A Phase 2 Study of Efficacy and Safety of AX-8 in Chronic Cough
A Phase 2 Study to Assess the Efficacy and Safety of AX-8 in Patients with Chronic Cough
Duration of Study in the UK
0 years, 8 months, 2 days
This study is designed for patients with refractory chronic cough (RCC) and unexplained chronic cough (UCC), i.e., a cough lasting more than 8 weeks (i.e., chronic) that persist despite treatment of the underlying conditions (e.g., rhinitis, asthma, post-nasal drip and gastro-oesophageal reflux) (i.e., refractory, RCC) or with no identified co-morbidities/causes (i.e., unexplained, UCC).
The investigational drug AX-8 is expected to reduce cough in conditions where sensory nerves are more sensitive, as may be the case in RCC/UCC.
AX-8 or matching placebo will be administered in the form of an orally disintegrating tablet (ODT), the study drug.
It is anticipated that approximately 50 male and female patients ≥18 and ≤80 years of age will be included in the study across approximately 10 centers in UK. Subjects will be randomly assigned (1:1 ratio) to one of two treatment sequences:
(1) AX-8 for 14 days, followed by a Washout Period, followed by placebo for 14 days; OR
(2) placebo for 14 days, followed by a Washout Period, followed by AX-8 for 14 days.
Study drug will be taken twice daily, once in the morning (AM dose, Dose 1) and once in the afternoon (PM dose, Dose 2), approximately 8 hours apart.
Subject participation is expected to be approximately 10 weeks including Screening, Baseline, Treatment, Washout, and Follow-Up Periods, as follows:
• Screening Period: up to 20 days
• Baseline Treatment Period 1: 1 day
• Treatment Period 1 (AX-8 or Placebo): 14 days
• Washout Period: 7 days (+ 3 days)
• Baseline Treatment Period 2: 1 day
• Treatment Period 2 (Placebo or AX-8): 14 days
• Follow-Up Period: 14 days (± 3 days)
North West - Liverpool Central Research Ethics Committee
Date of REC Opinion
14 Jun 2021
Further Information Favourable Opinion