Effect of Gefapixant on Cough-related Brain Activity in Patients With Chronic Cough
ConditionChronic Cough
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorStuart Mazzone
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Gefapixant
Treatment groups
31 Participants
are divided into 1 treatment groupSponsors and collaborators
Stuart Mazzone
Lead sponsor
University of Melbourne
Sponsor institution
Merck Sharp & Dohme LLC
Collaborator
Melbourne Health
Collaborator
Monash University
Collaborator
Source ClinicalTrials.gov