Dose Finding Study for QAW039 in Asthma

Phase 2 Completed 1043 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study aims to demonstrate a clinically significant improvement in Forced Expiratory Volume in one second (FEV1) in moderate to severe allergic asthmatics inadequately controlled by Inhaled Corticosteroid (ICS) therapy. Patients will be treated with QAW039, an active comparator, or placebo. This will be a randomized, placebo-controlled, dose-ranging, multi-centre trial.

Timeline

Start: 2011-08
Primary completion: 2013-11
Completion: 2013-11

Outcome

Met primary endpoint

paper Fevipiprant produced a statistically significant improvement in the primary end-point of change in pre-dose forced expiratory volume in 1 s at week 12 (p=0.0035) PMID 28838980 ↗

Publications

Bateman ED, Guerreros AG, Brockhaus F, Holzhauer B, Pethe A, Kay RA, Townley RG. Fevipiprant, an oral prostaglandin DP2 receptor (CRTh2) antagonist, in allergic asthma uncontrolled on low-dose inhaled corticosteroids. Eur Respir J. 2017 Aug 24;50(2):1700670. doi: 10.1183/13993003.00670-2017. Print 2017 Aug.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Montelukast	Other / unclassified	10 mg	Oral
Subject	fevipiprant	Small molecule	1 mg	Oral
Subject	fevipiprant	Small molecule	2 mg	Oral
Subject	fevipiprant	Small molecule	3 mg	Oral
Subject	fevipiprant	Small molecule	10 mg	Oral
Subject	fevipiprant	Small molecule	25 mg	Oral
Subject	fevipiprant	Small molecule	30 mg	Oral
Subject	fevipiprant	Small molecule	50 mg	Oral
Subject	fevipiprant	Small molecule	75 mg	Oral
Subject	fevipiprant	Small molecule	150 mg	Oral
Subject	fevipiprant	Small molecule	300 mg	Oral
Subject	fevipiprant	Small molecule	450 mg	Oral