A Clinical Trial to Evaluate the Safety and Efficacy in Subjects With Chronic Cough
- Registration Number
- NCT05392192
- Lead Sponsor
- Aldeyra Therapeutics, Inc.
- 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
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- 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 Subjects With Serious Adverse Events The safety assessment period was Day 1 - Day 14 for each treatment period. Safety was assessed through serious adverse event collection.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Awake Cough Frequency Per Hour With Prior Treatment as a Factor 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 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.
Change From Baseline in 24-hour Cough Frequency Per Hour With Prior Treatment as a Factor 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 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.
Change From Baseline in Awake Cough Frequency Per Hour for Period 1 The efficacy assessment period was Day 14. Baseline was Day 1 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.
Change From Baseline in 24-hour Cough Frequency Per Hour for Period 1 The efficacy assessment period was Day 14. Baseline was Day 1 for Period 1. Change from baseline in cough count in Period 1 was assessed for twenty-four hours 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.
Trial Locations
- 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