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

  • End date
    Dec 12, 2023
  • participants needed
  • sponsor
    Aldeyra Therapeutics, Inc.
Updated on 12 August 2022


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


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.

Condition Chronic Cough
Treatment Placebo, ADX-629
Clinical Study IdentifierNCT05392192
SponsorAldeyra Therapeutics, Inc.
Last Modified on12 August 2022


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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