Chronic CoughPhase 2NCT05392192
A Clinical Trial to Evaluate the Safety and Efficacy in Subjects With Chronic Cough
A Phase 2 study testing ADX-629 in people with Chronic Cough, run by Aldeyra Therapeutics, Inc. at 14 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Cough
- What is being tested?
- ADX-629
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 14 sitesUnited States
- Study dates
- 7 Apr 2022to 13 Apr 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Charlotte Lung & Health/American Health Research
Charlotte, North Carolina, 28277
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, 45236
ClinCept
Columbus, Georgia, 31904
Pharmaceutical Research and Consulting Inc.
Dallas, Texas, 72531
Cano Research - Hollywood
Hollywood, Florida, 33024
Advanced Pulmonary Research Institute
Loxahatchee Groves, Florida, 33470
Mount Sinai
New York, New York, 10003
Northwest Research Center
Portland, Oregon, 97202
Mayo Clinic Pulmonary Clinic Research Unit
Rochester, Minnesota, 55901
Clinical Research of Rock Hill
Rock Hill, South Carolina, 29732
Allergy Associates Medical Group, Inc.
San Diego, California, 92108
Allergy & Asthma Associates of Santa Clara Valley Research Center
San Jose, California, 95117
Vital Prospects Clinical Research
Tulsa, Oklahoma, 74136
Florida Pulmonary Research Institute LLC
Winter Park, Florida, 32789
About this study
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
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
Read the 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
- Being tested
- ADX-629, Placebo
- Keywords
- refractory cough, cough hypersensitivity, ADX-629, unexplained cough, reactive aldehyde species, crossover, inflammation
- Medical subject headings
- Chronic Cough, Cough, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADX-629Drug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| ADX-629 | Experimental | Subjects will be randomized to receive ADX-629 300mg tablets administered orally twice a day for 14 days. Receives: Drug: ADX-629 |
| Placebo | Placebo comparator | Subjects will be randomized to receive matching placebo tablets administered orally twice a day for 14 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Serious Adverse Events
Safety was assessed through serious adverse event collection.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The efficacy assessment period was Day 14. Baseline was Day 1 for Period 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start7 Apr 2022
- Primary completion13 Apr 2023
- Study completion13 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aldeyra Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392192
- Sponsor's protocol ID
- ADX-629-CC-001
- Status last verified
- Jul 2022
- First submitted
- 5 May 2022
- Last updated
- 28 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05392192
- Acronym / sponsor ID
- ADX-629-CC-001
- Conditions
- Chronic Cough
- Keywords
- refractory cough, cough hypersensitivity, ADX-629, unexplained cough, reactive aldehyde species, crossover, inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Aldeyra Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 13 Apr 2023 (actual)
- Study completion
- 13 Apr 2023 (actual)
- First posted
- 26 May 2022 (actual)
- Results
- Posted 28 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADX-629 | Experimental | Drug: ADX-629Subjects will be randomized to receive ADX-629 300mg tablets administered orally twice a day for 14 days. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will be randomized to receive matching placebo tablets administered orally twice a day for 14 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADX-629Subjects 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. | Drug | ADX-629 |
| PlaceboSubjects 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. | Drug | Placebo |
Primary outcome
Number of Subjects With Serious Adverse Events
Time frame: The safety assessment period was Day 1 - Day 14 for each treatment period.
Safety was assessed through serious adverse event collection.
4 secondary outcomes
Change From Baseline in Awake Cough Frequency Per Hour With Prior Treatment as a Factor
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: The efficacy assessment period was Day 14. Baseline was Day 1 for Period 1.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ADX-629 in people with Chronic Cough, run by Aldeyra Therapeutics, Inc. at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Serious Adverse Events (time frame: The safety assessment period was Day 1 - Day 14 for each treatment period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.