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P116 Clinically relevant attenuation of cough with gefapixant: a post hoc analysis

thoraxjnl · 2025-11-02 · canonical JSON source

13 visible annotations · policy: published · automated confidence ≥ 75.00%

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Introduction and Objectives Patient-reported outcomes (PROs) to assess refractory or unexplained chronic cough in phase 3 trials of gefapixant (COUGH-1/-2 [ NCT03449134, NCT03449147]) included the Leicester Cough Questionnaire (LCQ) and cough severity visual analog scale (VAS). Severity categories for these PROs anchored against the Patient Global Impression of Severity (PGIS) scale were recently defined (Rhatigan et al. J Allery Clin Immunol Pract. 2023;11:3706–3712). Here, we evaluate categories of cough severity in LCQ and VAS scores over time in COUGH-1/-2.Methods COUGH-1/-2 methods have previously been reported (McGarvey et al. Lancet. 2022;399:909–923). Post hoc analyses evaluated LCQ and cough severity VAS scores with gefapixant 45 mg twice daily and placebo based on PGIS cough severity thresholds. As the PGIS was not used in COUGH-1/-2, LCQ and VAS score ranges corresponding to the 6 PGIS categories (shown in figure 1) were based on Rhatigan et al.Results By Week 12, a higher percentage of participants treated with gefapixant vs placebo (35.9% vs 23.9%) had LCQ scores corresponding to the 2 lowest PGIS categories of minimal or no cough (figure 1A). By Week 52, respective percentages were 45.2% vs 34.8%. Cough severity VAS results were similar (Week 12, 26.9% vs 18.7%; Week 52, 42.5% vs 32.9%; figure 1B).Abstract P116 Figure 1Percentage of participants by PGIS categories for (A) LCQ and (B) cough severity VAS scores at baseline and over time of treatment with gefapixant 45 mg twice daily vs placebo. LCQ, Leicester Cough Questionnaire; PGIS, Patient Global Impression of Severity; VAS, visual analog scaleConclusions A sizeable and higher percentage of participants treated with gefapixant vs placebo experienced clinically relevant attenuation of cough, which increased over time.