Prospective Study of the Efficacy, Safety and Identification of Predictors of Gefapixant for Refractory Chronic Cough

Prospective Study of the Efficacy, Safety and Identification of Predictors of Gefapixant for Refractory Chronic Cough - J-LUNG

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000047917

Enrollment

Registered

2022-06-01

Start date

2022-06-01

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

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Cough persists for more than 4 months despite clinical evaluation suggesting a causative disease (GERD, asthma, upper respiratory cough syndrome, etc.) that may be associated with cough and despite appropriate diagnostic testing and treatment based on the Japanese Respiratory Society (JRS) guidelines for cough Patients with cough for more than 4 months despite appropriate diagnostic tests and treatment based on the JRS guidelines 2. Patients whose cough clinical evaluation based on the JRS guideline has revealed no relevant causative disease. 3. Patients who give written consent to participate in this study 4. Patients who are 20 years of age or older

Exclusion criteria

Exclusion criteria: 1. Patients with a history of previous administration of gefapixant 2. Patients with serious complications such as cardiac, hepatic, or renal disease 3. Pregnant patients 4. Other patients who are judged to be unsuitable by the physician's judgment.

Design outcomes

Primary

Measure	Time frame
Percentage of patients with an increase of at least 1.3 points in LCQ (Leicester cough questionnaire) score at 12 weeks after gefapixant administration	—

Secondary

Measure	Time frame
1. To compare the improvement of LCQ score and cough VAS (visual analogue scale) by dividing the patients into two groups based on the median values of various predictors of efficacy before administration. 2. To examine the relationship between the amount of change in each index and improvement in LCQ score and cough VAS. 3. To examine the time course of various effect predictors. 4. Change from baseline in LCQ score and cough VAS score. Effects of drug dose reduction. 6. 6. To examine the incidence of Grade 1 or higher adverse events during treatment. 7. 7. If the same drug is continued after 12 weeks, control adverse events and cough control up to 1 year after the start of treatment with the same drug will be taken as far as possible (e.g., at 24 weeks, 52 weeks, etc.).	—

Measure

Time frame

1. To compare the improvement of LCQ score and cough VAS (visual analogue scale) by dividing the patients into two groups based on the median values of various predictors of efficacy before administration. 2. To examine the relationship between the amount of change in each index and improvement in LCQ score and cough VAS. 3. To examine the time course of various effect predictors. 4. Change from baseline in LCQ score and cough VAS score. Effects of drug dose reduction. 6. 6. To examine the incidence of Grade 1 or higher adverse events during treatment. 7. 7. If the same drug is continued after 12 weeks, control adverse events and cough control up to 1 year after the start of treatment with the same drug will be taken as far as possible (e.g., at 24 weeks, 52 weeks, etc.).

—

Countries

Japan

Contacts

Public ContactTakehiro Izumo

Japanese Red Cross Medical Center Department of Respiratory Medicine

izumo_takehiro@med.jrc.or.jp0334001311

Outcome results