A Clinical Trial to Evaluate the Safety and Efficacy in Subjects With Chronic Cough
Completed · Phase 2 · Has a placebo group
Conditions studied: Chronic Cough
In brief
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
Key facts
- Study ID
- NCT05392192
- Run by
- Aldeyra Therapeutics, Inc.
- People needed
- 51
- Starts
- 2022-04-07
- Expected to finish
- 2023-04-13
- Last updated by the study team
- 2025-02-28
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Allergy Associates Medical Group, Inc. — San Diego, California, United States
- Allergy & Asthma Associates of Santa Clara Valley Research Center — San Jose, California, United States
- Cano Research - Hollywood — Hollywood, Florida, United States
- Advanced Pulmonary Research Institute — Loxahatchee Groves, Florida, United States
- Florida Pulmonary Research Institute LLC — Winter Park, Florida, United States
- ClinCept — Columbus, Georgia, United States
- Mayo Clinic Pulmonary Clinic Research Unit — Rochester, Minnesota, United States
- Mount Sinai — New York, New York, United States
- Charlotte Lung & Health/American Health Research — Charlotte, North Carolina, United States
- Bernstein Clinical Research Center, LLC — Cincinnati, Ohio, United States
- Vital Prospects Clinical Research — Tulsa, Oklahoma, United States
- Northwest Research Center — Portland, Oregon, United States
- Clinical Research of Rock Hill — Rock Hill, South Carolina, United States
- Pharmaceutical Research and Consulting Inc. — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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