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The RESTORE study

The real-world treatment satisfaction by gefapixiant in patients with refractory chronic cough in terms of cough improvement and taste disturbance (The RESTORE study)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041240123
Enrollment
63
Registered
2024-11-18
Start date
2024-12-04
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory chronic cough and unexplained chronic cough Refractory chronic cough and unexplained chronic cough

Interventions

Gefapixant (45 mg, twice a day) given for 12 weeks
Chronic cough, Gefapixant, Treatment satisfaction

Sponsors

Kanemitsu Yoshihiro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
To determine factor related to treatment satisfaction by gefapixant in RCC and UCC patients in the multivariate regression analysis.

Secondary

MeasureTime frame
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.

Contacts

Public ContactYoshihiro Kanemitsu

Nagoya City University Hospital

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

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026