UMIN-CTR Clinical Trial

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	2010 Year 07 Month 08 Day
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	2020 Year 11 Month 13 Day

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