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

NCT05392192 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ADX-629-CC-001
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 14

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

Conditions

Chronic Cough

Keywords

refractory cough; cough hypersensitivity; ADX-629; unexplained cough; reactive aldehyde species; crossover; inflammation

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Serious Adverse Events

  Safety was assessed through serious adverse event collection.

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

Secondary Outcomes (4)

• 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 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 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 24-hour Cough Frequency Per Hour for Period 1

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

Study Arms (2)

ADX-629

EXPERIMENTAL

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

Drug: ADX-629

Placebo

PLACEBO COMPARATOR

Subjects will be randomized to receive matching placebo tablets administered orally twice a day for 14 days.

Drug: Placebo

Interventions

ADX-629 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.

ADX-629

Placebo 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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aldeyra Therapeutics, Inc.: lead

Study Sites (14)

Allergy Associates Medical Group, Inc.

San Diego, California, 92108, United States

Location

Allergy & Asthma Associates of Santa Clara Valley Research Center

San Jose, California, 95117, United States

Location

Cano Research - Hollywood

Hollywood, Florida, 33024, United States

Location

Advanced Pulmonary Research Institute

Loxahatchee Groves, Florida, 33470, United States

Location

Florida Pulmonary Research Institute LLC

Winter Park, Florida, 32789, United States

Location

ClinCept

Columbus, Georgia, 31904, United States

Location

Mayo Clinic Pulmonary Clinic Research Unit

Rochester, Minnesota, 55901, United States

Location

Mount Sinai

New York, New York, 10003, United States

Location

Charlotte Lung & Health/American Health Research

Charlotte, North Carolina, 28277, United States

Location

Bernstein Clinical Research Center, LLC

Cincinnati, Ohio, 45236, United States

Location

Vital Prospects Clinical Research

Tulsa, Oklahoma, 74136, United States

Location

Northwest Research Center

Portland, Oregon, 97202, United States

Location

Clinical Research of Rock Hill

Rock Hill, South Carolina, 29732, United States

Location

Pharmaceutical Research and Consulting Inc.

Dallas, Texas, 72531, United States

Location

MeSH Terms

Conditions

Chronic Cough; Cough; Inflammation

Interventions

ADX-629

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Aldeyra Therapeutics, Inc.

bcavanagh@aldeyra.com

781-257-3063

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 26, 2022
• Study Start: April 7, 2022
• Primary Completion: April 13, 2023
• Study Completion: April 13, 2023
• Last Updated: February 28, 2025
• Results First Posted: February 28, 2025

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)