RecruitingEarly Phase 1

Effect of Gefapixant on Cough-related Brain Activity in Patients With Chronic Cough

Australia31 participantsStarted 2024-01-01

Plain-language summary

Recently, a new drug called Gefapixant passed phase III clinical trials for cough suppression in patients with chronic cough. The goal of this clinical trial is to investigate the effect of acute and prolonged administration of the drug Gefapixant on cough-related brain activity in patients with chronic cough. The main question it aims to answer is: does the mechanism of action of Gefapixant on the brainstem and brain circuits regulating cough differ between acute and prolonged therapy in people with chronic cough? Participants have their brain activity and their sensitivity to cough-inducing substances measured as well as complete questionnaires about their cough before and while taking daily Gefapixant.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Written informed consent to participate in the study. 18-65 years old; Male or female. * Non-smokers for at least 5 years and have no history of neurological disease or any recent history (over 8 weeks) of acute respiratory infections. * Presence of Refractory Chronic Cough (RCC) or Unexplained Chronic Cough (UCC) for ≥1 year, defined as cough unresponsive to treatment for underlying conditions including reflux disease, asthma and rhinitis. * Presence of cough symptoms as determined by a self-reported cough severity of ≥40mm on 10-point scale on screening. Exclusion Criteria: * Current smokers or recreational drug users. * Women who are pregnant. * People with contraindications to MRI scanning (i.e. metal implants, claustrophobia). * Children and/or young people (ie. \<18 years). * People with an intellectual or mental impairment. * People highly dependent on medical care. * People in existing dependent or unequal relationships with any member of the research team. * People with known allergy to chili (very rare). * Non-English speakers (as English proficiency is required to accurately complete research tasks).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in cough-related brain activity using brain imaging following Gefapixant administration

Timeframe: Gefapixant administration will be for 12 weeks with brain scans to be performed before, 3 days after, and 12 weeks after dosing.

Change in cough-related brain activity using brain imaging following Gefapixant withdrawal

Timeframe: Brain imaging will be performed 1 week after Gefapixant withdrawal (Week 13).

Trial details

NCT IDNCT05813223

SponsorStuart Mazzone

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-31

Contact for this trial

Stuart B Mazzone, PhD

+61383446457 stuart.mazzone@unimelb.edu.au

View on ClinicalTrials.gov More Chronic Cough trials