A Study to Compare the Efficacy and Safety of Different Dosings of Olodaterol Administered With the Respimat® Inhaler in Patients With Moderate to Severe Asthma
NCT ID: NCT01311661
Last Updated: 2014-05-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
206 participants
INTERVENTIONAL
2011-03-31
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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Olodaterol medium daily dose
Olodaterol medium daily dose given either as once daily or split into two low doses daily or placebo only in randomised sequence of three cross-over treatment phases
Olodaterol low daily dose twice daily
Inhaled Olodaterol medium daily dose administered as low dose twice daily
Placebo twice daily
Inhaled Placebo of Olodaterol twice daily
Olodaterol medium daily dose once daily and placebo
Inhaled Olodaterol medium daily dose administered as one full dose once daily and placebo once daily
Olodaterol high daily dose
Olodaterol high daily dose given either as once daily or split into two medium doses daily or placebo only in randomised sequence of three cross-over treatment phases
Placebo twice daily
Inhaled Placebo of Olodaterol twice daily
Olodaterol medium daily dose twice daily
Inhaled Olodaterol high daily dose administered as medium dose twice daily
Olodaterol high daily dose once daily and placebo
Inhaled Olodaterol high daily dose administered as one full dose once daily and placebo once daily
Interventions
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Placebo twice daily
Inhaled Placebo of Olodaterol twice daily
Olodaterol low daily dose twice daily
Inhaled Olodaterol medium daily dose administered as low dose twice daily
Olodaterol medium daily dose twice daily
Inhaled Olodaterol high daily dose administered as medium dose twice daily
Placebo twice daily
Inhaled Placebo of Olodaterol twice daily
Olodaterol high daily dose once daily and placebo
Inhaled Olodaterol high daily dose administered as one full dose once daily and placebo once daily
Olodaterol medium daily dose once daily and placebo
Inhaled Olodaterol medium daily dose administered as one full dose once daily and placebo once daily
Eligibility Criteria
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Inclusion Criteria
2. Aged 18 to 70 years.
3. A current diagnosis and a documented minimum 3 month history of asthma Global Initiative for Asthma (GINA) treatment steps 3 and 4.
4. Prebronchodilator Forced Expiratory Volume in one second (FEV1) \>= 60% predicted and \< 90% predicted according to European Coal and Steel Community (ECSC).
5. Increase in FEV1 \>=12% and \>=200 mL 15 min. after 400 µg salbutamol (albuterol);
6. Stable on medium to high dose inhaled corticosteroids (ICS) or low to high dose ICS in combination with a long acting beta-adrenergics (LABA) for at least 6 weeks prior to screening. Stable on ICS mono component of the former fixed LABA/ICS treatment for at least 48 hours prior to Visit 1b.
Exclusion Criteria
2. History of frequent seasonal exacerbations of asthma (defined as one or more seasonal exacerbations every year for the past three years).
3. Upper respiratory tract infection in the past 3 weeks prior to screening visit 1b.
4. Oral or other systemic corticosteroids in the past 6 weeks.
5. Patients with allergen desensitization therapy if started within two years, if they are not on an established maintenance regimen characterized by dose adjustments but no further increase to the tolerable maximum in the same course of immunotherapy.
18 Years
70 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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1222.29.11006 Boehringer Ingelheim Investigational Site
Huntington Beach, California, United States
1222.29.11001 Boehringer Ingelheim Investigational Site
Centennial, Colorado, United States
1222.29.11012 Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado, United States
1222.29.11002 Boehringer Ingelheim Investigational Site
Overland Park, Kansas, United States
1222.29.11004 Boehringer Ingelheim Investigational Site
North Dartmouth, Massachusetts, United States
1222.29.11011 Boehringer Ingelheim Investigational Site
St Louis, Missouri, United States
1222.29.11009 Boehringer Ingelheim Investigational Site
Skillman, New Jersey, United States
1222.29.11003 Boehringer Ingelheim Investigational Site
Raleigh, North Carolina, United States
1222.29.11008 Boehringer Ingelheim Investigational Site
Canton, Ohio, United States
1222.29.11007 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
1222.29.11005 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina, United States
1222.29.11010 Boehringer Ingelheim Investigational Site
Richmond, Virginia, United States
1222.29.43003 Boehringer Ingelheim Investigational Site
Linz, , Austria
1222.29.43002 Boehringer Ingelheim Investigational Site
Schlüsslberg, , Austria
1222.29.43001 Boehringer Ingelheim Investigational Site
Thalheim bei Wels, , Austria
1222.29.43004 Boehringer Ingelheim Investigational Site
Wels, , Austria
1222.29.49004 Boehringer Ingelheim Investigational Site
Berlin, , Germany
1222.29.49006 Boehringer Ingelheim Investigational Site
Berlin, , Germany
1222.29.49007 Boehringer Ingelheim Investigational Site
Berlin, , Germany
1222.29.49008 Boehringer Ingelheim Investigational Site
Berlin, , Germany
1222.29.49002 Boehringer Ingelheim Investigational Site
Frankfurt, , Germany
1222.29.49010 Boehringer Ingelheim Investigational Site
Großhansdorf, , Germany
1222.29.49003 Boehringer Ingelheim Investigational Site
Lübeck, , Germany
1222.29.49005 Boehringer Ingelheim Investigational Site
Rüdersdorf, , Germany
1222.29.49001 Boehringer Ingelheim Investigational Site
Wiesbaden, , Germany
1222.29.49009 Boehringer Ingelheim Investigational Site
Wiesloch, , Germany
1222.29.36002 Boehringer Ingelheim Investigational Site
Mosonmagyaróvár, , Hungary
1222.29.36003 Boehringer Ingelheim Investigational Site
Nyíregyháza, , Hungary
1222.29.36001 Boehringer Ingelheim Investigational Site
Sopron, , Hungary
1222.29.36004 Boehringer Ingelheim Investigational Site
Zalaegerszeg, , Hungary
1222.29.42001 Boehringer Ingelheim Investigational Site
Bardejov, , Slovakia
1222.29.42002 Boehringer Ingelheim Investigational Site
Martin, , Slovakia
1222.29.42004 Boehringer Ingelheim Investigational Site
Nitra, , Slovakia
1222.29.42003 Boehringer Ingelheim Investigational Site
Spišská Nová Ves, , Slovakia
1222.29.38003 Boehringer Ingelheim Investigational Site
Golnik, , Slovenia
1222.29.38002 Boehringer Ingelheim Investigational Site
Kamnik, , Slovenia
Countries
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References
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Beeh KM, LaForce C, Gahlemann M, Wenz A, Toorawa R, Flezar M. Randomised, double-blind, placebo-controlled crossover study to investigate different dosing regimens of olodaterol delivered via Respimat(R) in patients with moderate to severe persistent asthma. Respir Res. 2015 Jul 16;16(1):87. doi: 10.1186/s12931-015-0243-1.
Other Identifiers
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2008-006625-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1222.29
Identifier Type: -
Identifier Source: org_study_id
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