Clinical trial NCT05392192: A Clinical Trial to Evaluate the Safety and Efficacy in Subjects With Chronic Cough
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Cough
Keywords: refractory cough
cough hypersensitivity
ADX-629
unexplained cough
reactive aldehyde species
crossover
inflammation
Lead sponsor: Aldeyra Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-26
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Subjects With Serious Adverse Events
timeFrame: The safety assessment period was Day 1 - Day 14 for each treatment period.
Secondary outcomes:
measure: Change From Baseline in Awake Cough Frequency Per Hour With Prior Treatment as a Factor
timeFrame: The efficacy assessment period was Day 14 for each treatment period. Baseline was Day 1 prior to dosing for each treatment period.
measure: Change From Baseline in 24-hour Cough Frequency Per Hour With Prior Treatment as a Factor
timeFrame: The efficacy assessment period was Day 14 for each treatment period. Baseline was Day 1 prior to dosing for each treatment period.
measure: Change From Baseline in Awake Cough Frequency Per Hour for Period 1
timeFrame: The efficacy assessment period was Day 14. Baseline was Day 1 for Period 1.
measure: Change From Baseline in 24-hour Cough Frequency Per Hour for Period 1
timeFrame: The efficacy assessment period was Day 14. Baseline was Day 1 for Period 1.
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Allergy Associates Medical Group, Inc.
state: California
city: San Jose
country: United States
facility: Allergy & Asthma Associates of Santa Clara Valley Research Center
state: California
city: Hollywood
country: United States
facility: Cano Research - Hollywood
state: Florida
city: Loxahatchee Groves
country: United States
facility: Advanced Pulmonary Research Institute
state: Florida
city: Winter Park
country: United States
facility: Florida Pulmonary Research Institute LLC
state: Florida
city: Columbus
country: United States
facility: ClinCept
state: Georgia
city: Rochester
country: United States
facility: Mayo Clinic Pulmonary Clinic Research Unit
state: Minnesota
city: New York
country: United States
facility: Mount Sinai
state: New York
city: Charlotte
country: United States
facility: Charlotte Lung & Health/American Health Research
state: North Carolina
city: Cincinnati
country: United States
facility: Bernstein Clinical Research Center, LLC
state: Ohio
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research
state: Oklahoma
city: Portland
country: United States
facility: Northwest Research Center
state: Oregon
city: Rock Hill
country: United States
facility: Clinical Research of Rock Hill
state: South Carolina
city: Dallas
country: United States
facility: Pharmaceutical Research and Consulting Inc.
state: Texas
Study officials:
References: