UMIN-CTR Clinical Trial

Basic information
Public title	Prospective study on the identification of predictors of efficacy and efficacy/safety of twice-daily inhalers with three components in clinical practice for COPD patients (J-BRAVE)
Acronym	J-BRAVE
Scientific Title	Prospective study on the identification of predictors of efficacy and efficacy/safety of twice-daily inhalers with three components in clinical practice for COPD patients (J-BRAVE)
Scientific Title:Acronym	J-BRAVE
Region	Japan

Condition
Condition	COPD ACO
Classification by specialty	Medicine in general Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the efficacy, safety and predictive factors of Breztri for COPD in clinical practice
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Predictor identification of patients whose CAT score improved by 2 points or more after 12 weeks
Key secondary outcomes	1. Proportion of patients whose CAT score improved by 2 points or more after 12 weeks. 2. Percent improvement in respiratory function after 12 weeks 3. Incidence rate of Grade 1 or higher adverse events during treatment. 4. Incidence rate within 12 weeks 5. When continuing treatment with the drug after 12 weeks, adverse events, COPD control, and exacerbations from the start of treatment with the drug should be as much as possible.

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) Patients with poor control who have already undergone COPD treatment with inhaled steroids, inhaled bronchodilators, inhaled anticholinergic drugs, or a combination of 2 drugs each 2) Patients who have obtained written consent for participation in this study
Key exclusion criteria	1) Patients who have previously been treated with Breztri 2) Patients with serious complications such as heart disease / liver disease / renal disorder 3) Other patients who are judged to be inappropriate as a target by the doctor's judgment
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Takehiro Middle name Last name Izumo
Organization	Japanese Red Cross Medical Canter
Division name	Department of Respiratory Medicine
Zip code	1508935
Address	4-1-22 Hiroo Shibuya-ku Tokyo
TEL	0334001311
Email	izumo_takehiro@med.jrc.or.jp

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

Sponsor
Institute	Japanese Red Cross Medical Canter
Institute
Department

Funding Source
Organization	Japanese Red Cross Medical Canter
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 Canter
Address	4-1-22 Hiroo Shibuya-ku Tokyo
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	2019 Year 10 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	2019 Year 08 Month 01 Day
Date of IRB	2019 Year 09 Month 30 Day
Anticipated trial start date	2019 Year 10 Month 01 Day
Last follow-up date	2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Single institute observational study

Management information
Registered date	2019 Year 10 Month 01 Day
Last modified on	2019 Year 10 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043509