Evidence map›Paper›PMID 33263037›Full record

ArticleERJ open research2020

Design and rationale of two phase 3 randomised controlled trials (COUGH-1 and COUGH-2) of gefapixant, a P2X3 receptor antagonist, in refractory or unexplained chronic cough.

David R Muccino, Alyn H Morice, Surinder S Birring, Peter V Dicpinigaitis, Ian D Pavord, Christopher Assaid, Huub Jan Kleijn, Azher Hussain, Carmen La Rosa, Lorcan McGarvey and 1 more

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in ERJ open research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 36 papers.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed
5.8field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03449134 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Month Study to Evaluate the Efficacy and Safety of MK-7264 in Adult Participants With Chronic Cough (PN027)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2018 to 2020Enrolled732ConditionsChronic CoughArmsPlacebo, Gefapixant
NCT03449147 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Month Study to Evaluate the Efficacy and Safety of MK-7264 in Adult Participants With Chronic Cough (PN030)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2018 to 2020Enrolled1,317ConditionsChronic CoughArmsPlacebo, Gefapixant 15 mg BID, Gefapixant 45 mg BID
3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 53 citations in OpenAlex.

  1. Trial
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  5. Article
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  7. Review
  8. Article
  9. Cough in idiopathic pulmonary fibrosis: what is new.Breathe (Sheffield, England) · 2025
    Article
  10. Article
  11. Article
  12. Review
  13. Review
  14. Article
  15. Article
  16. Article
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  18. Efficacy and Safety of Gefapixant for Refractory or Unexplained Chronic Cough over 52 Weeks.American journal of respiratory and critical care medicine · 2023
    Article
  19. Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 8 institutions in 3 countries.

David R MuccinoMerck & Co., Inc., Kenilworth, NJ, USA.
Alyn H MoriceHull York Medical School, Cottingham, UK.
Surinder S BirringCentre for Human and Applied Physiological Sciences, School of Basic and Medical Biosciences, King's College London, London, UK.
Peter V DicpinigaitisAlbert Einstein College of Medicine and Montefiore Medical Center, Bronx, NY, USA.
Ian D PavordOxford NIHR Respiratory BRC, Nuffield Dept of Medicine, University of Oxford, Oxford, UK.
Christopher AssaidMerck & Co., Inc., Kenilworth, NJ, USA.
Huub Jan KleijnCertara Strategic Consulting, Oss, The Netherlands.
Azher HussainMerck & Co., Inc., Kenilworth, NJ, USA.
Carmen La RosaMerck & Co., Inc., Kenilworth, NJ, USA.
Lorcan McGarveyWellcome-Wolfson Institute of Experimental Medicine, Queen's University Belfast, Belfast, UK.
Jaclyn A SmithDivision of Infection, Immunity and Respiratory Medicine, University of Manchester and Manchester University NHS Trust, Manchester, UK.ORCID https://orcid.org/0000-0001-8837-4928
Merck & Co., Inc., Rahway, NJ, USA (United States) · USAlbert Einstein College of Medicine · USHull York Medical School · GBKing's College London · GBManchester University NHS Foundation Trust · GBQueen's University Belfast · GBThe Hague Centre for Strategic Studies · NLUniversity of Oxford · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe present study designs, dose selection and preliminary patient characteristics from two phase 3 clinical trials of gefapixant, a P2X3 receptor antagonist, in refractory chronic cough (RCC) or unexplained chronic cough (UCC).

methodsCOUGH-1 (NCT03449134) and COUGH-2 (NCT03449147) are randomised, placebo-controlled, double-blind, parallel-group trials in subjects with RCC or UCC (age ≥18 years; cough duration ≥1 year; Cough Severity Visual Analogue Scale score ≥40 mm). The primary efficacy study periods are 12 weeks (40-week extension; COUGH-1) and 24 weeks (28-week extension; COUGH-2). Interventions include placebo, gefapixant 15 mg and gefapixant 45 mg (1:1:1 ratio). The primary efficacy endpoints are average 24-h cough frequency at Week 12 (COUGH-1) and Week 24 (COUGH-2). Awake cough frequency, patient-reported outcomes and responder analyses are secondary endpoints.

resultsThe doses of 45 mg (to provide maximal efficacy and acceptable tolerability) and 15 mg (to provide acceptable efficacy and improved tolerability) were selected based on phase 1 and 2 studies. In COUGH-1, 730 participants have been randomised and treated; 74% are female with mean age of 59 years (39% over 65 years), and mean baseline duration of cough of 11.5 years. In COUGH-2, 1314 participants have been randomised and treated; 75% are female with mean age of 58 years (33% over 65 years), and mean baseline duration of cough of 11.1 years.

conclusionsThese global studies include participants with baseline characteristics consistent with previous RCC and UCC studies and will inform the efficacy and safety profile of gefapixant in the treatment of patients with RCC and UCC.

Identifiers

PMID33263037
PMCPMC7682670
OpenAlexW3096839459

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.