Overview

A Study of Efficacy and Safety of AX-8 in Chronic Cough

Status:
Recruiting
Trial end date:
2022-04-01
Target enrollment:
0
Participant gender:
All
Summary
This is a randomized, double-blind, placebo-controlled, crossover, multicenter study of AX-8 in participants with unexplained or refractory chronic cough designed to evaluate the effectiveness of AX-8 in reducing cough frequency.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Axalbion SA
Criteria
Inclusion Criteria:

- Chest radiograph or computed tomography (CT) of the thorax approximately 12 months
before screening not demonstrating any abnormality considered to be significantly
contributing to the chronic cough

- Have a diagnosis of refractory chronic cough (RCC) or unexplained chronic cough (UCC)
for at least one year

- Women of childbearing potential and their male partners must use 2 acceptable methods
of contraception

- Male subjects and their female partners of childbearing potential must use 2
acceptable methods of contraception

- Have provided written informed consent

Exclusion Criteria:

- Positive diagnostic nucleic acid test for severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2)

- Current smoker (including e-cigarettes), individuals who have given up smoking within
the past 12 months, or individuals with a smoking history of 20 pack-years

- Treatment with an ACE-inhibitor as the potential cause of a subject's cough or
requiring treatment with an ACE-inhibitor during the study or within 12 weeks prior to
the Baseline Visit

- History of upper or lower respiratory tract infection or recent significant change in
pulmonary status within 4 weeks

- History of cystic fibrosis

- Positive test for any drug of abuse

- History of malignancy within 5 years prior to the Baseline Visit

- History of infection or known active infection with human immunodeficiency (HIV),
hepatitis B virus (HBV), or hepatitis C virus (HCV)

- History of hypersensitivity or intolerance to AX-8 or other TRPM8 agonists or any of
the excipients