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

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

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 Overview

• Status: Completed
• Conditions: Chronic Cough
• Intervention / Treatment: Drug: ADX-629; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92108
      • Allergy Associates Medical Group, Inc.
    • San Jose, California, United States, 95117
      • Allergy & Asthma Associates of Santa Clara Valley Research Center
  • Florida
    • Hollywood, Florida, United States, 33024
      • Cano Research - Hollywood
    • Loxahatchee Groves, Florida, United States, 33470
      • Advanced Pulmonary Research Institute
    • Winter Park, Florida, United States, 32789
      • Florida Pulmonary Research Institute LLC
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Clincept
  • Minnesota
    • Rochester, Minnesota, United States, 55901
      • Mayo Clinic Pulmonary Clinic Research Unit
  • New York
    • New York, New York, United States, 10003
      • Mount Sinai
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • Charlotte Lung & Health/American Health Research
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Bernstein Clinical Research Center, LLC
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Vital Prospects Clinical Research
  • Oregon
    • Portland, Oregon, United States, 97202
      • Northwest Research Center
  • South Carolina
    • Rock Hill, South Carolina, United States, 29732
      • Clinical Research of Rock Hill
  • Texas
    • Dallas, Texas, United States, 72531
      • Pharmaceutical Research and Consulting Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ADX-629; Subjects will be randomized to receive ADX-629 300mg tablets administered orally twice a day for 14 days.	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 Comparator: Placebo; Subjects will be randomized to receive matching placebo tablets administered orally twice a day for 14 days.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Awake Cough Frequency Per Hour With Prior Treatment as a Factor	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.	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	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.	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	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.	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	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.	The efficacy assessment period was Day 14. Baseline was Day 1 for Period 1.

Collaborators and Investigators

• Sponsor: Aldeyra Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2022
• Primary Completion (Actual): April 13, 2023
• Study Completion (Actual): April 13, 2023

Study Registration Dates

• First Submitted: May 5, 2022
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (Actual): May 26, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 24, 2025
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: inflammation; crossover; ADX-629; cough hypersensitivity; refractory cough; unexplained cough; reactive aldehyde species
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Chronic Cough; Cough
• Other Study ID Numbers: ADX-629-CC-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No