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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020163
Receipt No. R000023291
Scientific Title Burden of illness and epidemiology of patients with severe asthma in Japan
Date of disclosure of the study information 2015/12/11
Last modified on 2018/12/12

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Basic information
Public title Burden of illness and epidemiology of patients with severe asthma in Japan
Acronym Japanese EPI/BOI Study in Severe Asthma
Scientific Title Burden of illness and epidemiology of patients with severe asthma in Japan
Scientific Title:Acronym Japanese EPI/BOI Study in Severe Asthma
Region
Japan

Condition
Condition Severe asthma
Classification by specialty
Pneumology Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The results of this investigation will be used to describe the characteristics of eosinophilic asthma population as well as to document the burden of eosinophilic asthma on patients and the Japanese health care system.
Basic objectives2 Others
Basic objectives -Others (Primary objective)
1. To determine the prevalence of severe eosinophilic asthma in patients with severe asthma
(Secondary objectives)
1. To describe the prevalence of severe eosinophilic asthma with exacerbation(s) in patients with severe asthma
2. To describe exacerbation frequency over a 12-month Follow-up period in patients with severe asthma and severe eosinophilic asthma
3. To describe asthma-related healthcare expenditures over a 12-month Follow-up period in patients with severe asthma and severe eosinophilic asthma
4. To examine the association between the level of blood eosinophils or other risk factors predicting the occurrence of exacerbations in patients with severe asthma
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Number of severe asthma and severe eosinophilic asthma patients
Key secondary outcomes 1. Number of severe asthma and severe eosinophilic asthma patients with exacerbation(s)
2. Exacerbation over a 12-month Follow-up period
3. Direct medical expenditures associated with Asthma management, management of asthma exacerbation(s) among severe asthma or severe eosinophilic asthma subjects
4. Risk factors for asthma exacerbation among severe asthma patients

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
12 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients aged over 12 years old at index date.
2. Patients with medical records at Respiratory department at Kyoto University Hospital.
3. Patients with at least one record for asthma as defined by ICD-10 codes (J45) at Baseline period
4. Patients prescribed high-dose ICS as defined by JGL (2012) and at least one non-ICS controller for equal or more than 240 days at Baseline period.
Key exclusion criteria 1. No treatment record of asthma as defined by ICD-10 codes (J45) in any of the following periods in order to secure two-years observation during the Baseline and Follow-up period. Given the prescription days at one visit is 120 days, at least one record of asthma will be required within 5 months of pre-baseline, and 5 months of after follow-up period, respectively.
5 months before Baseline period
Follow-up period
5 months after Follow-up period
2. A diagnosis for cystic fibrosis.
3. A diagnosis for any cancer of respiratory system.
4. Any autoimmune diagnoses identified.
5. A diagnosis for a malignant disease under the treatment at the timing of measurement of blood eosinophil counts.
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisako Matsumoto
Organization Graduate School of Medicine, Kyoto University
Division name Department of Respiratory Medicine
Zip code
Address 54Kawaharamachi, Shogoin, Sakyoku, Kyoto City, Kyoto, Japan
TEL 075-751-3830
Email hmatsumo@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hisako Matsumoto
Organization Graduate School of Medicine, Kyoto University
Division name Department of Respiratory Medicine
Zip code
Address 54Kawaharamachi, Shogoin, Sakyoku, Kyoto City, Kyoto, Japan
TEL 075-751-3830
Homepage URL
Email hmatsumo@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization GlaxoSmithKline K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 12 Month 11 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 Completed
Date of protocol fixation
2015 Year 10 Month 02 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective cohort study

Management information
Registered date
2015 Year 12 Month 11 Day
Last modified on
2018 Year 12 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023291

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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