Actively Recruiting
The Real-world Treatment Satisfaction by Gefapixiant in Patients with Refractory Chronic Cough in Terms of Cough Improvement and Taste Disturbance (The RESTORE Study)
Led by Nagoya City University · Updated on 2025-01-29
63
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
Sponsors
N
Nagoya City University
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating gefapixant, a P2X3 receptor antagonist, for patients with refractory chronic cough (RCC), a condition where cough persists despite usual treatments. This study aims to understand how taste disturbances caused by gefapixant relate to improvements in cough-specific quality of life and overall treatment satisfaction. Additionally, the study will explore potential biomarkers to help predict which patients respond well to gefapixant. Participants will receive 45 mg of gefapixant twice daily for 12 weeks. The study focuses on real-world clinical use and investigates the relationship between taste changes and cough improvement. Researchers will monitor treatment satisfaction, changes in cough-related quality of life, alterations in taste perception, and seek biomarkers during the treatment period. During the trial, participants will be assessed at 12 weeks for treatment satisfaction, changes in cough-specific quality of life, taste changes, and potential biomarkers. The study will include questionnaires and clinical evaluations to track these outcomes. The total participation covers the 12-week treatment period, with data collection focused on understanding how taste disturbances impact patient experience and cough improvement.
CONDITIONS
Brief Title
The Real-world Treatment Satisfaction by Gefapixiant in RCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients with refractory chronic cough (RCC) or unexplained chronic cough (UCC) lasting 8 weeks or more
- Cough that does not improve despite intensive specific treatments
- Never smokers or ex-smokers with a smoking history of 20 pack-years or less
You will not qualify if you...
- Patients with lung cancer, interstitial lung diseases, bronchiectasis, or respiratory infections such as tuberculosis or acute pneumonia
- Current smokers, ex-smokers with a smoking history over 20 pack-years, or those who quit smoking within six months prior to treatment
- Pregnant individuals
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants take 45 mg of gefapixant twice a day as treatment for refractory chronic cough.
Trial Site Locations
Total: 2 locations
1
Nagoya City University
Nagoya, Aichi-ken, Japan, 467-8601
Not Yet Recruiting
2
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan, 4678601
Actively Recruiting
Research Team
Y
Yoshihiro Kanemitsu, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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