UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000634 |
|---|---|
| Receipt number | 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 09:19:43 |
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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
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
m-ebisawa@sagamihara-hosp.gr.jp
Sponsor or person
Institute
Japanese Society of Pediatric Allergy and Clinical Immunology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000768
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
