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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016589
Receipt No. R000019243
Scientific Title Clinical research on preparation of bronchial asthma questionnaire in Japan
Date of disclosure of the study information 2015/02/20
Last modified on 2016/04/20

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Basic information
Public title Clinical research on preparation of bronchial asthma questionnaire in Japan
Acronym Clinical research on preparation of bronchial asthma questionnaire in Japan
Scientific Title Clinical research on preparation of bronchial asthma questionnaire in Japan
Scientific Title:Acronym Clinical research on preparation of bronchial asthma questionnaire in Japan
Region
Japan

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

Objectives
Narrative objectives1 To develop new questionnaire to measure the control level of asthma patients in Japan
Basic objectives2 Others
Basic objectives -Others To develop new questionnaire to measure the control level of asthma patients in Japan
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Reliability and Validity of the questionnaire
Key secondary outcomes Study of sensitivity and responsiveness
Study of relationship to existing questionnaires
Study of cut-off values

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Patients with asthma (mild, persistent to severe, persistent)
(2) >= 20 years of age
(3) Patients in Step 2-4 in Asthma Prevention and Management Guideline 2015
(4) Patients who voluntary provide written informed consent form after having been fully informed about and understand the requirements of study participation
(5) Patients who have no problem of communication
Key exclusion criteria (1) Patients with apparent chronic obstructive pulmonary disease (COPD)
(2) Patients with respiratory tract infection
(3) Patients with diseases that affect the reply to the questionnaire (4)Patients who were judged unsuitable for enrollment in the study by the investigator
Target sample size 260

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Tohda
Organization Kinki University Faculty of Medicine
Division name Department of Respiratory Medicine and Allergology
Zip code
Address 377-2 Ohnohigashi,Osakasayama, Osaka, 589-8511, Japan
TEL 81-72-366-0221
Email koare-kyoju@med.kindai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoyoshi Sugiyama
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 03-4362-4504
Homepage URL
Email sugiyama@mebix.co.jp

Sponsor
Institute Department of Respiratory Medicine and Allergology, Kinki University Faculty of Medicine
Institute
Department

Funding Source
Organization Kyorin Pharmaceutical Co., LTD.
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 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 02 Month 20 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
2015 Year 01 Month 16 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 20 Day
Last follow-up date
2016 Year 01 Month 29 Day
Date of closure to data entry
2016 Year 02 Month 15 Day
Date trial data considered complete
2016 Year 02 Month 15 Day
Date analysis concluded
2016 Year 03 Month 28 Day

Other
Other related information Prospective study of questionnaire.
The Ethics Committee reviewed and approved inclusion of 30 subjects in the first pilot study.
Thirty subjects were enrolled and the first pilot study has been completed.
The Ethics Committee reviewed and approved inclusion of 30 subjects in the second pilot study. Thirty subjects were enrolled and the second pilot study has been completed.
Then the Ethics Committee reviewed and approved inclusion of 200 subjects in a validation study.
Two-hundred-twenty-six subjects were enrolled, and the validation study has been completed.

Management information
Registered date
2015 Year 02 Month 20 Day
Last modified on
2016 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019243

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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