Investigating the effects of Gefapixant on brain activity related to chronic cough
The Effect of Acute and Prolonged Administration of Gefapixant on Cough-related Brain Activity in Patients With Chronic Cough
This study is testing how the drug Gefapixant affects brain activity related to coughing in people with chronic cough to see if it helps manage their symptoms.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 31 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Melbourne Academic / other |
| Locations | 1 site (Parkville, Victoria) |
| Trial ID | NCT05813223 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to explore how the drug Gefapixant affects cough-related brain activity in patients suffering from chronic cough. It will assess both acute and prolonged administration of the drug, focusing on its mechanism of action within the brain circuits that regulate coughing. Participants will undergo non-invasive brain imaging while exposed to cough-inducing stimuli, and their cough sensitivity will be measured through questionnaires and inhalation challenges. The study seeks to provide insights into the effectiveness of Gefapixant in managing chronic cough symptoms.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 with refractory or unexplained chronic cough lasting over a year.
Not a fit: Patients who are current smokers, pregnant women, or those with contraindications to MRI scanning will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from chronic cough, potentially enhancing their quality of life.
How similar studies have performed: Other studies have shown promising results with similar approaches, particularly in the use of Gefapixant for cough suppression.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Parkville, Victoria
- The University of Melbourne — Parkville, Victoria, Australia (Recruiting)
Study contacts
- Principal investigator: Stuart B Mazzone, PhD — +61383446457
- Study coordinator: Stuart B Mazzone, PhD
- Email: stuart.mazzone@unimelb.edu.au
- Phone: +61383446457
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.