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

Launched by STUART MAZZONE · Apr 1, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called Gefapixant, which has shown promise in helping people with chronic cough. The main goal is to understand how this drug affects the brain's response to coughing, both when taken for a short period and over a longer time. Researchers want to find out if the way Gefapixant works in the brain changes depending on how long someone has been taking it. Participants will undergo tests to measure their brain activity and sensitivity to substances that can trigger coughing, as well as fill out questionnaires about their cough before and during the treatment.

To join the study, individuals need to be between 18 and 65 years old, have a chronic cough that hasn’t improved despite treatment, and have not smoked in the past five years. Participants must also be in good health, with no recent severe respiratory infections or neurological conditions. Those selected will be monitored closely and can expect to contribute valuable information that could help improve treatments for chronic cough in the future.

Gender

ALL

Eligibility 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).