UMIN-CTR Clinical Trial

Public title

A non-interventional study to investigate the proportion, characteristics and treatment reality of adult patients with severe and uncontrolled severe asthma using a claims database

Acronym

KEIFU study

Scientific Title

A non-interventional study to investigate the proportion, characteristics and treatment reality of adult patients with severe and uncontrolled severe asthma using a claims database

Scientific Title:Acronym

KEIFU study

Region

Japan

Condition

Asthma

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

It may be very important for clinical decision making and drug prescription to clarify more accurately the prevalence of severe asthma and uncontrolled severe asthma. Therefore, we will focus on investigating the proportion of severe asthma or uncontrolled severe asthma in Japan.

Basic objectives2

Others

Basic objectives -Others

To investigate the proportion of patients with severe and uncontrolled severe asthma in treated asthma patients using a claims database

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Following patient proportion in treated asthma patients;
severe asthma, uncontrolled severe asthma

Key secondary outcomes

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

17

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

-17 years of age and older at the index date
-Patients who had claim within 12 months prior to Index date
-Patients who had a record of asthma diagnosis 12 and more months prior to Index date
-Patients who had 4 or more "claims with for an asthma and record of ICS or ICS/LABA prescription for that visit" within 12 months prior to Index date

Key exclusion criteria

-Patients who didin't have the "claims with for an asthma and record of ICS or ICS/LABA prescription for that visit" within 6 months prior to Index date
-Patients who didin't have the "claims with for an asthma and record of ICS or ICS/LABA prescription for that visit" during the period of more than 6 months and within 12 months prior to Index date

Target sample size

20000

Name of lead principal investigator

1st name
Middle name
Last name	Shigetaka Kouda

Organization

Astrazeneca K.K

Division name

Medical department

Zip code

Address

3-1 Ofukacho, Osaka Kita-ku, Osaka, Granfront Osaka Tower B

TEL

06-4802-3600

Email

Shigetaka.Kouda@astrazeneca.com

Name of contact person

1st name
Middle name
Last name	Yoko Yoshimura

Organization

Astrazeneca K.K

Division name

Medical department Evidence & Observational Research

Zip code

Address

3-1 Ofukacho, Osaka Kita-ku, Osaka, Granfront Osaka Tower B

TEL

06-4802-3600

Homepage URL

Email

yoko.yoshimura@astrazeneca.com

Institute

Astrazeneca K.K

Institute

Department

Personal name

Organization

Astrazeneca 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

2017

Year

06

Month

14

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

The primary analysis set consisted of 10,579 'athma patients under treatment'.
'Athma patients under treatment' included 823 'severe asthma patients'(7.8%). The number (%) of 'uncontrolled severe asthma patients' was 267 patients (2.5%), and that of 'non-severe patients' was 9,756 (92.2%).
Compared to 'non-severe patients', 'uncontrolled severe asthma patients' had a higher frequency in asthma exacerbation and more expensive direct medical expenditure. Also, compared to 'non-severe patients', 'uncontrolled severe asthma patients' had a higher amount of use of systemic steroids.

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

2017

Year

04

Month

21

Day

Date of IRB

Anticipated trial start date

2017

Year

07

Month

31

Day

Last follow-up date

2017

Year

07

Month

31

Day

Date of closure to data entry

2017

Year

07

Month

31

Day

Date trial data considered complete

2017

Year

07

Month

31

Day

Date analysis concluded

2017

Year

07

Month

31

Day

Other related information

Utilize the claims database

Registered date

2017

Year

06

Month

08

Day

Last modified on

2018

Year

10

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031582