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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020177-16 | EudraCT Number |
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This study will assess the safety, efficacy and pharmacokinetics of QAW039 in steroid-free patients with mild to moderate persistent asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | QAW039 capsules once daily for 28 days |
|
| 2 | Experimental | Placebo to QAW039 capsules once daily for 28 days |
|
| 3 | Experimental | Fluticasone propionate inhaler twice daily for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QAW039 capsules once daily for 28 days | Drug |
| ||
| Placebo to QAW039 capsules once daily for 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in trough forced expiratory volume in 1 second (FEV1) compared to placebo. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety of a 28 day administration of QAW039 compared to placebo, measured by vital signs, laboratory evaluations and electrocardiograms. | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Encinitas | California | 92024 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27354118 | Derived | 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. |
| Label | URL |
|---|---|
| Results for CQAW039A2201 from the Novartis Clinical Trials website | View source |
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| Drug |
|
| Fluticasone propionate inhaler twice daily for 28 days | Drug |
|
| Huntington Beach |
| California |
| 92647 |
| United States |
| Novartis Investigative Site | Los Angeles | California | 90025 | United States |
| Novartis Investigative Site | Los Angeles | California | 90048 | United States |
| Novartis Investigative Site | Mission Viejo | California | 92691 | United States |
| Novartis Investigative Site | San Diego | California | 92120 | United States |
| Novartis Investigative Site | San Diego | California | 92123 | United States |
| Novartis Investigative Site | San Jose | California | 95117 | United States |
| Novartis Investigative Site | Stockton | California | 95207 | United States |
| Novartis Investigative Site | Stockbridge | Georgia | 30281 | United States |
| Novartis Investigative Site | North Dartmouth | Massachusetts | 02747 | United States |
| Novartis Investigative Site | Bellevue | Nebraska | 68123 | United States |
| Novartis Investigative Site | Berlin | New Jersey | 08009 | United States |
| Novartis Investigative Site | Skillman | New Jersey | 08558 | United States |
| Novartis Investigative Site | Raleigh | North Carolina | 27607 | United States |
| Novartis Investigative Site | Medford | Oregon | 97504 | United States |
| Novatis Investigative Site | Upland | Pennsylvania | 19013 | United States |
| Novartis Investigative Site | Dallas | Texas | 75231 | 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 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000604875 | fevipiprant |
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