UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Nasal discharge eosinophils in childhood asthma as a predictive factor for persistent asthma
Title of the study (Brief title)	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	Norihide Murayama
Organization	Murayama Pediatrics
Division name	Pediatrics
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	Norihide Murayama
Organization	Murayama Pediatrics
Division name	Pediatrics
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 07 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	By each age analysis nasal eosinophil positive rates increased accompanied with age increased.
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