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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016724
Receipt No. 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

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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
Email 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
Email msttkch-tky@umin.ac.jp

Sponsor
Institute Masato Takeuchi, on behalf of Best ICS Study Group
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019411

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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