A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease
Randomised, Double-blind, Double-dummy, Placebo-controlled, 4-way Cross-over Study to Characterise the 24-hour 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)
2 other identifiers
interventional
122
4 countries
12
Brief Summary
The study is intended to characterize the lung function profile of BI1744 in Chronic Obstructive Pulmonary Disease (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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 29, 2009
CompletedFirst Posted
Study publicly available on registry
December 30, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedResults Posted
Study results publicly available
June 30, 2014
CompletedJune 30, 2014
May 1, 2014
1 year
December 29, 2009
March 28, 2014
May 28, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
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 for the first period, just prior to administration of the first 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.
1 hour (h) and 10 minutes (min) prior to the 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
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 for the first period, just prior to administration of the first 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.
1 h and 10 min prior to the 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
Secondary Outcomes (14)
Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 h (AUC 0-24h) Response After Six Weeks of Treatment
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
Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After First Dose of Treatment
1 hour (h) prior and 10 minutes (min) prior to the am 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 the first dose of treatment period
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 the am 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 the first dose of treatment after six weeks of treatment
Peak FEV1 (0-3h) Response
Study baseline and first day of dosing
Peak FEV1 (0-3h) Response
Study baseline and 6 weeks
- +9 more secondary outcomes
Study Arms (4)
Olodaterol (BI1744) Low
EXPERIMENTALLow dose inhaled orally once daily from Respimat inhaler
Olodaterol (BI1744) High
EXPERIMENTALHigh dose inhaled orally once daily from Respimat inhaler
Tiotropium 18 mcg
ACTIVE COMPARATOR18 mcg inhaled once daily from HandiHaler
Placebo
PLACEBO COMPARATOROlodaterol placebo and/or Tiotropium placebo inhaled once daily
Interventions
Low dose inhaled orally once daily from Respimat inhaler
High dose inhaled orally once daily from Respimat inhaler
Placebo (olodaterol low and high dose) delivered by Respimat
Eligibility Criteria
You may qualify if:
- Patients willing to participate with confirmed diagnosis of COPD
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
1222.40.11003 Boehringer Ingelheim Investigational Site
Jasper, Alabama, United States
1222.40.11001 Boehringer Ingelheim Investigational Site
Clearwater, Florida, United States
1222.40.11002 Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
1222.40.49401 Boehringer Ingelheim Investigational Site
Berlin, Germany
1222.40.49403 Boehringer Ingelheim Investigational Site
Berlin, Germany
1222.40.49402 Boehringer Ingelheim Investigational Site
Hanover, Germany
1222.40.31003 Boehringer Ingelheim Investigational Site
Breda, Netherlands
1222.40.31002 Boehringer Ingelheim Investigational Site
Eindhoven, Netherlands
1222.40.31001 Boehringer Ingelheim Investigational Site
Heerlen, Netherlands
1222.40.47003 Boehringer Ingelheim Investigational Site
Arendal, Norway
1222.40.47002 Boehringer Ingelheim Investigational Site
Drammen, Norway
1222.40.47001 Boehringer Ingelheim Investigational Site
Trondheim, Norway
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim Call Center
- Organization
- Boehringer Ingelheim Pharmaceuticals
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 29, 2009
First Posted
December 30, 2009
Study Start
January 1, 2010
Primary Completion
January 1, 2011
Last Updated
June 30, 2014
Results First Posted
June 30, 2014
Record last verified: 2014-05