Phase 2
N=51
A Clinical Trial to Evaluate the Safety and Efficacy in Subjects With Chronic Cough
Chronic Cough
Bottom Line
View on ClinicalTrials.gov: NCT05392192 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Number of Subjects With Serious Adverse Events — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ADX-629 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Aldeyra Therapeutics, Inc.
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Serious Adverse Events |
0; 0 | — |
| SECONDARY Change From Baseline in Awake Cough Frequency Per Hour With Prior Treatment as a Factor |
-7.06; 7.68 | — |
| SECONDARY Change From Baseline in 24-hour Cough Frequency Per Hour With Prior Treatment as a Factor |
-5.57; 6.39 | — |
| SECONDARY Change From Baseline in Awake Cough Frequency Per Hour for Period 1 |
-11.51; 2.45 | — |
| SECONDARY Change From Baseline in 24-hour Cough Frequency Per Hour for Period 1 |
-9.39; 2.02 | — |
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
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.
Data sourced from ClinicalTrials.gov (NCT05392192). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.