The Real-world Treatment Satisfaction by Gefapixiant in RCC

Condition(s) studied

Investigational drug(s) / intervention(s)

Gefapixant Citrate: An additional treatment of gefapixiant will be performed for 12 weeks.

Study 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

Primary outcome measure(s)

• Treatment satisfaction — 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)

Trial sites (2)

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