A Clinical Trial to Evaluate the Safety and Efficacy in Subjects With Chronic Cough

Study Overview
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Brief Summary
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A Randomized, Double-Blind, Placebo-Controlled, Two-Period Crossover, Phase 2 Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of ADX-629 Administered Orally to Subjects with Chronic Cough

Detailed Description
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A Phase 2, multicenter, randomized, double-blind, placebo controlled, two-period crossover trial to evaluate the safety, tolerability, and efficacy of ADX-629 (300 mg) administered orally, twice-a-day to eligible participants with refractory or unexplained chronic cough. Patients who are interested in participating will be provided detailed information about the study including description of study assessments/procedures, possible side-effects, alternative treatments, and potential benefits.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Two-Period Crossover, Phase 2 Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of ADX-629 Administered Orally to Subjects With Chronic Cough

Conditions
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Chronic Cough

Intervention / Treatment
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* Drug: ADX-629
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults ≥18 to ≤80 years of age History of refractory or unexplained chronic cough Historical Chest radiograph or CT scan that does not demonstrate any abnormality considered to be significantly contributing to chronic cough Not pregnant, breastfeeding, or lactating and agree to use a highly effective method of acceptable contraceptive for the trial duration, if applicable Agree to discontinue antitussive medications for the trial duration Exclusion Criteria: Current smoker (including cannabis products) or previous smoker having recently given up smoking or has a history of smoking of >20 pack-years History of significant cardiovascular disease or any clinically significant abnormalities in rhythm or conduction History or presence of significant hepatic disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. History of any malignancy within 5 years of screening except for basal cell or squamous cell in situ skin carcinomas or carcinoma in situ of the cervix that has been treated with no evidence of recurrence. Recent history of drug or alcohol abuse or a positive urine drug test at screening Positive serology test for Hepatitis B virus (HBV), Hepatitis C virus (HCV), or HIV-1 and HIV-2 Currently taking an angiotensin converting enzyme inhibitor (ACEI) or has used an ACEI within 3 months of Screening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADX-629<br>Subjects will be randomized to receive ADX-629 300mg tablets administered orally twice a day for 14 days. | Drug: ADX-629<br>* Subjects will be randomized to receive both ADX-629 and placebo in one of two treatment sequences: One group of subjects will receive ADX-629 during the 1st treatment period and matching placebo during the 2nd Treatment while subjects the other sequence/group will receive the matching placebo in the 1st treatment period and ADX-629 in the 2nd treatment period.<br>|
| Placebo Comparator: Placebo<br>Subjects will be randomized to receive matching placebo tablets administered orally twice a day for 14 days. | Drug: Placebo<br>* Subjects will be randomized to receive both ADX-629 and placebo in one of two treatment sequences: One group of subjects will receive ADX-629 during the 1st treatment period and matching placebo during the 2nd Treatment while subjects the other sequence/group will receive the matching placebo in the 1st treatment period and ADX-629 in the 2nd treatment period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events (AEs) | Collection of AEs | From Baseline to the end of each 14-day treatment period (Day 1 - 14 of each treatment period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in awake cough frequency after 2-week treatment period | Assessed using an ambulatory cough monitor | Day 1 - 14 of each treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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refractory cough, cough hypersensitivity, ADX-629, unexplained cough, reactive aldehyde species, crossover, inflammation