UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003244
Receipt number R000003923
Scientific Title The investigation of asthma prevalence in people over 17 years old by a questionnaire and measurements of fractional exhaled NO
Date of disclosure of the study information 2010/02/23
Last modified on 2012/03/23 14:05:34

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Basic information

Public title

The investigation of asthma prevalence in people over 17 years old by a questionnaire and measurements of fractional exhaled NO

Acronym

The investigation of asthma prevalence by a questionnaire and measurements of fractional exhaled NO

Scientific Title

The investigation of asthma prevalence in people over 17 years old by a questionnaire and measurements of fractional exhaled NO

Scientific Title:Acronym

The investigation of asthma prevalence by a questionnaire and measurements of fractional exhaled NO

Region

Japan


Condition

Condition

Bronchial asthma

Classification by specialty

Pneumology Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the prevalence of bronchial asthma

Basic objectives2

Others

Basic objectives -Others

Usefulness of fractional exhaled NO to investigate the prevalence of asthma

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The ratio of people whose exhaled NO levels are higher than 38 ppb in people over 17 years old.

Key secondary outcomes

The relation between wheeze and fractional exhaled NO in people over 17 years old


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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

People over 17 years old

Key exclusion criteria

None

Target sample size

500


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tamotsu Ishizuka

Organization

Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine

Division name

Gunma University

Zip code


Address

3-39-15 Showa-machi, Maebashi 371-8511, Japan

TEL

027-220-8123

Email



Public contact

Name of contact person

1st name
Middle name
Last name Tamotsu Ishizuka

Organization

Department of Medicine and Molecular Science

Division name

Gunma University Graduate School of Medicine

Zip code


Address

3-39-15 Showa-machi, Maebashi 371-8511, Japan

TEL

027-220-8123

Homepage URL


Email

tamotsui@showa.gunma-u.ac.jp


Sponsor or person

Institute

Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


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

群馬大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2010 Year 02 Month 23 Day


Related information

URL releasing protocol


Publication of results

Published


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

2010 Year 01 Month 27 Day

Date of IRB


Anticipated trial start date

2010 Year 03 Month 01 Day

Last follow-up date

2012 Year 03 Month 01 Day

Date of closure to data entry

2012 Year 03 Month 01 Day

Date trial data considered complete

2012 Year 03 Month 01 Day

Date analysis concluded

2012 Year 03 Month 01 Day


Other

Other related information

We will investigate whether the levels of exhaled nitric oxide are different or not between 2 groups divided by the answer to an ECRHS quentionnaire.


Management information

Registered date

2010 Year 02 Month 23 Day

Last modified on

2012 Year 03 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003923


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name