Outcome Measures
hypogeusia, ageusia, dysgeusia, Cough, hypergeusia
ADVERSE EVENTS, SECONDARY, TASTE DISORDER
Our hypothesis was that gefapixant is superior to placebo in improving cough-specific health status in patients with ROCC. The primary efficacy outcome was the Leicester Cough Questionnaire (LCQ) and was analyzed as the total score change from baseline at Week 12. A within-patient 1.3-point increase from baseline in total LCQ is considered to be a clinically meaningful improvement (i.e., responder) [The secondary efficacy endpoint was the change from baseline in Cough Severity VAS score at Week 12. We also evaluated the Cough Severity Diary (CSD). For both VAS and CSD, a mean weekly total score was calculated from the daily scores.The Patient Global Impression of Change (PGIC) and the Work Productivity and Activity Impairment (WPAI) questionnaires were administered and evaluated as exploratory endpoints. Further descriptions of the efficacy outcome measurements are detailed in the Supplement.Assessments of adverse events (AE) and discontinuations due to AEs were additional secondary objectives in this study. AEs were assessed by clinical evaluation. Other study parameters including vital signs, physical examination, and laboratory safety tests were also evaluated. Investigators evaluated AEs for relationship to study medication, intensity, and seriousness. Taste-related AEs (i.e., ageusia, dysgeusia, hypergeusia, hypogeusia, and taste disorder) were predefined as AEs of special interest.