The RESTORE study

JRCT ID: jRCTs041240123

Registered date:18/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Refractory chronic cough and unexplained chronic cough
• Date of first enrollment: 18/11/2024
• Target sample size: 63
• Study type: Interventional
• Intervention(s): Gefapixant (45 mg, twice a day) given for 12 weeks

Outcome(s)

• Primary Outcome: To determine factor related to treatment satisfaction by gefapixant in RCC and UCC patients in the multivariate regression analysis.

Secondary Outcome

1. To evaluate the association of changes in the core five tastes such as sweet, sour, bitter, salty, and umami by gefapixant with treatment satisfaction.
2. To evaluate what changes in the core five tastes are associated with the change in cough-specific quality of life (QoL).
3. To evaluate the association of changes in clinical indices by gefapixant with treatment satisfaction.
c). To seek biomarkers that can predict the change of cough-specific quality of life by gefapixant.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients who visit asthma and chronic cough outpatient clinic at Nagoya City University Hospital due to refractory or unexplained chronic cough
2.patients with refractory chronic cough (RCC) and unexplained chronic cough (UCC) (8 weeks or more).
RCC will be defined if cough will be refractory to intensive specific treatments for causes of chronic cough for 8 weeks or longer.
3. 18 years or older
4. Never smokers and ex-smokers with having smoking history of 20 pack-years or less.
5.Those who consented for participation in this research

Exclude 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.
4. Those who were considered to be inappropriate to participate in the study by treating physicians

Related Information

• Primary Sponsor: Kanemitsu Yoshihiro
• Source(s) of Monetary Support: MSD co., ltd.