The Real-world Treatment Satisfaction by Gefapixiant in Patients with Refractory Chronic Cough in Terms of Cough Improvement and Taste Disturbance. (The RESTORE Study)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Chronic cough has a high global prevalence and it is refractory to such treatments by approximately 20% of patients. Gafapixant is a P2X3 receptor antagonist that has demonstrated the reduction of cough in patients with refractory chronic cough(RCC). Taste disturbance is the most frequent adverse event by gefapixant (approximately 60-70%). Although gefapixant is well-tolerated even if taste disturbance has occurred, the impact of taste disturbance on cough-specific QoL remains to be unclear. Therefore, the investigator would like to evaluate factors related to treatment satisfaction by gefapixant in RCC patients. the investigator hypothesize that taste disturbance will be associated with the improvement of cough specific QoL and treatment satisfaction in RCC patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult patients with RCC and UCC (8 weeks or more).

• Cough is refractory to intensive specific treatments for causes of chronic cough.

• Never smokers and ex-smokers with having smoking history of ≤20 pack-years.

Locations
Other Locations
Japan
Nagoya City University
NOT_YET_RECRUITING
Nagoya
Nagoya City University Hospital
RECRUITING
Nagoya
Contact Information
Primary
Yoshihiro Kanemitsu, MD, PhD
kaney32@med.nagoya-cu.ac.jp
+81-52-853-8216
Time Frame
Start Date: 2024-12-04
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 63
Treatments
Experimental: Gefapixiant arm
Participants will take 45mg of gefapixiant twice a day for 12 weeks.
Related Therapeutic Areas
Sponsors
Collaborators: Merck Sharp & Dohme LLC
Leads: Nagoya City University

This content was sourced from clinicaltrials.gov