Safety and Efficacy of QAW039 in Sputum Eosinophilia and Persistent Asthma

Phase 2 Completed 61 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will assess the safety and efficacy of QAW039 when added to current therapy in patients that have sputum eosinophilia and persistent asthma.

Timeline

Start: 2012-02
Primary completion: 2013-06
Completion: 2013-06

Outcome

Met primary endpoint

paper Compared with baseline, mean sputum eosinophil percentage was reduced by 4·5 times in the fevipiprant group and by 1·3 times in the placebo group PMID 27503237 ↗

paper difference between groups 3·5 times, 95% CI 1·7-7·0; p=0·0014 PMID 27503237 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	fevipiprant	Small molecule	450 mg	Oral