Study of Serlopitant for the Treatment of Refractory Chronic Cough
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Refractory Chronic Cough
IRAS ID
233211
Contact name
Jaclyn Smith
Contact email
Sponsor organisation
Menlo Therapeutics Incorporated
Eudract number
2017-003250-16
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
135540, IND number
Duration of Study in the UK
0 years, 11 months, 3 days
Research summary
Chronic cough is defined as a cough lasting longer than 8 weeks. Patients who present to a doctor for a persistent cough are evaluated and treated for obvious and common causes of cough. If a patient continues to cough, he/she is evaluated for conditions that are commonly associated with chronic cough such as asthma, gastroesophageal reflux disease, and upper airway cough syndrome. When no underlying cause of their cough can be found they are considered to have “Refractory Chronic Cough”. Patients with refractory chronic cough report that their condition is frequently disabling and has a marked effect on their quality of life. Treatment options for refractory chronic cough are very limited. There are no approved drugs for the treatment of this disease.
Serlopitant has not been studied in patients with refractory chronic cough. However, serlopitant has been studied extensively in other indications. Other drugs that work in a similar way to Selopitant (other NK1-R antagonists such as aprepitant and orvepitant) have reported success in pilot studies in treating chronic cough. This study will explore the effectiveness of serlopitant in subjects with refractory chronic cough.
The study design is a randomized, double-blind, placebo-controlled trial. Approximately 170 subjects will be randomly assigned to serlopitant 5 mg or matching placebo in a 1:1 ratio. Approximately ten NHS hospitals with specialist cough clinics will take part in the study across the UK (and some hospitals in the US).
The study will consist of three periods, for a total study period of approximately 18 weeks:
• Screening period: 14 days
• Treatment period: 84 days
• Follow-up period: 28 daysThe effectiveness of serlopitant in reducing coughing will be measured by recording the number of coughs for 24-hour periods on treatment days 0, 28, 56, 84 and 112, using a sound recording device worn by the subjects.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
17/NW/0584
Date of REC Opinion
16 Nov 2017
REC opinion
Further Information Favourable Opinion