A randomized, double-blind, placebo-controlled study of the CRTH2 antagonist OC000459 in moderate persistent asthma

This was a randomized, double-blind, parallel-group trial designed to evaluate the effects of OC000459 versus placebo on lung function, symptoms, and eosinophilic airway inflammation in 132 adult patients with moderate persistent asthma. The primary endpoint was change from baseline in pre-bronchodilator FEV1; secondary endpoints included clinic-recorded FVC and PEF, diary-recorded PEF, asthma symptoms, QoL, rescue therapy usage, induced sputum differential eosinophil count, and serum IgE levels. Clinic spirometry was undertaken using a Vitalograph spirometer using Spirotrac software. Home spirometry was performed using the Vitalograph In2itive e-Diary, with PEF values, symptoms, and study drug usage recorded on a daily basis.