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

Aldeyra Therapeutics

Status and phase: Completed; Phase 2

Conditions: Chronic Cough

Treatments: Drug: Placebo; Drug: ADX-629

Study type: Interventional

Funder types: Industry

Identifiers

NCT05392192

ADX-629-CC-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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51 participants in 2 patient groups, including a placebo group

ADX-629

Experimental group

Description:

Subjects will be randomized to receive ADX-629 300mg tablets administered orally twice a day for 14 days.

Treatment:

Drug: ADX-629

Placebo

Placebo Comparator group

Description:

Subjects will be randomized to receive matching placebo tablets administered orally twice a day for 14 days.

Treatment:

Drug: Placebo