UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000016589
Receipt number	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 10:32:28

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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

Bronchial asthma

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

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 or person

Institute

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

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Value
https://center6.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