search
Back to results

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

Primary Purpose

Chronic Cough

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ADX-629
Placebo
Sponsored by
Aldeyra Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Cough focused on measuring refractory cough, cough hypersensitivity, ADX-629, unexplained cough, reactive aldehyde species, crossover, inflammation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Allergy Associates Medical Group, Inc.
  • Allergy & Asthma Associates of Santa Clara Valley Research Center
  • Cano Research - Hollywood
  • Advanced Pulmonary Research Institute
  • Florida Pulmonary Research Institute LLC
  • ClinCept
  • Mayo Clinic Pulmonary Clinic Research Unit
  • Mount Sinai
  • Charlotte Lung & Health/American Health Research
  • Bernstein Clinical Research Center, LLC
  • Vital Prospects Clinical Research
  • Northwest Research Center
  • Clinical Research of Rock Hill
  • Pharmaceutical Research and Consulting Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ADX-629

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of participants with adverse events (AEs)
Collection of AEs

Secondary Outcome Measures

Change from baseline in awake cough frequency after 2-week treatment period
Assessed using an ambulatory cough monitor

Full Information

First Posted
May 5, 2022
Last Updated
June 27, 2023
Sponsor
Aldeyra Therapeutics, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05392192
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 7, 2022 (Actual)
Primary Completion Date
April 13, 2023 (Actual)
Study Completion Date
April 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aldeyra Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Cough
Keywords
refractory cough, cough hypersensitivity, ADX-629, unexplained cough, reactive aldehyde species, crossover, inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ADX-629
Arm Type
Experimental
Arm Description
Subjects will be randomized to receive ADX-629 300mg tablets administered orally twice a day for 14 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will be randomized to receive matching placebo tablets administered orally twice a day for 14 days.
Intervention Type
Drug
Intervention Name(s)
ADX-629
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants with adverse events (AEs)
Description
Collection of AEs
Time Frame
From Baseline to the end of each 14-day treatment period (Day 1 - 14 of each treatment period)
Secondary Outcome Measure Information:
Title
Change from baseline in awake cough frequency after 2-week treatment period
Description
Assessed using an ambulatory cough monitor
Time Frame
Day 1 - 14 of each treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Allergy Associates Medical Group, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Allergy & Asthma Associates of Santa Clara Valley Research Center
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Facility Name
Cano Research - Hollywood
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Advanced Pulmonary Research Institute
City
Loxahatchee Groves
State/Province
Florida
ZIP/Postal Code
33470
Country
United States
Facility Name
Florida Pulmonary Research Institute LLC
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
ClinCept
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Mayo Clinic Pulmonary Clinic Research Unit
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55901
Country
United States
Facility Name
Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Charlotte Lung & Health/American Health Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Bernstein Clinical Research Center, LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Vital Prospects Clinical Research
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Northwest Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97202
Country
United States
Facility Name
Clinical Research of Rock Hill
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
Country
United States
Facility Name
Pharmaceutical Research and Consulting Inc.
City
Dallas
State/Province
Texas
ZIP/Postal Code
72531
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs