Abstract
Introduction
QAV680 is an oral, selective, competitive, and reversible CRTh2 antagonist. This study assessed the effect of an antihistamine, QAV680 or a combination of the two in the treatment of ragweed pollen-induced allergic rhinitis in an environmental exposure chamber (EEC).
Methods
In this double-blind, 3-period incomplete crossover study (NCT01103050), patients (pts) with seasonal allergic rhinitis were randomised (1:1:1:1) to either QAV680 500mg qid, cetirizine (CTZ) 10mg od, a combination of the two, or placebo (PBO) for 14 days. Efficacy on total nasal and ocular symptom score (TNSS and TOSS, respectively), PK and safety data was determined.
Results
Of the 60 pts randomised, 48 completed the study. The combination therapy QAV680+CTZ, and monotherapies (QAV680, CTZ) significantly reduced TNSS (averaged over last 2hrs of 8hrs of allergen exposure EEC, day 14) and TOSS compared with PBO (table). QAV680, CTZ and the combination were well tolerated with comparable numbers of subjects with adverse events in each treatment group (QAV680+CTZ=16.3%; QAV680=32.5%; CTZ=23.3%; PBO=15.8%). No deaths or SAEs were reported and PK data were consistent with previous phase I studies.
Conclusion
QAV680, cetirizine and their combination were well tolerated and significantly reduced nasal and ocular symptoms versus placebo in patients with intermittent seasonal allergic rhinitis.
- © 2014 ERS