UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical research on preparation of bronchial asthma questionnaire in Japan
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Yuji Tohda
Organization	Kinki University Faculty of Medicine
Division name	Department of Respiratory Medicine and Allergology
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	Naoyoshi Sugiyama
Organization	Mebix, Inc.
Division name	Research promotion division
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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