UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038169 |
|---|---|
| Receipt number | R000043509 |
| 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) |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2019/10/01 11:52:12 |
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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
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
izumo_takehiro@med.jrc.or.jp
Sponsor or person
Institute
Japanese Red Cross Medical Canter
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043509
