UMIN-CTR Clinical Trial

Public title

A non-interventional, cross-sectional study to investigate the burden of disease in patients with uncontrolled severe asthma in Japan by internet survey

Acronym

SHIRAHAE study

Scientific Title

A non-interventional, cross-sectional study to investigate the burden of disease in patients with uncontrolled severe asthma in Japan by internet survey

Scientific Title:Acronym

SHIRAHAE study

Region

Japan

Condition

Bronchial asthma

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Severe asthma patients diagnosed as having bronchial asthma who are on continuous treatment with an ICS or ICS/LABA, and particularly, patients with uncontrolled severe asthma, in order to investigate the types (psychological and activity limitations) and degrees of subjective burden in these patients in comparison with patient with severe and non-severe asthma.

Basic objectives2

Others

Basic objectives -Others

Types (psychological and activity limitations) and degrees of subjective burden based on the questions created for this study

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Types (psychological and activity limitations) and degrees of subjective burden based on the questions created for this study

Key secondary outcomes

1)Demographic characteristics (e.g., age, BMI and smoking history)
2)Current asthma control level assessed using ACT
3)Current QOL assessed using AHQ-33, JAPAN
4)Degree of satisfaction with current treatment and the frequency of symptoms based on the questions created for this study
5)Expectations regarding treatment with antiasthmatic drugs based on the questions created for this study
6)Reproducibility of the questions on subjective burden based on the questions created for this study, and the correlation between the ACT and AHQ-33, JAPAN

Study type

Others,meta-analysis etc

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who meet all of the following inclusion criteria will be enrolled in the study:
1) Patients who provide consent based on the informed consent document made available on the website
2) Men or women aged 20 years or older on the date of consent
3) Patients who have been diagnosed as having bronchial asthma* by a physician at least one year prior to the date of consent
4) Patients who have been prescribed an ICS or ICS/LABA continuously on the date of consent
5) Patients who have taken at least 80% of their prescribed medication of ICS or ICS/LABA during the month immediately prior to the date of consent

* This study includes patients who reported their disease name as cough variant asthma because they may have not fully understood their diagnosis

Key exclusion criteria

Patients who meet the following criterion will be excluded from enrollment in the study:
Patients who are unlikely to be able to follow the instructions for the study based on their completion status of questionnaires

Target sample size

4000

Name of lead principal investigator

1st name
Middle name
Last name	Yoko Yoshimura

Organization

AstraZeneca K.K.

Division name

Evidence & Observational Research, Medical

Zip code

Address

Grand Front Osaka Tower B 3-1 Ofuka-cho, Kita-ku, Osaka, Japan

TEL

+81-6-7711-3560

Email

Yoko.Yoshimura@astrazeneca.com

Name of contact person

1st name
Middle name
Last name	TOMOYOSHI KANEKO

Organization

Mebix, Inc.

Division name

Research promotion division

Zip code

Address

Akasaka Intercity 11F, 1-11-44 Akasaka, Minato-ku, Tokyo, 107-0052, Japan

TEL

+81-3-4362-4504

Homepage URL

Email

kaneko@mebix.co.jp

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

YES

Study ID_1

D3250R00028

Org. issuing International ID_1

AstraZeneca K.K.

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

07

Month

06

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

2017

Year

06

Month

07

Day

Date of IRB

Anticipated trial start date

2017

Year

11

Month

30

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Severe asthma patients diagnosed as having bronchial asthma who are on continuous treatment with an ICS or ICS/LABA, and particularly, patients with uncontrolled severe asthma, in order to investigate the types (psychological and activity limitations) and degrees of subjective burden in these patients in comparison with patient with severe and non-severe asthma.

Registered date

2017

Year

07

Month

05

Day

Last modified on

2018

Year

10

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032145