Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
170 participants
INTERVENTIONAL
2010-11-30
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
QAW039 capsules once daily for 28 days
QAW039 capsules once daily for 28 days
2
Placebo to QAW039 capsules once daily for 28 days
Placebo to QAW039 capsules once daily for 28 days
3
Fluticasone propionate inhaler twice daily for 28 days
Fluticasone propionate inhaler twice daily for 28 days
Interventions
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QAW039 capsules once daily for 28 days
Placebo to QAW039 capsules once daily for 28 days
Fluticasone propionate inhaler twice daily for 28 days
Eligibility Criteria
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Inclusion Criteria
* Patients must weigh at least 45 kg to participate in the study, and must have abody mass index (BMI) of \>17 kg/m2.
* Female patients must be surgically sterilized, postmenopausal or using a double-barrier method of contraception
Exclusion Criteria
* Smokers defined as history of smoking in the previous 6 months or a smoking history of more than 10 pack years, a pack year being defined as smoking the equivalent of 20 cigarettes - a pack - every day for the period of 1 year
* Patients with severe persistent asthma
18 Years
65 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Encinitas, California, United States
Novartis Investigative Site
Huntington Beach, California, United States
Novartis Investigative Site
Los Angeles, California, United States
Novartis Investigative Site
Los Angeles, California, United States
Novartis Investigative Site
Mission Viejo, California, United States
Novartis Investigative Site
San Diego, California, United States
Novartis Investigative Site
San Diego, California, United States
Novartis Investigative Site
San Jose, California, United States
Novartis Investigative Site
Stockton, California, United States
Novartis Investigative Site
Stockbridge, Georgia, United States
Novartis Investigative Site
North Dartmouth, Massachusetts, United States
Novartis Investigative Site
Bellevue, Nebraska, United States
Novartis Investigative Site
Berlin, New Jersey, United States
Novartis Investigative Site
Skillman, New Jersey, United States
Novartis Investigative Site
Raleigh, North Carolina, United States
Novartis Investigative Site
Medford, Oregon, United States
Novatis Investigative Site
Upland, Pennsylvania, United States
Novartis Investigative Site
Dallas, Texas, United States
Novartis Investigative Site
Jambes, , Belgium
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Cologne, , Germany
Novartis Investigative Site
Frankfurt, , Germany
Novartis Investigative Site
Hamburg, , Germany
Novartis Investigative Site
Wiesbaden, , Germany
Novartis Investigative Site
Bucharest, , Romania
Novartis Investigative Site
Seoul, , South Korea
Countries
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References
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Erpenbeck VJ, Popov TA, Miller D, Weinstein SF, Spector S, Magnusson B, Osuntokun W, Goldsmith P, Weiss M, Beier J. The oral CRTh2 antagonist QAW039 (fevipiprant): A phase II study in uncontrolled allergic asthma. Pulm Pharmacol Ther. 2016 Aug;39:54-63. doi: 10.1016/j.pupt.2016.06.005. Epub 2016 Jun 21.
Related Links
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Results for CQAW039A2201 from the Novartis Clinical Trials website
Other Identifiers
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2010-020177-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CQAW039A2201
Identifier Type: -
Identifier Source: org_study_id