Characterization of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease
NCT ID: NCT01040689
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
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COMPLETED
PHASE3
108 participants
INTERVENTIONAL
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Placebo
olodaterol placebo and/or Tiotropium placebo inhaled once daily
Placebo (for olodaterol BI1744)
Placebo (olodaterol low and high dose)delivered by Respimat
Placebo (for Tiotropium)
Placebo (Tiotropium 18 mcg) delivered by HandiHaler
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
18mcg inhaled once daily from Handihaler
Tiotropium 18 mcg
18mcg inhaled once daily from Handihaler
Interventions
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Olodaterol (BI1744) Low
Low dose inhaled orally once daily from Respimat inhaler
Placebo (for olodaterol BI1744)
Placebo (olodaterol low and high dose)delivered by Respimat
Placebo (for Tiotropium)
Placebo (Tiotropium 18 mcg) delivered by HandiHaler
Olodaterol (BI1744) High
High dose inhaled orally once daily from Respimat inhaler
Tiotropium 18 mcg
18mcg inhaled once daily from Handihaler
Eligibility Criteria
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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
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Boehringer Ingelheim
Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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1222.39.32003 Boehringer Ingelheim Investigational Site
Genk, , Belgium
1222.39.32001 Boehringer Ingelheim Investigational Site
Ghent, , Belgium
1222.39.32002 Boehringer Ingelheim Investigational Site
Hasselt, , Belgium
1222.39.45001 Boehringer Ingelheim Investigational Site
Hvidovre, , Denmark
1222.39.45003 Boehringer Ingelheim Investigational Site
Kolding, , Denmark
1222.39.45002 Boehringer Ingelheim Investigational Site
Odense C, , Denmark
1222.39.49391 Boehringer Ingelheim Investigational Site
Berlin, , Germany
1222.39.49392 Boehringer Ingelheim Investigational Site
Hamburg, , Germany
1222.39.49393 Boehringer Ingelheim Investigational Site
Mannheim, , Germany
1222.39.36006 Boehringer Ingelheim Investigational Site
Deszk, , Hungary
1222.39.36004 Boehringer Ingelheim Investigational Site
Farkasgyepü, , Hungary
1222.39.36005 Boehringer Ingelheim Investigational Site
Pécs, , Hungary
1222.39.36003 Boehringer Ingelheim Investigational Site
Szarvas, , Hungary
1222.39.36001 Boehringer Ingelheim Investigational Site
Szeged, , Hungary
1222.39.36002 Boehringer Ingelheim Investigational Site
Törökbálint, , Hungary
Countries
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Other Identifiers
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2009-014417-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1222.39
Identifier Type: -
Identifier Source: org_study_id