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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030776
Receipt No. 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

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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
Email 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
Email norihide99@yahoo.co.jp

Sponsor
Institute Murayama Pediatrics
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035126

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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