UMIN-CTR Clinical Trial

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

Severe asthma

Classification by specialty

Pneumology

Clinical immunology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

GlaxoSmithKline K.K.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

12

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Retrospective cohort study

Registered date

2015

Year

12

Month

11

Day

Last modified on

2018

Year

12

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023291