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

Aldeyra Therapeutics, Inc.51 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Chronic Cough

Interventions

ADX-629DRUG

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.

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (14)

Allergy Associates Medical Group, Inc.

San Diego, California, United States

Allergy & Asthma Associates of Santa Clara Valley Research Center

San Jose, California, United States

Outcomes

Primary Outcomes

Number of Subjects With Serious Adverse Events

Safety was assessed through serious adverse event collection.

Time frame: The safety assessment period was Day 1 - Day 14 for each treatment period.

Secondary Outcomes

Change From Baseline in Awake Cough Frequency Per Hour With Prior Treatment as a Factor

Change from baseline in cough count was assessed while subjects were awake using a cough monitor with a digital recording device. The number of coughs is proportional to disease severity. Estimates were obtained using mixed model repeated measures (MMRM) analysis with treatment and prior treatment (none for Period 1; Period 1 treatment for Period 2) as fixed effects, and period-specific baseline as a covariate.

Time frame: The efficacy assessment period was Day 14 for each treatment period. Baseline was Day 1 prior to dosing for each treatment period.

Change From Baseline in 24-hour Cough Frequency Per Hour With Prior Treatment as a Factor

Change from baseline in cough count was assessed for twenty-four hours using a cough monitor with a digital recording device. Number of coughs is associated with disease severity. Estimates were obtained using MMRM analysis with treatment and prior treatment (none for Period 1; Period 1 treatment for Period 2) as fixed effects, and period-specific baseline as a covariate.

Time frame: The efficacy assessment period was Day 14 for each treatment period. Baseline was Day 1 prior to dosing for each treatment period.

Change From Baseline in Awake Cough Frequency Per Hour for Period 1

Change from baseline in cough count in Period 1 was assessed while subjects were awake using a cough monitor with a digital recording device. The number of coughs is proportional to disease severity. Estimates were obtained using MMRM analysis with treatment as fixed effect, and Period 1-specific baseline as a covariate.

Time frame: The efficacy assessment period was Day 14. Baseline was Day 1 for Period 1.

Data from ClinicalTrials.gov

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