The Real-world Treatment Satisfaction by Gefapixiant in RCC

NCT06542484 | Recruiting DMC

• 1 other identifier: NagoyaCU-RCC
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Cough

Keywords

Chronic Cough; gefapixiant

Outcome Measures

Primary Outcomes (1)

• Treatment satisfaction

  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)

  12 weeks

Secondary Outcomes (3)

• The change in cough-specific quality of life and clinical factors

  12 weeks

• The changes in the core five tastes

  12 weeks

• Seeking biomarkers

  12 weeks

Study Arms (1)

Gefapixiant arm

EXPERIMENTAL

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

Drug: Gefapixant Citrate

Interventions

Gefapixant Citrate DRUG

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

Also known as: LYFNUA Tablets

Gefapixiant arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nagoya City University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

Nagoya City University

Nagoya, Aichi-ken, 467-8601, Japan

NOT YET RECRUITING

Nagoya City University Hospital

Nagoya, Aichi-ken, 4678601, Japan

RECRUITING

MeSH Terms

Conditions

Chronic Cough

Condition Hierarchy (Ancestors)

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yoshihiro Kanemitsu

  Nagoya City University Graduate School of Medical Sciences and Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoshihiro Kanemitsu, MD, PhD

CONTACT

+81-52-853-8216; kaney32@med.nagoya-cu.ac.jp

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 7, 2024
• Study Start: December 4, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 29, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2)