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

Launched by AXALBION SA · Apr 26, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called AX-8 to see if it can help reduce the frequency of chronic cough in people who have had this issue for a long time. Chronic cough can be frustrating and difficult to manage, especially when the cause is unclear. The trial is looking for participants aged 18 to 74 who have been diagnosed with unexplained chronic cough or refractory chronic cough (which means their cough hasn’t improved despite treatment). To be eligible, participants must have had tests that show no significant problems in their lungs, and they must agree to use reliable contraception if they are capable of becoming pregnant.

During the study, participants will be randomly assigned to receive either AX-8 or a placebo (which looks like the medication but has no active ingredients) for a period of time, and then they will switch to the other treatment. This means that everyone will have a chance to try both treatments. Participants will be closely monitored to evaluate how well the medication works and if there are any side effects. It’s important to note that individuals with certain health conditions, such as recent respiratory infections or a history of smoking, will not be eligible for this trial. Overall, this study aims to find out if AX-8 can provide relief for those suffering from chronic cough.

Gender

ALL

Eligibility 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