This article is part of Pulmonology Advisor‘s coverage of the CHEST 2019 meeting, taking place in New Orleans, LA. Our staff will report on medical research related to asthma, COPD, critical care medicine, and more conducted by experts in the field. Check back regularly for more news from CHEST 2019.
NEW ORLEANS — Gefapixant has demonstrated efficacy in improving objective cough frequency and quality of life among individuals with chronic cough. This research was recently presented at the 2019 CHEST Annual Meeting, held October 19 to 23, 2019, in New Orleans, Louisiana.
This phase 2b, randomized controlled trial included 253 participants with acute chronic cough lasting >1 year. Participants were randomly assigned 1:1:1:1 to gefapixant 7.5 mg, 20 mg, 50 mg, or placebo for 12 weeks. The primary end point was 12-week Awake Objective Cough Frequency, with secondary end points including various measures of cough severity and quality of life: the 7-item Cough Severity Diary (CSD), the participant-rated Patient Global Impression of Change (PGIC), and the 19-item Leicester Cough Questionnaire (LCQ).
Compared with placebo, gefapixant 50 mg was associated with significant reduction in 12-week Awake Cough Frequency (P <.01), greater improvement in PGIC at week 12 (65% vs 30%; P <.0001), and greater change from baseline in CSD 12-week total score (-1.9 vs -1.2; P =.02). Subscale changes were -2.0±1.70 vs -1.3±1.75 for frequency (P =.06), -2.1±1.86 vs -1.2±1.73 for intensity (P =.02), and -1.6±1.24 vs -0.8±1.43 for disruption (P =.0003). For 50 mg vs placebo, the mean change in LCQ from baseline to week 12 was 4.2±4.13 vs 2.1±3.38 (P =.0028); domain score changes were 1.6±1.71 vs 0.8±1.41 for social (P =.0123), 1.2±1.15 vs 0.5±0.99 for physical (P =.0009), and 1.5±1.53 vs 0.8±1.38 for psychological (P =.0082).
“Improvements in [patient reported outcomes] in this trial are consistent with data on objective cough frequency reductions and indicate benefits related to quality of life,” the researchers concluded. In addition, they indicated that these improvements are particularly notable “with regard to disruption and psychological impact from cough.”
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
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Mehta A, Birring S, McGarvey L, et al. Benefits observed with patient-reported outcomes in a phase 2b clinical trial of gefapixant, a P2X3 receptor antagonist in chronic cough. Presented at: CHEST Annual Meeting 2019; October 19-23, 2019; New Orleans, LA. Abstract 1782.