UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016724 |
|---|---|
| Receipt number | R000019411 |
| Scientific Title | Comparative Effectiveness of Inhaled Corticosteroids for Pediatric Asthma: a Bayesian Network Meta-analysis |
| Date of disclosure of the study information | 2015/03/10 |
| Last modified on | 2016/01/15 09:31:32 |
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Basic information
Public title
Comparative Effectiveness of Inhaled Corticosteroids for Pediatric Asthma: a Bayesian Network Meta-analysis
Acronym
Comparative Effectiveness of ICS for Pediatric Asthma
Scientific Title
Comparative Effectiveness of Inhaled Corticosteroids for Pediatric Asthma: a Bayesian Network Meta-analysis
Scientific Title:Acronym
Comparative Effectiveness of ICS for Pediatric Asthma
Region
| Japan |
Condition
Condition
Asthma
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate comparative effectiveness of different inhaled corticosteroids for pediatric asthma, using a Bayesian network meta-a analysis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
We do not define the primary outcome in this study because no single outcome measure actually represents asthma control; instead, multiple asthma outcomes are assessed to see a more complete picture of asthma control by ICS, including pulmonary function, rescues use of medications and urgent health service use.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Randomized controlled trials of children with chronic asthma or children with recurrent wheeze (or preschool wheezer) who use ICS longer than (or equal to) 4 weeks; we accept the definitions for children as used by the investigators in the original studies.
Key exclusion criteria
1. Abstract only (eg, conference paper)
2. Not asthma study (eg, viral bronchiolitis)
3. Study examining dose-response relationship of ICS (because of technical difficulties in incorporating into meta-analysis)
4. Safety assessment study of ICS
5. Short term or intermittent use of ICS
6. Trials with co-intervention
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Takeuchi |
Organization
Graduate School of Medicine and Public Health, Kyoto University,
Division name
Department of Pharmacoepidemiology
Zip code
Address
Yoshidakonoe-cho, Sakyo-ku, Kyoto, Japan
TEL
075-753-4468
msttkch-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masato Takeuchi |
Organization
Graduate School of Medicine and Public Health, Kyoto University,
Division name
Department of Pharmacoepidemiology
Zip code
Address
Yoshidakonoe-cho, Sakyo-ku, Kyoto, Japan
TEL
075-753-4468
Homepage URL
msttkch-tky@umin.ac.jp
Sponsor or person
Institute
Masato Takeuchi, on behalf of Best ICS Study Group
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Pediatric Allergy and Clinical Immunology
Organization
Division
Category of Funding Organization
Other
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
YES
Study ID_1
CRD42015025889
Org. issuing International ID_1
PROSPERO
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
京都大学大学院医学系研究科薬剤疫学教室（京都府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 10 | Day |
Related information
URL releasing protocol
http://bmjopen.bmj.com/content/5/10/e008501.full?sid=a9397f63-7988-4163-9d30-bd6b95e0a1c6
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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 03 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
For developing our protocol, we referred to PRISMA-P 2015 statement.
Management information
Registered date
| 2015 | Year | 03 | Month | 06 | Day |
Last modified on
| 2016 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019411
