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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004157
Receipt No. R000004992
Scientific Title Impact of allergic rhinitis on onset and progression of asthma in children
Date of disclosure of the study information 2010/09/05
Last modified on 2016/05/10

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Basic information
Public title Impact of allergic rhinitis on onset and progression of asthma in children
Acronym Impact of Allergic Rhinitis on Atopic March In Children (IRAM study)
Scientific Title Impact of allergic rhinitis on onset and progression of asthma in children
Scientific Title:Acronym Impact of Allergic Rhinitis on Atopic March In Children (IRAM study)
Region
Japan

Condition
Condition bronchial asthma, allergic rhinitis
Classification by specialty
Clinical immunology Pediatrics Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate possible relationship between allergic rhinitis and asthma in infants
Basic objectives2 Others
Basic objectives -Others To investigate early detection of allergic inflammation in the nasal mucosa in infants and to prospectively investigate possible relationship between early nasal allergy and development of asthma and allergic rhinitis in young children
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Onset of asthma
Key secondary outcomes Onset of allergic rhinitis

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
6 months-old <=
Age-upper limit
24 months-old >
Gender Male and Female
Key inclusion criteria patients with diagnosis of atopic dermatitis, food allergy, and/or allergic rhiniits
Key exclusion criteria diagnosis of asthma
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takao Fujisawa
Organization Mie National Hospital
Division name Department of Clinical Research
Zip code
Address 357 Ostao-kubota, Tsu, Mie, Japan
TEL 059-232-2531
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takao Fujisawa
Organization Mie National Hospital
Division name Department of Clinical Research
Zip code
Address 357 Ostao-kubota, Tsu, Mie, Japan
TEL 059-232-2531
Homepage URL
Email fujisawa@mie-m.hosp.go.jp

Sponsor
Institute Kinki Hokuriku Airway Disease Conference
Institute
Department

Funding Source
Organization Kinki Hokuriku Airway Disease Conference
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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 国立病院機構三重病院(三重県)、大同病院(愛知県)、岐阜大学病院(岐阜県)、京都八幡病院(京都府)、大阪府立呼吸器アレルギー医療センター(大阪府)、天理よろず相談所病院(奈良県)、大阪府済生会中津病院(大阪府)、にわクリニック(大阪府)、あぶみクリニック(大阪府)、近畿大学病院(大阪府)、富山大学病院(富山県)、むらかみ小児科(富山県)、おのうえこどもクリニック(富山県)、氷見市民病院(富山県)、黒部市民病院(富山県)、蛍川クリニック(富山県)、高重クリニック(富山県)すざき子ども医院(富山県)大田総合病院(神奈川県)、神戸市立医療センター中央病院(兵庫県)、高知大学病院(高知県)、国立病院機構高知病院(高知県)、県立安芸病院(高知県)県立幡多けんみん病院(高知県)、けら小児科(高知県)、もりはた小児科(高知県)

Other administrative information
Date of disclosure of the study information
2010 Year 09 Month 05 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 No longer recruiting
Date of protocol fixation
2010 Year 04 Month 03 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 01 Day
Last follow-up date
2021 Year 09 Month 30 Day
Date of closure to data entry
2021 Year 11 Month 30 Day
Date trial data considered complete
2021 Year 12 Month 31 Day
Date analysis concluded
2022 Year 04 Month 01 Day

Other
Other related information 1) Factors relating allergic rhinitis
*symptoms of rhinitis
*nasal eosinophilia
*macroscopic findings of nasal mucosa
*inflammatory cells in the nasal mucosa
*ECP, IgE, and specific IgE in nasal exudate

2) Genetic and individual factors
*presense of allergic diseases and treatment for the diseases
*family history of allergic diseases
*serum IgE
*serum specific IgE to house dust mite, japanese cedar pollen, orchard, ragweed, alternaria,aspergillus, cat dander, dog dander, egg white, milk, and wheat
*peripheral blood eosinophils
*specific IgG4 to house dust mite, japanese cedar pollen, and alternaria

3) Environmental factors
*number of siblings, day care, passive smoking, pet
*history of bronchiolitis, hospitalization because of respiratory infection

Management information
Registered date
2010 Year 09 Month 04 Day
Last modified on
2016 Year 05 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004992

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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