The Leicester Cough Questionnaire in two phase 3 trials of gefapixant in chronic cough

Abstract

<b>Objective:</b> We assessed cough-specific health-related quality of life (HRQoL) using the Leicester Cough Questionnaire (LCQ), in two Phase 3 RCTs of gefapixant in refractory or unexplained chronic cough (RCC/UCC). <b>Methods:</b> In COUGH-1 (NCT03449134) and COUGH-2 (NCT3449147), RCC or UCC patients (duration ≥1 yr, screening/baseline cough severity VAS ≥40 mm) were randomized to placebo, gefapixant 15 mg BID, or gefapixant 45 mg BID for 52 weeks. Patients completed the LCQ, a 21-item questionnaire including 3 domains (7 items each): physical, psychological, and social. Comparison of responders (≥1.3-point increase from baseline in total score) for gefapixant vs. placebo were done with logistic regression analyses. <b>Results:</b> In 2044 RCC or UCC patients, mean total and individual domain scores over time demonstrated continued improvement in LCQ scores over 52 weeks (Figure). Odds ratios (95% CI) for achieving ≥1.3-point improvement in total LCQ scores were 1.39 (1.08, 1.78) and 1.42 (1.11, 1.83) at Week 12, 1.37 (1.06, 1.77) and 1.37 (1.06, 1.77) at Week 24, and 1.75 (1.33, 2.29) and 1.72 (1.31, 2.27) at Week 52 for gefapixant 15 and 45 mg, respectively, vs. placebo. <b>Conclusions:</b> A greater proportion of gefapixant patients achieved a meaningful improvement in LCQ total score than placebo throughout 52 weeks of treatment. HRQoL across all 3 domains of the LCQ improved over 52 weeks in COUGH-1 and COUGH-2.