Responder analysis of Leicester Cough Questionnaire domains from phase 3 trials of gefapixant (COUGH-1/COUGH-2)

<bold>Background:</bold> In phase 3 trials of refractory or unexplained chronic cough, a higher percentage of participants (pts) receiving gefapixant 45 mg twice daily (BID) vs placebo (pbo) were Leicester Cough Questionnaire (LCQ) total score responders (≥1.3-point increase) after 52 weeks. Response to gefapixant across LCQ domains has not been reported. <bold>Aims and objectives:</bold> To evaluate improvement in LCQ domains with gefapixant treatment. <bold>Methods:</bold> Post hoc domain-level LCQ responder analyses were calculated for pts who received gefapixant 45 mg BID or pbo through Week 52 (COUGH-1, <ext-link>NCT03449134</ext-link>; COUGH-2, <ext-link>NCT03449147</ext-link>; pooled). Responders were defined by the following increases in domain scores from baseline: social, ≥0.8 points; psychological, ≥0.9 points; physical, ≥0.8 points (Martin Nguyen et al. Ther Adv Respir Dis. 2022;16:1-13). <bold>Results:</bold> Of 1299 pts (gefapixant, n=655; pbo, n=644), a greater percentage receiving gefapixant vs pbo were LCQ domain responders through Week 52 (social, 69.5% vs 59.3%; psychological, 65.6% vs 55.1%; physical, 62.1% vs 52.5%; Figure A). Odds of achieving a clinically meaningful response across domains were greater with gefapixant (Figure B). <bold>Conclusions:</bold> A higher percentage of pts receiving gefapixant reported clinically meaningful improvements in LCQ social, psychological, and physical domains vs pbo, supporting the broad benefit of gefapixant on cough-specific quality of life. <fig><object-id>erj;64/suppl_68/PA323/F1</object-id><object-id>F1</object-id><object-id>F1</object-id><graphic></graphic></fig>