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Late Breaking Abstract - Two Phase 3 Randomized Clinical Trials of Gefapixant, a P2X3 Receptor Antagonist, in Refractory or Unexplained Chronic Cough (COUGH-1 and COUGH-2)

Lorcan McGarvey, Surinder Birring, Alyn Morice, Peter Dicpinigaitis, Ian Pavord, Jonathan Schelfhout, Allison Martin Nguyen, Qing Li, Anjela Tzontcheva, Beata Iskold, Stuart Green, Carmen La Rosa, David Muccino, Jaclyn Smith
European Respiratory Journal 2020 56: 3800; DOI: 10.1183/13993003.congress-2020.3800
Lorcan McGarvey
1Centre for Experimental Medicine, Queen’s University Belfast, Belfast, UK, Belfast, United Kingdom
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  • For correspondence: l.mcgarvey@qub.ac.uk
Surinder Birring
2Centre for Human & Applied Physiological Sciences, King's College London, London, United Kingdom
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Alyn Morice
3Hull York Medical School, Cottingham, United Kingdom
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Peter Dicpinigaitis
4Albert Einstein College of Medicine and Montefiore Medical Center, New York, United States of America
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Ian Pavord
5Oxford NIHR Respiratory BRC, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom
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Jonathan Schelfhout
6Merck & Co., Inc., Kenilworth, United States of America
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Allison Martin Nguyen
6Merck & Co., Inc., Kenilworth, United States of America
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Qing Li
6Merck & Co., Inc., Kenilworth, United States of America
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Anjela Tzontcheva
6Merck & Co., Inc., Kenilworth, United States of America
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Beata Iskold
6Merck & Co., Inc., Kenilworth, United States of America
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Stuart Green
6Merck & Co., Inc., Kenilworth, United States of America
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Carmen La Rosa
6Merck & Co., Inc., Kenilworth, United States of America
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David Muccino
6Merck & Co., Inc., Kenilworth, United States of America
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Jaclyn Smith
7University of Manchester and Manchester University NHS Trust, Manchester, United Kingdom
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Abstract

Background: COUGH-1 (NCT03449134) and COUGH-2 (NCT03449147) are double-blind, randomized placebo-controlled, Phase 3 trials of gefapixant, a P2X3 receptor antagonist, for refractory or unexplained chronic cough (RCC/UCC).

Methods: Participants were ≥18 yrs, had chronic cough ≥ 1 yr, an RCC/UCC diagnosis, and a screening and baseline cough severity VAS score ≥40 mm; they were randomized to placebo (pbo), gefapixant 15 mg BID, or gefapixant 45 mg BID. Primary endpoints were 24h cough frequency at 12 Wks (COUGH-1) and 24 Wks (COUGH-2) (analyzed with longitudinal ANCOVA based on log-transformed data).

Results: A total of 2,044 participants (75% female, mean age 58 yrs, mean cough duration 11 yrs) were randomized/treated in COUGH-1 (n=730) and COUGH-2 (n=1314). Despite a larger-than-anticipated pbo response, gefapixant 45 mg demonstrated significant reduction in 24h cough frequency vs. pbo in both trials. The 15 mg dose failed to demonstrate a reduction in cough frequency vs. pbo. Overall adverse events (AE) and taste-related AEs occurred at higher incidence with 45 mg vs. pbo or 15 mg; serious-AE incidence was similar between treatments (Table).

Conclusions: Treatment with gefapixant 45 mg BID resulted in significant reduction in 24h cough frequency in participants with RCC/UCC. Serious AEs were infrequent and AEs with gefapixant 45 mg were most commonly related to taste.

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Footnotes

Cite this article as: European Respiratory Journal 2020; 56: Suppl. 64, 3800.

This abstract was presented at the 2020 ERS International Congress, in session “Respiratory viruses in the "pre COVID-19" era”.

This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).

  • Copyright ©the authors 2020
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Late Breaking Abstract - Two Phase 3 Randomized Clinical Trials of Gefapixant, a P2X3 Receptor Antagonist, in Refractory or Unexplained Chronic Cough (COUGH-1 and COUGH-2)
Lorcan McGarvey, Surinder Birring, Alyn Morice, Peter Dicpinigaitis, Ian Pavord, Jonathan Schelfhout, Allison Martin Nguyen, Qing Li, Anjela Tzontcheva, Beata Iskold, Stuart Green, Carmen La Rosa, David Muccino, Jaclyn Smith
European Respiratory Journal Sep 2020, 56 (suppl 64) 3800; DOI: 10.1183/13993003.congress-2020.3800

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Late Breaking Abstract - Two Phase 3 Randomized Clinical Trials of Gefapixant, a P2X3 Receptor Antagonist, in Refractory or Unexplained Chronic Cough (COUGH-1 and COUGH-2)
Lorcan McGarvey, Surinder Birring, Alyn Morice, Peter Dicpinigaitis, Ian Pavord, Jonathan Schelfhout, Allison Martin Nguyen, Qing Li, Anjela Tzontcheva, Beata Iskold, Stuart Green, Carmen La Rosa, David Muccino, Jaclyn Smith
European Respiratory Journal Sep 2020, 56 (suppl 64) 3800; DOI: 10.1183/13993003.congress-2020.3800
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