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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028081
Receipt No. R000032145
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
Date of disclosure of the study information 2017/07/06
Last modified on 2018/10/31

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Basic information
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
Condition Bronchial asthma
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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

Base
Study type Others,meta-analysis etc

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
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

Research contact person
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

Public contact
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

Sponsor
Institute AstraZeneca K.K.
Institute
Department

Funding Source
Organization AstraZeneca 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 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
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 06 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
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
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.

Management information
Registered date
2017 Year 07 Month 05 Day
Last modified on
2018 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032145

Research Plan
Registered date File name
2017/12/27 日本におけるコントロール不良な重症喘息患者を対象とした主観的負荷に関するインターネット調査_Protocol_Ver3.1.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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