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Evaluating AX-8 for treating chronic cough

A Phase 2 Study to Assess the Efficacy and Safety of AX-8 in Patients with Chronic Cough

Phase 2 Interventional Axalbion SA · NCT04866563

This study is testing a new treatment called AX-8 to see if it can help people with chronic cough feel better compared to a placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment100 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorAxalbion SA Industry-sponsored
Locations16 sites (Birmingham, England and 15 other locations)
Trial IDNCT04866563 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled, crossover study assessing the efficacy and safety of AX-8 in patients suffering from unexplained or refractory chronic cough. Participants will receive either AX-8 or a placebo in two parts of the study, allowing for a direct comparison of the treatment's effectiveness in reducing cough frequency. The study aims to gather data from multiple centers to ensure a diverse participant pool and robust results.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with refractory chronic cough or unexplained chronic cough for at least one year.

Not a fit: Patients with a recent history of smoking or those whose cough is caused by an ACE-inhibitor will likely not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce cough frequency and improve the quality of life for patients with chronic cough.

How similar studies have performed: While this approach is not widely tested, previous studies on chronic cough treatments have shown varying degrees of success, indicating potential for this novel intervention.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Birmingham, England and 15 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Cough
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.