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
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
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
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
