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

Phase 2

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
ADX-629	ADX-629	Subjects will be randomized to receive ADX-629 300mg tablets administered orally twice a day for 14 days.
Placebo	Placebo	Subjects will be randomized to receive matching placebo tablets administered orally twice a day for 14 days.

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events (AEs)	From Baseline to the end of each 14-day treatment period (Day 1 - 14 of each treatment period)	Collection of AEs

Secondary Outcome Measures

Name	Time	Method
Change from baseline in awake cough frequency after 2-week treatment period	Day 1 - 14 of each treatment period	Assessed using an ambulatory cough monitor

Locations (14): Mount Sinai
🇺🇸
New York, New York, United States
Cano Research - Hollywood
🇺🇸
Hollywood, Florida, United States
ClinCept
🇺🇸
Columbus, Georgia, United States
Vital Prospects Clinical Research
🇺🇸
Tulsa, Oklahoma, United States
Clinical Research of Rock Hill
🇺🇸
Rock Hill, South Carolina, United States
Charlotte Lung & Health/American Health Research
🇺🇸
Charlotte, North Carolina, United States
Florida Pulmonary Research Institute LLC
🇺🇸
Winter Park, Florida, United States
Allergy & Asthma Associates of Santa Clara Valley Research Center
🇺🇸
San Jose, California, United States
Advanced Pulmonary Research Institute
🇺🇸
Loxahatchee Groves, Florida, United States
Allergy Associates Medical Group, Inc.
🇺🇸
San Diego, California, United States
Mayo Clinic Pulmonary Clinic Research Unit
🇺🇸
Rochester, Minnesota, United States
Bernstein Clinical Research Center, LLC
🇺🇸
Cincinnati, Ohio, United States
Northwest Research Center
🇺🇸
Portland, Oregon, United States
Pharmaceutical Research and Consulting Inc.
🇺🇸
Dallas, Texas, United States