Study Design
cough
This multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 2b trial was conducted at 112 study sites in Europe, the United States, and Japan (NCT04110054). Adults who met the inclusion criteria at screening Visit 1 (18–28 days before randomization) were enrolled and underwent 24-h cough monitoring using the VitaloJAK™ cough monitor [Patients who continued to meet the screening criteria at Visit 3 were randomized in a 1:1:1:1 ratio (93 patients per treatment group) to receive sivopixant 50, 150, or 300 mg or placebo OD for 4 weeks (e-Fig. 1, Online Resource). Randomization was stratified by region (Europe, the United States, or Japan) and 24-h cough count at Visit 1 (≥ 30 or < 30 coughs/h).The randomization schedule was maintained by interactive response technology until data lock. The sponsor, investigator, and all study-site personnel were blinded to treatment assignment until data lock.Placebo tablets matched in appearance with the sivopixant 50-mg tablet, and the labeling and packaging of sivopixant and placebo were identical. Patients were followed up for safety for 2 weeks after their last dose.