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.
ERJ Open Res
; 6(4)2020 Oct.
Article
em En
| MEDLINE
| ID: mdl-33263037
ABSTRACT
BACKGROUND:
We 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).METHODS:
COUGH-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 ≥40â mm). The primary efficacy study periods are 12â weeks (40-week extension; COUGH-1) and 24â weeks (28-week extension; COUGH-2). Interventions include placebo, gefapixant 15â mg and gefapixant 45â mg (111 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.RESULTS:
The doses of 45â mg (to provide maximal efficacy and acceptable tolerability) and 15â 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.CONCLUSIONS:
These 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.
Texto completo:
1
Bases de dados:
MEDLINE
Tipo de estudo:
Clinical_trials
Idioma:
En
Revista:
ERJ Open Res
Ano de publicação:
2020
Tipo de documento:
Article
País de afiliação:
Estados Unidos