About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Gefapixant Citrate
DrugAn additional treatment of gefapixiant will be performed for 12 weeks.
Treatment groups
Trial outcomes
Primary outcomes
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)
Secondary outcomes
The change in cough-specific quality of life and clinical factors
To evaluate the association between the change in cough-specific quality of life (QoL) using the Leicester Cough Questionnaire (LCQ) and the change in clinical factors with gefapixant. The LCQ questionnaire consists of 19 items with 3 domains. It ranges from 3 to 21, with higher scores indicate better cough-specific QoL.
The changes in the core five tastes
To evaluate the changes in the core five tastes such as sweet, sour, bitter, salty, and umami with the initiation of gefapixiant and to determine what tastes are associated with the change in cough-specific quality of life (QoL). The investigator will evaluate threshold of five basic taste perception with a whole-mouth method using a series of twofold dilutions of the taste solutions including sweet (sucrose), salty (NaCl), sour (tartaric acid), bitter (quinine HCl), and umami (monosodium L-glutamate). These measurements will be conducted before and 12 weeks after the initiation of gefapixant to investigate which taste will be affected by gefapixant. The investigator will prepare for 8 doubling concentrations of these 5 tastes, respectively. Sucrose, citric acid, NaCl, Munosodium glutamate, and quinine HCL will be used to make solutions.
Seeking biomarkers
To seek biomarkers that can predict the change of cough-specific quality of life by gefapixant. Lack of zinc and copper are well-known cause of taste disturbance. Copper/zinc ratio is reported as a good diagnostic marker for taste disorders. Thus, the investigator thinks that they may be associated with the development of taste disturbance by gefapixant. The investigator will measure them because their levels will be helpful when considering the additional zinc therapy for taste disorder in clinical practice. The investigator will also use airway immune cells obtained from sputum samples to measure the expression CD 39 and CD 73 in sputum.
Sponsors and contacts
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Nagoya City University
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator