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

Recruiting at 14 trial locations

Overseen By BILL CAVANAGH

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Aldeyra Therapeutics, Inc.

Must not be taking: ACE inhibitors

Disqualifiers: Smoking, Cardiovascular disease, Hepatic disease, Malignancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

51 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests ADX-629, an oral medication, on patients with chronic cough that doesn't respond to usual treatments or has no known cause. It aims to see if the medication can safely and effectively reduce their coughing symptoms.

Will I have to stop taking my current medications?

The trial requires you to stop taking antitussive medications (cough suppressants) for the duration of the study. If you are currently taking an ACE inhibitor, you must have stopped it at least 3 months before the screening.

Are You a Good Fit for This Trial?

Inclusion Criteria

You have a history of an ongoing cough that hasn't gone away despite treatment or doesn't have an obvious cause.

Agree to discontinue antitussive medications for the trial duration

Historical Chest radiograph or CT scan that does not demonstrate any abnormality considered to be significantly contributing to chronic cough

Exclusion Criteria

You smoke or have a history of smoking heavily (more than 20 packs of cigarettes).

Recent history of drug or alcohol abuse or a positive urine drug test at screening

You had cancer in the past five years, except for certain types of non-invasive skin and cervical cancers that have been treated and have not come back.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants receive either ADX-629 or placebo orally twice a day for 14 days

2 weeks

Daily administration

Washout

A washout period between treatment periods to clear the drug from the system

2-4 weeks

Treatment Period 2

Participants crossover to receive the alternate treatment (ADX-629 or placebo) for 14 days

2 weeks

Daily administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ADX-629
• Placebo

How Is the Trial Designed?

Group I: ADX-629 Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Aldeyra Therapeutics, Inc.

Lead Sponsor

Trials

34

Recruited

4,700+