Gefapixant Phase 3b Study in Adults with Recent Onset Chronic Cough
Research type
Research Study
Full title
A Phase 3b Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Gefapixant in Adult Participants with Recent Onset Chronic Cough
IRAS ID
273077
Contact name
Alice Turner
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc
Eudract number
2019-002308-42
Duration of Study in the UK
1 years, 4 months, 14 days
Research summary
Research Summary
Chronic cough, defined as a cough lasting >8 weeks, is a common complaint worldwide and one of the most frequent concerns prompting patients to seek a physician consultation. The overall global prevalence of chronic cough is approximately 10%. Given the prolonged nature, significant morbidity, lack of effective treatment, unexplained or refractory chronic cough is a major unmet medical need.
Cough is initiated following activation of airway sensory nerves, mainly C-fibre sensory neurons, in the upper and lower respiratory tract. P2X3 receptors respond to Adenosine Triphosphate (ATP) which is released by damaged, stressed, and inflamed tissues. The drug to be tested in this study is gefapixant (MK-7264) which is a P2X3 receptor antagonist. Gefapixant can bind to the P2X3 receptor, preventing ATP binding and thereby prevent the cough response from occurring.
This study is to evaluate the efficacy and safety of gefapixant in improving cough-specific quality of life in adult participants with recent onset chronic cough. Recent onset chronic cough is defined as duration of >8 weeks after onset of cough symptoms for <12 months prior to the screening visit (i.e. <14 months after the onset of cough symptoms)
In this study, participants will receive treatment twice daily with either MK-7264 (45 mg) or placebo in a 1:1 ratio for a 12-week intervention period. Cough-specific quality of life will be measured as change from baseline in the Leicester Cough Questionnaire total score at week 12.
Approximately 414 participants will take part in the study which will last approximately 18 months. Each participant will be in the study for approximately 16 weeks. The study will take place at 4 sites in the UK and is funded by Merck Sharp & Dohme Limited.
Summary of Results
: https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbRehJ-2Fi4xyo44sEgJVCl5Bdj8o1FpylFwbn362DUDJ-2FzBEKRY7sQFWLU9z8CQB8C-2Fnub1Juv-2FB-2FUqLU3Pyw40V06rOLq2NzaclGlv5Vcih1cMiv6_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YLZ1Gtv-2BEKzmhLjKRibI6UxNz3UPfXS3YNE-2Fo53xEQ5-2BGD9L-2BmKQjgrRs4QuhHaDtidwY-2FYQC1DKy2km2cyWeK1b0HZetHQtecG0Ychpsd-2FZJH3-2BjpSeZyQIraRWvMMkPe7REnCAHRuW86LI21SMHrMAGkmE-2FZ7QyVjYjqDeZSV0g-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C1d9560509c4f4a20ddb708dacbf64681%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638046555845934317%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=hSeetrFp%2FdCfYW5Mom%2FxxhnhFutO39I%2F0V1G15WfFsc%3D&reserved=0
REC name
London - Brent Research Ethics Committee
REC reference
19/LO/1826
Date of REC Opinion
9 Dec 2019
REC opinion
Favourable Opinion