Clinical trial NCT06542484: The Real-world Treatment Satisfaction by Gefapixiant in RCC
Official title: The Real-world Treatment Satisfaction by Gefapixiant in Patients with Refractory Chronic Cough in Terms of Cough Improvement and Taste Disturbance. (The RESTORE Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Cough
Keywords: Chronic Cough
gefapixiant
Lead sponsor: Nagoya City University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2024-08-07
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: Chronic cough has a high global prevalence, but appears to be poorly recognized. Most patients respond to specific treatments against causes of chronic cough. Meanwhile, cough is refractory to such treatments by approximately 20% of patients and they are regarded as "refractory chronic cough (RCC). Gafapixant is a P2X3 receptor antagonist that has demonstrated the reduction of cough in patients with RCC through the inhibition of ATP transmission to afferent nerves. According to the COUGH-1 and COUGH-2, taste disturbance is the most frequent adverse event by gefapixant, with the incidence of 59.3% in COUGH-1 and 68.9% in COUGH-2, respectively. Although 45 mg of gefapixant is well-tolerated even if taste disturbance has occurred, the impact of taste disturbance on cough-specific QoL remains to be unclear in RCC and UCC. Furthermore, both taste disturbance and the improvement of cough by gefapixant would be associated with treatment satisfaction. 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. Furthermore, the investigator would like to evaluate the association of taste disturbance with cough-specific QoL in the real-world clinical practice. In addition, there are no biomarkers available that can predict the efficacy of the improvement of cough by gefapixant. The investigator will also explore biomarkers that can be helpful in predicting well response to gefapixant in RCC and UCC patients.

Eligibility 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.

Primary outcomes:
measure: Treatment satisfaction
timeFrame: 12 weeks
Secondary outcomes:
measure: The change in cough-specific quality of life and clinical factors
timeFrame: 12 weeks
measure: The changes in the core five tastes
timeFrame: 12 weeks
measure: Seeking biomarkers
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nagoya City University
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
state: Aichi
Study officials:
affiliation: Nagoya City University Graduate School of Medical Sciences and Medical School
name: Yoshihiro Kanemitsu
role: PRINCIPAL_INVESTIGATOR
References: