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

  • End date
    Mar 25, 2023
  • participants needed
  • sponsor
    Axalbion SA
Updated on 25 July 2022


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.

Condition Chronic Cough
Treatment Placebo, AX-8
Clinical Study IdentifierNCT04866563
SponsorAxalbion SA
Last Modified on25 July 2022


Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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