UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004498 |
|---|---|
| Receipt number | 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 08:35:32 |
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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
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
Public contact
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
tkatsunuma@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005375
