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

Chronic Cough Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05392192
• Other study ID #: ADX-629-CC-001
• Status: Completed
• Phase: Phase 2
• Start date: April 7, 2022
• Est. completion date: April 13, 2023

Study information

• Verified date: July 2022
• Source: Aldeyra Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: April 13, 2023
• Est. primary completion date: April 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Cough
• Cough

Intervention

Drug:
• ADX-629
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.
• Placebo
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.

Locations

Country	Name	City	State
United States	Charlotte Lung & Health/American Health Research	Charlotte	North Carolina
United States	Bernstein Clinical Research Center, LLC	Cincinnati	Ohio
United States	ClinCept	Columbus	Georgia
United States	Pharmaceutical Research and Consulting Inc.	Dallas	Texas
United States	Cano Research - Hollywood	Hollywood	Florida
United States	Advanced Pulmonary Research Institute	Loxahatchee Groves	Florida
United States	Mount Sinai	New York	New York
United States	Northwest Research Center	Portland	Oregon
United States	Mayo Clinic Pulmonary Clinic Research Unit	Rochester	Minnesota
United States	Clinical Research of Rock Hill	Rock Hill	South Carolina
United States	Allergy Associates Medical Group, Inc.	San Diego	California
United States	Allergy & Asthma Associates of Santa Clara Valley Research Center	San Jose	California
United States	Vital Prospects Clinical Research	Tulsa	Oklahoma
United States	Florida Pulmonary Research Institute LLC	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Aldeyra Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events (AEs)	Collection of AEs	From Baseline to the end of each 14-day treatment period (Day 1 - 14 of each treatment period)
Secondary	Change from baseline in awake cough frequency after 2-week treatment period	Assessed using an ambulatory cough monitor	Day 1 - 14 of each treatment period