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

NCT ID: NCT05392192

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-07
• Study Completion Date: 2023-04-13

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.

Conditions

Chronic Cough

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ADX-629

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

Group Type: EXPERIMENTAL

ADX-629

Intervention Type: DRUG

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 matching placebo tablets administered orally twice a day for 14 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aldeyra Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Allergy Associates Medical Group, Inc.

San Diego, California, United States

Allergy & Asthma Associates of Santa Clara Valley Research Center

San Jose, California, United States

Cano Research - Hollywood

Hollywood, Florida, United States

Advanced Pulmonary Research Institute

Loxahatchee Groves, Florida, United States

Florida Pulmonary Research Institute LLC

Winter Park, Florida, United States

ClinCept

Columbus, Georgia, United States

Mayo Clinic Pulmonary Clinic Research Unit

Rochester, Minnesota, United States

Mount Sinai

New York, New York, United States

Charlotte Lung & Health/American Health Research

Charlotte, North Carolina, United States

Bernstein Clinical Research Center, LLC

Cincinnati, Ohio, United States

Vital Prospects Clinical Research

Tulsa, Oklahoma, United States

Northwest Research Center

Portland, Oregon, United States

Clinical Research of Rock Hill

Rock Hill, South Carolina, United States

Pharmaceutical Research and Consulting Inc.

Dallas, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ADX-629-CC-001

Identifier Type: -

Identifier Source: org_study_id