UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030776 |
|---|---|
| Receipt number | R000035126 |
| Scientific Title | Nasal discharge eosinophils in childhood asthma as a predictive factor for persistent asthma |
| Date of disclosure of the study information | 2018/01/13 |
| Last modified on | 2018/01/13 17:11:23 |
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Basic information
Public title
Nasal discharge eosinophils in childhood asthma as a predictive factor for persistent asthma
Acronym
Nasal eosinophils as asthma predictive factors
Scientific Title
Nasal discharge eosinophils in childhood asthma as a predictive factor for persistent asthma
Scientific Title:Acronym
Nasal eosinophils as asthma predictive factors
Region
| Japan |
Condition
Condition
Childhood asthma
Classification by specialty
| Clinical immunology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Nasal discharge eosinophils in childhood asthma as a predictive factor for persistent asthma.By each age nasal eosinophil positive rates were examined in asthmatic children. The results pattern were compared with other risk factors.
Basic objectives2
Others
Basic objectives -Others
Other risk factors of development persistent asthma were examined.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
From August to December 2008, among patients with nasal discharge symptoms persistent more than one week nasal eosinophil were examined (180).
Key secondary outcomes
180 patients were divided two groups, one was asthma group (85) and another was non-asthma group (95).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Patients visited Murayama Pediatrics from August to December 2008.
Interventions/Control_2
Nasal eosinophils were examined in patients with nasal discharge symptoms.
Interventions/Control_3
By positive or negative of nasal eosinophil patients were divided into two groups.
Interventions/Control_4
By age patients divided into 4 groups.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Pediatrics with at least 3 recurrent episodes of respiratory symptoms such as coughing, wheezing, and dyspnoea and improvement of bronchodilator inhalation at intervals 1 week. According to the Japanese guidelines for child asthma.
Key exclusion criteria
Patients without asthma symptoms.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihide Murayama |
Organization
Murayama Pediatrics
Division name
Pediatrics
Zip code
Address
3-2-33 Nagayoshi-Nagahara-Higashi Hirano-ku Osaka-shi
TEL
06-6790-8835
norihide99@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norihide Murayama |
Organization
Murayama Pediatrics
Division name
Pediatrics
Zip code
Address
3-2-33 Nagayoshi- Nagahara-Higashi Hirano-ku Osaka-shi
TEL
06-6790-8889
Homepage URL
norihide99@yahoo.co.jp
Sponsor or person
Institute
Murayama Pediatrics
Institute
Department
Personal name
Funding Source
Organization
Murayama Pediatrics
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
村山小児科
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 13 | 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
By each age analysis nasal eosinophil positive
rates increased accompanied with age increased.
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
| 2008 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2008 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2009 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2009 | Year | 01 | Month | 31 | Day |
Other
Other related information
This pattern is similar to other risk factors to develop persistent asthma.
Management information
Registered date
| 2018 | Year | 01 | Month | 11 | Day |
Last modified on
| 2018 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035126
