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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004498
Receipt No. R000005375
Scientific Title Optimal Stepdown therapy for Controlled pediatric Asthma Responded to SFC (OSCAR) study
Date of disclosure of the study information 2010/11/03
Last modified on 2014/11/03

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Basic information
Public title Optimal Stepdown therapy for Controlled pediatric Asthma Responded to SFC
(OSCAR) study
Acronym Oscar study
Scientific Title Optimal Stepdown therapy for Controlled pediatric Asthma Responded to SFC
(OSCAR) study
Scientific Title:Acronym Oscar study
Region
Japan

Condition
Condition asthma
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To judge the optimal stepdown therapy for children with asthma whose symptoms are controlled with SFC (100/200) by the switch to low dose SFC 100 or FP 200 single treatment by comparing the changes of lung function and airway inflammation level after stepping down.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in predicted morning PEFR value
Key secondary outcomes cahnges in lung function
change in FeNO value
chnages in symptom score

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 SFC (100 mcrg/day)
Interventions/Control_2 FP (200 mcrg/day)
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
5 years-old <=
Age-upper limit
15 years-old >=
Gender Male and Female
Key inclusion criteria Children with asthma whose asthmatic conditions have been stable for more than 12 weeks with SCF.
Children with asthma whose P-ACT shows 25 points or more at the end of run-in period.
Children with asthma whose %PEF shows 80% or more.
Children with asthma in whom measuring lung function and FeNO is available.
Key exclusion criteria Patients in whom steroid (oral/injection) has been adminstered.
Patients who experienced asthma exacerbations during run-in period.
Patients who did not keep diary.
Target sample size 150

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Toshio Katsunuma
Organization Jikei University Daisan Hospital
Division name Department of Pediatrics
Zip code
Address 4-11-1, Izumi-Honcho, Komae City, Tokyo
TEL 03-3480-1151
Email

Public contact
1st name of contact person
1st name
Middle name
Last name
Organization Jikei University Daisan Hospital
Division name Department of Pediatrics
Zip code
Address
TEL
Homepage URL
Email tkatsunuma@jikei.ac.jp

Sponsor
Institute The Jikei University School of Medicine
Institute
Department

Funding Source
Organization The Jikei University Research Fund
Organization
Division
Category of Funding Organization Other
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
2010 Year 11 Month 03 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
2009 Year 10 Month 21 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2014 Year 02 Month 13 Day

Other
Other related information

Management information
Registered date
2010 Year 11 Month 02 Day
Last modified on
2014 Year 11 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005375

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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