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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004966-13 | EudraCT Number |
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This study will assess the safety and efficacy of QAW039 when added to current therapy in patients that have sputum eosinophilia and persistent asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QAW039 | Experimental | Eligible patients will receive QAW039 po 450 mg daily dose. |
|
| Placebo | Placebo Comparator | Placebo to QAW039 (oral capsules) will be administered to match QAW039 schedule. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QAW039 | Drug | QAW039 was supplied as capsules for oral administration. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in sputum eosinophil percentage at week 12 (baseline measurement is defined as sputum eosinophil percentage at Day1 prior to the first dosing). | Sputum induction is performed through the inhalation of hypertonic saline. Sputum is collected and assessed for differential cellular content (absolute numbers and percentages). The primary variable will be summarized by treatment and analyzed using an ANCOVA model with treatment as the fixed effect and the respective baseline value as the covariate. | Visit 3 (day 1); Visit 5 (day 84) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to week 12 in Asthma Control Questionnaire (ACQ) | Participants complete the Asthma Control Questionnaire (ACQ). The ACQ has 7 equally weighted items; 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber Forced Expiratory Volume in one second (FEV1) % predicted. Items 1-6 are scored along a 7 point response scale, where 0 = good control and 6 = poor control. The 7th item on % predicted FEV1 (pre-bronchodilator) is scored by clinic staff on a 7 point scale. Secondary variables are summarized by treatment and analyzed using ANCOVA model with treatment as the fixed effect and the respective baseline value as covariate. |
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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 | Leicester | LE3 9QP | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27503237 | Derived | Gonem S, Berair R, Singapuri A, Hartley R, Laurencin MFM, Bacher G, Holzhauer B, Bourne M, Mistry V, Pavord ID, Mansur AH, Wardlaw AJ, Siddiqui SH, Kay RA, Brightling CE. Fevipiprant, a prostaglandin D2 receptor 2 antagonist, in patients with persistent eosinophilic asthma: a single-centre, randomised, double-blind, parallel-group, placebo-controlled trial. Lancet Respir Med. 2016 Sep;4(9):699-707. doi: 10.1016/S2213-2600(16)30179-5. Epub 2016 Aug 5. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C000604875 | fevipiprant |
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| Placebo |
| Drug |
Placebo was supplied as capsules for oral administration. |
|
| Visit 3 (day 1); Visit 5 (day 84) |
| Safety and tolerability of QAW039 in patients with moderate to severe asthma | All safety endpoints (including adverse events, laboratory data, vital signs and ECG) will be summarized by treatment group for all patients in the safety population. All data will be included in the analysis regardless of rescue medication use. | Visit 2 (day -14); Visit 3 (day 1); Visit 4 (day 42); Visit 5 (day 84); Visit 6 (day 126) |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |