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

  • STATUS
    Recruiting
  • End date
    Mar 25, 2023
  • participants needed
    50
  • sponsor
    Axalbion SA
Updated on 25 July 2022

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.

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

Eligibility

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?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

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.

Learn more

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

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note