Efficacy and safety of AX-8 in patients with chronic cough.
Research type
Research Study
Full title
A multi-centre, randomised, placebo and active-controlled, double-blind, cross-over, phase IIa proof-of-concept trial to investigate the efficacy and safety of AX-8 Tablets 5 mg in patients with chronic refractory cough and associated upper airway symptoms
IRAS ID
210459
Contact name
Alyn Morice
Contact email
Sponsor organisation
Hull and East Yorkshire Hospitals NHS Trust
Eudract number
2016-004803-30
Duration of Study in the UK
0 years, 10 months, 1 days
Research summary
This is a multi-centre, randomised, placebo and active-controlled, double-blind, cross-over, phase 2a proof-of-concept trial to investigate the efficacy and safety of AX-8 5mg tablets in patients with chronic refractory cough and associated upper airway symptoms.
The trial comprises six visits within 4 weeks: Screening Visit (V1), Baseline Visit (V2), Treatment Visit 1 (V3), Treatment Visit 2 (V4), Treatment Visit 3 (V5) and Follow-Up Visit (V6).
All patients will receive three investigational medicinal products (5mg AX-8, 5mg menthol and placebo). On the Treatment Visit days V3, V4 and V5, one dose of IMP (AX-8, menthol or placebo) will be administered.
The main objectives are to study the efficacy and safety of 5mg AX-8 tablets in suppressing cough and upper airway symptoms in patients with chronic refractory cough and associated upper airway symptoms when compared to 5mg menthol and placebo.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
17/YH/0008
Date of REC Opinion
31 Mar 2017
REC opinion
Further Information Favourable Opinion