UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Burden of illness and epidemiology of patients with severe asthma in Japan
Title of the study (Brief title)	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	Hisako Matsumoto
Organization	Graduate School of Medicine, Kyoto University
Division name	Department of Respiratory Medicine
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	Hisako Matsumoto
Organization	Graduate School of Medicine, Kyoto University
Division name	Department of Respiratory Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 02 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000023291