UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009004 |
|---|---|
| Receipt number | R000010565 |
| Scientific Title | Feasibility and estimate of measuring exhaled nitric oxide levels in young children with asthma |
| Date of disclosure of the study information | 2012/10/01 |
| Last modified on | 2016/10/03 13:20:30 |
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Basic information
Public title
Feasibility and estimate of measuring exhaled nitric oxide levels in young children with asthma
Acronym
FENOLA study
Scientific Title
Feasibility and estimate of measuring exhaled nitric oxide levels in young children with asthma
Scientific Title:Acronym
FENOLA study
Region
| Japan |
Condition
Condition
asthma
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the feasibility of measuring FENO levels and to estimate how they reflect the control levels in asthmatic children 4-6 years of age
Basic objectives2
Others
Basic objectives -Others
To examine FENO measurement success rate by age and gender
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FENO measurement success rate by age and gender
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Niox Mino
Interventions/Control_2
EcoMedics CLD88
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
| 4 | years-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
asthmatic children 4-6 years age
Key exclusion criteria
Children with wheeze except asthma
Severely handicapped children
Children with unstabel respiration
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshio Katsunuma |
Organization
Daisan hospitai,jikei university
Division name
Depertment of Pediatrics
Zip code
Address
4-11-1, Izumihoncho, Komae City, Tokyo
TEL
03-3480-1151
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Daisan hospitai,jikei university
Division name
Depertment of Pediatrics
Zip code
Address
TEL
Homepage URL
tkatsunuma@jikei.ac.jp
Sponsor or person
Institute
Department of Pediatrics, The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Jikei University
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 29 | Day |
Last modified on
| 2016 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010565
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
