Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06542484

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

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

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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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