Gefapixant in two randomised dose-escalation studies in chronic cough

Research output: Contribution to journalArticlepeer-review

  • External authors:
  • Michael M Kitt
  • Peter Butera
  • Steven A Smith
  • Yuping Li
  • Zhi Jin Xu
  • Shilpi Sen
  • Mandel R Sher
  • Anthony P Ford

Abstract

BACKGROUND Gefapixant has previously demonstrated efficacy in the treatment refractory chronic cough at a high, daily dose. OBJECTIVES The current investigations explore efficacy and tolerability of gefapixant, a P2X3 receptor antagonist, for the treatment of chronic cough using a dose escalation approach. MATERIALS AND METHODS Two randomised, double-blind, placebo-controlled, crossover, dose-escalation studies recruited participants with refractory chronic cough. Patients were assigned to receive ascending doses of gefapixant (study 1: 50-200 mg, study 2: 7.5-50 mg) or placebo for 16 days, then crossed-over after washout. The primary endpoint was awake cough frequency assessed using a 24 h ambulatory cough monitor at baseline and on day 4 of each dose. Patient reported outcomes included a cough severity visual analogue scale (VAS) and Cough Severity Diary (CSD). RESULTS In clinical studies, gefapixant doses ≥30 mg produced maximal improvements in cough frequency compared with placebo (p

Bibliographical metadata

Original languageEnglish
JournalEuropean Respiratory Journal
Early online date16 Jan 2020
DOIs
Publication statusPublished - 16 Jan 2020