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
NCT ID: NCT01040728
Last Updated: 2014-06-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
122 participants
INTERVENTIONAL
2010-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Olodaterol (BI1744) Low
Low dose inhaled orally once daily from Respimat inhaler
Olodaterol (BI1744) Low
Low dose inhaled orally once daily from Respimat inhaler
Olodaterol (BI1744) High
High dose inhaled orally once daily from Respimat inhaler
Olodaterol (BI1744) High
High dose inhaled orally once daily from Respimat inhaler
Tiotropium 18 mcg
18 mcg inhaled once daily from HandiHaler
Tiotropium 18 mcg
18 mcg inhaled once daily from HandiHaler
Placebo
Olodaterol placebo and/or Tiotropium placebo inhaled once daily
Placebo (for Olodaterol (BI1744)l)
Placebo (olodaterol low and high dose) delivered by Respimat
Placebo (for Tiotropium)
Placebo (Tiotropium 18 mcg) delivered by HandiHaler
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Olodaterol (BI1744) Low
Low dose inhaled orally once daily from Respimat inhaler
Olodaterol (BI1744) High
High dose inhaled orally once daily from Respimat inhaler
Tiotropium 18 mcg
18 mcg inhaled once daily from HandiHaler
Placebo (for Olodaterol (BI1744)l)
Placebo (olodaterol low and high dose) delivered by Respimat
Placebo (for Tiotropium)
Placebo (Tiotropium 18 mcg) delivered by HandiHaler
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boehringer Ingelheim
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Boehringer Ingelheim
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2009-014418-86
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1222.40
Identifier Type: -
Identifier Source: org_study_id