Evaluating treatment satisfaction with gefapixant for chronic cough
The Real-world Treatment Satisfaction by Gefapixiant in Patients with Refractory Chronic Cough in Terms of Cough Improvement and Taste Disturbance. (The RESTORE Study)
This study is testing how satisfied adults with stubborn chronic cough are with the treatment gefapixant and whether any taste changes they experience affect their quality of life related to coughing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 63 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nagoya City University Academic / other |
| Locations | 2 sites (Nagoya, Aichi-ken and 1 other locations) |
| Trial ID | NCT06542484 on ClinicalTrials.gov |
What this trial studies
This study aims to assess treatment satisfaction in patients with refractory chronic cough (RCC) who are treated with gefapixant, a P2X3 receptor antagonist. It will explore the relationship between taste disturbances, a common side effect of gefapixant, and improvements in cough-specific quality of life (QoL). The study will involve adult patients who have not responded to standard treatments for chronic cough and will evaluate their experiences in a real-world clinical setting. The hypothesis is that taste disturbance may correlate with enhanced treatment satisfaction and cough-specific QoL.
Who should consider this trial
Good fit: Ideal candidates are adults with refractory chronic cough who have not responded to other treatments and are either never smokers or ex-smokers with limited smoking history.
Not a fit: Patients with lung cancer, significant smoking history, or other respiratory conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve understanding of patient satisfaction and QoL in those suffering from refractory chronic cough.
How similar studies have performed: While gefapixant has shown promise in reducing cough in previous studies, this specific evaluation of treatment satisfaction in a real-world context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult patients with RCC and UCC (8 weeks or more). 2. Cough is refractory to intensive specific treatments for causes of chronic cough. 3. Never smokers and ex-smokers with having smoking history of ≤20 pack-years. Exclusion Criteria: 1. Patients with lung cancer, interstitial lung diseases, bronchiectasis, or respiratory infection such as tuberculosis and acute pneumonia. 2. Current smoker, ex-smokers with having smoking history of \>20 pack-years, or those who quit smoking within six months prior to receiving gefapixant. 3. Those who are pregnant.
Where this trial is running
Nagoya, Aichi-ken and 1 other locations
- Nagoya City University — Nagoya, Aichi-ken, Japan (Not_yet_recruiting)
- Nagoya City University Hospital — Nagoya, Aichi-ken, Japan (Recruiting)
Study contacts
- Principal investigator: Yoshihiro Kanemitsu — Nagoya City University Graduate School of Medical Sciences and Medical School
- Study coordinator: Yoshihiro Kanemitsu, MD, PhD
- Email: kaney32@med.nagoya-cu.ac.jp
- Phone: +81-52-853-8216
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.