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)

2020 ◽  
Author(s):  
Lorcan McGarvey ◽  
Surinder Birring ◽  
Alyn Morice ◽  
Peter Dicpinigaitis ◽  
Ian Pavord ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Receptor Antagonist ◽  
Chronic Cough ◽  
Randomized Clinical Trials ◽  
P2x3 Receptor ◽  
Phase 3 ◽  
Two Phase

scholarly journals TREATMENT OF REFRACTORY OR UNEXPLAINED CHRONIC COUGH WITH GEFAPIXANT, A P2X3 RECEPTOR ANTAGONIST, OVER 52 WEEKS IN TWO PHASE III CLINICAL TRIALS

CHEST Journal ◽  
2021 ◽  
Vol 160 (4) ◽  
pp. A2361-A2362
Author(s):  
Peter Dicpinigaitis ◽  
Surinder Birring ◽  
Alyn Morice ◽  
Jaclyn Smith ◽  
Lorcan McGarvey ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Receptor Antagonist ◽  
Chronic Cough ◽  
Phase Iii ◽  
P2x3 Receptor ◽  
Two Phase ◽  
Phase Iii Clinical Trials

scholarly journals 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

2020 ◽  
Vol 6 (4) ◽  
pp. 00284-2020
Author(s):  
David R. Muccino ◽  
Alyn H. Morice ◽  
Surinder S. Birring ◽  
Peter V. Dicpinigaitis ◽  
Ian D. Pavord ◽  
...  
Keyword(s):  
Receptor Antagonist ◽  
Chronic Cough ◽  
Phase 1 ◽  
Primary Efficacy ◽  
P2x3 Receptor ◽  
Phase 3 ◽  
Two Phase ◽  
Link Type ◽  
Cough Frequency ◽  
Patient Reported

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.

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