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
Completed · Phase 3 · Has a placebo group
Conditions studied: Pulmonary Disease, Chronic Obstructive
In brief
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.
Key facts
- Study ID
- NCT01040728
- Run by
- Boehringer Ingelheim
- People needed
- 122
- Starts
- 2010-01-01
- Last updated by the study team
- 2014-06-30
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
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
- those who are not willing to comply with pulmonary medication washouts
Where it is running
- 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
Full record on ClinicalTrials.gov
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