A pilot study of efficacy, safety and tolerability of AX-8 in cough
Research type
Research Study
Full title
A PILOT STUDY OF THE EFFICACY, SAFETY, AND TOLERABILITY OF AX-8 FOR THE TREATMENT OF REFRACTORY CHRONIC COUGH.
IRAS ID
232939
Contact name
Jacky Smith
Contact email
Sponsor organisation
Axalbion SA
Eudract number
2017-003108-27
Duration of Study in the UK
1 years, 3 months, 5 days
Research summary
This is an open-label pilot study of the efficacy, safety and tolerability of AX-8 for the treatment of Refractory Chronic Cough (RCC). The study was designed to allow for planning of a future randomised, controlled clinical study in patients diagnosed with RCC.
Approximately 10-15 subjects who meet entry criteria will be assigned to a single dose (5mg) of AX-8, which is an orally disintegrating tablet (ODT). The primary objective of the trial is to assess the effectiveness of AX-8 for the treatment of RCC and associated upper airway symptoms after one dose of treatment in reducing awake cough frequency compared to baseline. Objective cough frequency will be measured as 24-hour sound recordings using a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
17/YH/0313
Date of REC Opinion
12 Sep 2017
REC opinion
Favourable Opinion