UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004157 |
|---|---|
| Receipt number | 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 | 2020/11/13 14:04:16 |
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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
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
fujisawa@mie-m.hosp.go.jp
Sponsor or person
Institute
Kinki Hokuriku Airway Disease Conference
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004992
