Evidence map›Paper›PMID 35969360›Full record

ArticlePulmonary therapy2022

Treatment with the P2X3-Receptor Antagonist Gefapixant for Acute Cough in Induced Viral Upper Respiratory Tract Infection: A Phase 2a, Randomized, Placebo-Controlled Trial.

Jaclyn A Smith, Michael M Kitt, Alan Bell, Nicolas Noulin, Anjela Tzontcheva, Megan McGratty Seng, Susan Lu

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Pulmonary therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03569033 (A Phase 2a, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of MK-7264 on Acute Cough in Participants With Induced Viral Upper Respiratory Tract Infection), which is not on this map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
0.8field-weighted citation impact, top 28% 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.

NCT03569033 phase2terminatednot on this map

A Phase 2a, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of MK-7264 on Acute Cough in Participants With Induced Viral Upper Respiratory Tract Infection

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2018 to 2018Enrolled46ConditionsAcute CoughArmsGefapixant, Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 2 syntheses or guidelines pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Efficacy and safety of gefapixant for chronic cough: a meta-analysis of randomised controlled trials.European respiratory review : an official journal of the European Respiratory Society · 2023
    Pooled it
  3. Review
  4. Review
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

7 authors at 3 institutions in 2 countries.

Jaclyn A SmithDivision of Infection, Immunity & Respiratory Medicine, 2nd Floor Education & Research Centre, University of Manchester, Manchester University NHS Foundation Trust, Southmoor Rd, Wythenshawe, M23 9LT, Manchester, UK. Jacky.Smith@manchester.ac.uk.
Michael M KittAxalbion Therapeutics Limited, Manchester, UK.
Alan BellhVIVO, a subsidiary of Open Orphan Plc, London, UK.
Nicolas NoulinhVIVO, a subsidiary of Open Orphan Plc, London, UK.
Anjela TzontchevaMerck & Co., Inc., Rahway, NJ, USA.
Megan McGratty SengMerck & Co., Inc., Rahway, NJ, USA.
Susan LuMerck & Co., Inc., Rahway, NJ, USA.
Merck & Co., Inc., Rahway, NJ, USA (United States) · UShVIVO (United Kingdom) · GBManchester University NHS Foundation Trust · GB

Funding

Wellcome Trust
6 · The paper itself

Abstract

introductionAvailable therapies for acute cough, a condition frequently caused by a viral upper respiratory tract infection (URTI), have shown limited evidence of efficacy. Gefapixant, a P2X3-receptor antagonist, has demonstrated efficacy and safety in studies of the treatment of refractory or unexplained chronic cough, but its efficacy for treating acute cough has not been previously studied.

methodsThis was a phase 2a, randomized, double-blind, placebo-controlled, parallel-group, pilot study. Healthy volunteers were randomized 1:1 to receive twice-daily gefapixant 45 mg or placebo and inoculated with human rhinovirus 16 to induce URTI and cough. Participants were observed while quarantined for 7 days after the start of treatment. The primary endpoint was awake cough frequency on day 3, which was objectively measured with a cough-recording device. Secondary endpoints included change from baseline to day 3 in subjective cough severity measures (cough severity visual analog scale, Cough Severity Diary) and cough-specific quality of life (Leicester Cough Questionnaire-acute).

resultsOf the 46 participants who met inclusion criteria [mean (standard deviation, SD) age, 24.6 (6.5) years; females, n = 8], 40 completed the study (gefapixant, n = 21; placebo, n = 19). There was no significant difference in awake cough frequency on day 3 between the gefapixant and placebo groups [least squares means, 2.4 versus 2.7 coughs per hour, respectively; mean difference (95% confidence interval, CI), -0.3 (-2.3, 1.7); P = 0.75]. There were no significant between-group differences for any of the secondary endpoints. Peak cough frequency was low and occurred later in the study than expected (days 4-5). The safety profile was consistent with that of previous studies of gefapixant.

conclusionCompared with placebo, gefapixant did not reduce the frequency or severity of acute cough secondary to induced URTI. Induced viral URTI produced mild symptoms, including lower cough frequency than observed in previous studies of patients selected for acute cough associated with naturally occurring URTI.

trial registrationClinicalTrials.gov, NCT03569033; EudraCT, 2017-000472-28; protocol number, MK-7264-013.

Indexed as

Acute coughAntitussivesCommon coldCough frequencyP2X3-receptor antagonistsURTI

Identifiers

PMID35969360
PMCPMC9458823
OpenAlexW4291492793

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.