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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038167
Receipt No. R000043506
Scientific Title Prospective study on the identification of predictors of efficacy and efficacy/safety of once-daily inhalers with three components in clinical practice for COPD patients (J-TREND)
Date of disclosure of the study information 2019/10/01
Last modified on 2019/10/01

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Basic information
Public title Prospective study on the identification of predictors of efficacy and efficacy/safety of once-daily inhalers with three components in clinical practice for COPD patients (J-TREND)
Acronym J-TREND
Scientific Title Prospective study on the identification of predictors of efficacy and efficacy/safety of once-daily inhalers with three components in clinical practice for COPD patients (J-TREND)
Scientific Title:Acronym J-TREND
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 Trelegy 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 Trelegy
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 07 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 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=R000043506

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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