The Effect of Acute and Prolonged Administration of Gefapixant on Cough-related Brain Activity in Patients With Chronic Cough

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Australia
The University of Melbourne
RECRUITING
Parkville
Contact Information
Primary
Stuart B Mazzone, PhD
stuart.mazzone@unimelb.edu.au
+61383446457
Backup
Tara G Bautista, PhD
tara.bautista@unimelb.edu.au
+61383446457
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 31
Treatments
Experimental: Gefapixant treatment
Participants will asked to take an oral tablet containing 45mg Gefapixant twice daily (BID).
Related Therapeutic Areas
Sponsors
Collaborators: Monash University, Merck Sharp & Dohme LLC, Melbourne Health
Leads: Stuart Mazzone

This content was sourced from clinicaltrials.gov