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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000634
Receipt No. R000000768
Scientific Title Randomized, controlled trial of early intervention with pranlukast for prevention of bronchial asthma in infants with wheezy bronchitis and atopy
Date of disclosure of the study information 2007/04/01
Last modified on 2013/09/10

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Basic information
Public title Randomized, controlled trial of early intervention with pranlukast for prevention of bronchial asthma in infants with wheezy bronchitis and atopy
Acronym PREDA study
Scientific Title Randomized, controlled trial of early intervention with pranlukast for prevention of bronchial asthma in infants with wheezy bronchitis and atopy
Scientific Title:Acronym PREDA study
Region
Japan

Condition
Condition Infants between 1 and 3 years old, who have severe atopy defined by class 2 and more of Ig E to food and/or environment allergens and history of wheezy bronchitis twice.
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Among infants between 1 and 3 years old with wheezy bronchitis and atopy, this study aimes to evaluate the efficacy of Pranlukast in preventing development of asthma attack or persistent condition by conducting a double blind precebo controlled randomized clinical trial.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes occurence of intermittent asthma attack or shift to persistent ashtma
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 pranlukast
Interventions/Control_2 placebo
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
1 years-old <=
Age-upper limit
3 years-old >
Gender Male and Female
Key inclusion criteria 1. >= class 2 Ig E RAST to food and/or environmental antigens
2. recurrent wheezes twice in the past
Key exclusion criteria 1. Diagnosed as bronchial asthma and treated with anti-inflammation drugs.
2. Treated with Pranlukast continuously in the past.
3. Treated with anti-histaminics (including anti-allergic drugs) for more than 6 months in the past.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motohiro Ebisawa
Organization National Hospital Organization
Sagamihara National Hospital
Division name Clinical Research Center for Allergy and Rheumatology
Zip code
Address Sakuradai Sagamihara Kanagawa
TEL 042-742-9721
Email

Public contact
Name of contact person
1st name
Middle name
Last name Motohiro Ebisawa
Organization National Hospital Organization
Division name Clinical Research Center for Allergy and Rheumatology
Zip code
Address
TEL
Homepage URL
Email m-ebisawa@sagamihara-hosp.gr.jp

Sponsor
Institute Japanese Society of Pediatric Allergy and Clinical Immunology
Institute
Department

Funding Source
Organization Japan Allergy Foundation
Organization
Division
Category of Funding Organization Non profit foundation
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

Other administrative information
Date of disclosure of the study information
2007 Year 04 Month 01 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 Completed
Date of protocol fixation
2006 Year 12 Month 20 Day
Date of IRB
Anticipated trial start date
2007 Year 04 Month 01 Day
Last follow-up date
2012 Year 11 Month 30 Day
Date of closure to data entry
2012 Year 12 Month 31 Day
Date trial data considered complete
2013 Year 02 Month 28 Day
Date analysis concluded
2013 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2007 Year 03 Month 10 Day
Last modified on
2013 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000768

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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