI1744 Respimat Med Dose Once Daily
|
Active Comparator: Foradil
Foradil 12 mcg twice daily
|
Foradil 12 mcg twice daily and Placebo Respimat
|
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 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.
|
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
|
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.
|
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
|
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
|
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
|
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 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.
|
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
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 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
|
FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response
Time Frame: 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.
|
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.
|
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 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 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 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
Time Frame: 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 the last 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.
|
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 the last am dose after six weeks of treatment
|
Peak FEV1 (0-3h) Response
Time Frame: Baseline and 6 weeks
|
Response was defined as change from baseline.
Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values at the randomisation visit.
Peak (0-3h) 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
|
Trough FEV1 Response
Time Frame: Baseline and 6 weeks
|
Response was defined as change from baseline.
Study baseline trough FEV1 was defined as the mean of the available pre-dose trough 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
|
Peak FVC (0-3h) Response
Time Frame: Baseline and 6 weeks
|
Response was defined as change from baseline.
Study baseline peak FVC was defined as the mean of the available pre-dose peak FVC values at the randomisation visit.
Peak FVC (0-3h) 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
|
Trough FVC Response
Time Frame: Baseline and 6 weeks
|
Response was defined as change from baseline.
Study baseline trough FVC was defined as the mean of the available pre-dose trough 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
|
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
June 1, 2009
Primary Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
July 1, 2009
First Submitted That Met QC Criteria
July 1, 2009
First Posted (Estimate)
July 2, 2009
Study Record Updates
Last Update Posted (Estimate)
July 1, 2014
Last Update Submitted That Met QC Criteria
May 29, 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
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Formoterol Fumarate
Other Study ID Numbers
- 1222.24
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.
Clinical Trials on Pulmonary Disease, Chronic Obstructive
-
Spire, Inc.ResMedCompletedSevere Chronic Obstructive Pulmonary Disease | Moderate Chronic Obstructive Pulmonary DiseaseUnited States
-
Karaganda Medical UniversityCompletedChronic Obstructive Pulmonary Disease | Chronic Obstructive Pulmonary Disease Moderate | Chronic Obstructive Pulmonary Disease SevereKazakhstan
-
Randall DebattistaUniversity of Malta, Faculty of Health SciencesNot yet recruitingChronic Obstructive Pulmonary Disease Moderate | Acute Exacerbation of COPD | Chronic Obstructive Pulmonary Disease Severe
-
Cukurova UniversityCompletedAnesthesia | Chronic Obstructive Pulmonary Disease Moderate | Lungcancer | Chronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease MildTurkey
-
National Taipei University of Nursing and Health...TerminatedChronic Pulmonary Disease | Chronic Obstructive Pulmonary Disease Exacerbation | Chronic Obstructive Pulmonary Disease With ExacerbationTaiwan
-
Taipei Medical UniversityUnknownChronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease End StageTaiwan
-
Kırıkkale UniversityRecruitingCOPD (Chronic Obstructive Pulmonary Disease)Turkey
-
Hopital FochAir Liquide SARecruitingChronic Obstructive Pulmonary Disease SevereFrance
-
Fundación para la Investigación del Hospital Clínico...Not yet recruitingCOPD, Chronic Obstructive Pulmonary DiseaseSpain
-
Canandaigua VA Medical CenterRecruitingChronic Obstructive Pulmonary Disease ModerateUnited States
Clinical Trials on bi1744
-
Boehringer IngelheimCompletedPulmonary Disease, Chronic ObstructiveBelgium, Denmark, Germany, Hungary
-
Boehringer IngelheimCompletedPulmonary Disease, Chronic ObstructiveUnited States, Germany, Netherlands, Norway
-
Boehringer IngelheimCompletedPulmonary Disease, Chronic ObstructiveUnited States, Australia, China, Germany, New Zealand, Taiwan
-
Boehringer IngelheimCompletedPulmonary Disease, Chronic ObstructiveAustria, Belgium, Canada, Germany, Russian Federation