跳至主要内容
临床试验/NCT06542484
NCT06542484招募中不适用

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

Nagoya City University2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2024年12月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
63
试验地点
2
主要终点
Treatment satisfaction

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Patients with lung cancer, interstitial lung diseases, bronchiectasis, or respiratory infection such as tuberculosis and acute pneumonia.
  • Current smoker, ex-smokers with having smoking history of >20 pack-years, or those who quit smoking within six months prior to receiving gefapixant.
  • Those who are pregnant.

研究组 & 干预措施

Gefapixiant arm

Experimental

Participants will take 45mg of gefapixiant twice a day for 12 weeks.

干预措施: Gefapixant Citrate (Drug)

结局指标

主要结局

Treatment satisfaction

时间窗: 12 weeks

To evaluate the change in treatment satisfaction with the initiation of gefapixiant and to determine factors related to treatment satisfaction by gefapixant. The investigator will assess overall treatment satisfaction using 5-point Likert scale (1. Very dissatisfied 2. Dissatisfied 3. Neutral 4. Satisfied 5. Very Satisfied) at enrolment and 12 weeks after commencing gefapixant from all participants. The investigator will compare the rate of "Satisfaction" (4. Satisfied 5. Very Satisfied) before and after the initiation of gefapixant using the McNemar analysis. Taste disturbance will also be assessed using the Patient-Reported Outcome version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) classification with slight modification (Grade 0: No change in taste. Grade 1: Altered taste but no change in diet, Grade 2: Altered taste with change in diet; noxious or unpleasant taste; loss of taste; Grade 3 Cease to gefapixant due to altered taste)

次要结局

  • The changes in the core five tastes(12 weeks)
  • Seeking biomarkers(12 weeks)
  • The change in cough-specific quality of life and clinical factors(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yoshihiro Kanemitsu

Lecturer

Nagoya City University

研究点 (2)

Loading locations...

相似试验