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The effect of gefapixant, a P2X3 antagonist, on cough reflex sensitivity: A randomised placebo-controlled study

Morice, Alyn H.; Kitt, Michael M.; Ford, Anthony P.; Tershakovec, Andrew M.; Wu, Wen Chi; Brindle, Kayleigh; Thompson, Rachel; Thackray-Nocera, Susannah; Wright, Caroline

Authors

Michael M. Kitt

Anthony P. Ford

Andrew M. Tershakovec

Wen Chi Wu

Kayleigh Brindle

Rachel Thompson

Susannah Thackray-Nocera

Caroline Wright



Abstract

We evaluated the effect of gefapixant on cough reflex sensitivity to evoked tussive challenge.

In this phase 2, double-blind, two-period study, patients with chronic cough (CC) and healthy volunteers (HV) were randomised to single-dose gefapixant 100 mg or placebo in a crossover fashion. Sequential inhalational challenges with ATP, citric acid, capsaicin and distilled water were performed 1, 3 and 5 h after dosing. Mean concentrations evoking ≥2 coughs (C2) and ≥5 coughs (C5) post dose versus baseline were co-primary endpoints. Objective cough frequency (coughs·h−1) over 24 h and a cough severity visual analogue scale (VAS) were assessed in CC patients. Adverse events were monitored.

24 CC patients and 12 HV were randomised (mean age 61 and 38 years, respectively). The cough challenge threshold increased for ATP by 4.7-fold (C2, p≤0.001) and 3.7-fold (C5, p=0.007) for gefapixant versus placebo in CC patients; in HV, C2 and C5 increased 2.4-fold (C2, p=0.113; C5, p=0.003). The distilled water C2 and C5 thresholds increased significantly (p

Citation

Morice, A. H., Kitt, M. M., Ford, A. P., Tershakovec, A. M., Wu, W. C., Brindle, K., …Wright, C. (2019). The effect of gefapixant, a P2X3 antagonist, on cough reflex sensitivity: A randomised placebo-controlled study. European respiratory journal, 54(1), Article 1900439. https://doi.org/10.1183/13993003.00439-2019

Journal Article Type Article
Acceptance Date Apr 3, 2019
Online Publication Date Jul 4, 2019
Publication Date Jul 4, 2019
Deposit Date May 23, 2019
Publicly Available Date Jul 5, 2020
Journal European Respiratory Journal
Print ISSN 0903-1936
Electronic ISSN 1399-3003
Publisher European Respiratory Society
Peer Reviewed Peer Reviewed
Volume 54
Issue 1
Article Number 1900439
DOI https://doi.org/10.1183/13993003.00439-2019
Keywords Pulmonary and Respiratory Medicine
Public URL https://hull-repository.worktribe.com/output/1835195
Publisher URL https://erj.ersjournals.com/content/54/1/1900439

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