UMIN-CTR Clinical Trial

Basic information
Public title	Prospective Study of the Efficacy, Safety and Identification of Predictors of Gefapixant for Refractory Chronic Cough
Acronym	J-LUNG
Scientific Title	Prospective Study of the Efficacy, Safety and Identification of Predictors of Gefapixant for Refractory Chronic Cough
Scientific Title:Acronym	J-LUNG
Region	Japan

Condition
Condition	Refractory Chronic Cough
Classification by specialty	Medicine in general Pneumology Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Prospective Study of the Efficacy, Safety and Identification of Predictors of Gefapixant for Refractory Chronic Cough
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Percentage of patients with an increase of at least 1.3 points in LCQ (Leicester cough questionnaire) score at 12 weeks after gefapixant administration
Key secondary outcomes	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.).

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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
Key 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.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Takehiro Middle name Last name Izumo
Organization	Japanese Red Cross Medical Center
Division name	Department of Respiratory Medicine
Zip code	1508935
Address	4-1-22, Hiroo Shibuya-ku, Tokyo, Japan
TEL	0334001311
Email	drtake1118@gmail.com

Public contact
Name of contact person	1st name Takehiro Middle name Last name Izumo
Organization	Japanese Red Cross Medical Center
Division name	Department of Respiratory Medicine
Zip code	1508935
Address	4-1-22, Hiroo Shibuya-ku, Tokyo, Japan
TEL	0334001311
Homepage URL
Email	izumo_takehiro@med.jrc.or.jp

Sponsor
Institute	Japanese Red Cross Medical Center
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Japanese Red Cross Medical Center
Address	4-1-22, Hiroo Shibuya-ku, Tokyo, Japan
Tel	0334001311
Email	izumo_takehiro@med.jrc.or.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2022 Year 05 Month 19 Day
Date of IRB	2022 Year 05 Month 26 Day
Anticipated trial start date	2022 Year 06 Month 01 Day
Last follow-up date	2026 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	objective study

Management information
Registered date	2022 Year 06 Month 01 Day
Last modified on	2022 Year 06 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054626