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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044672
Receipt No. R000051018
Scientific Title Comparative efficacy and safety of tezepelumab and dupilumab by thresholds of type 2 inflammatory biomarkers in patients with inadequately controlled asthma: a systematic review and network meta-analysis
Date of disclosure of the study information 2021/06/28
Last modified on 2021/08/01

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Basic information
Public title Comparative efficacy and safety of tezepelumab and dupilumab by thresholds of type 2 inflammatory biomarkers in patients with inadequately controlled asthma: a systematic review and network meta-analysis
Acronym Tezepelumab versus Dupilumab in asthma
Scientific Title Comparative efficacy and safety of tezepelumab and dupilumab by thresholds of type 2 inflammatory biomarkers in patients with inadequately controlled asthma: a systematic review and network meta-analysis
Scientific Title:Acronym Tezepelumab versus Dupilumab in asthma
Region
Japan

Condition
Condition Bronchial asthma
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy and safety for inadequately controlled asthma between tezepelumab and existing biologics
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Annualized exacerbation rate
Key secondary outcomes Change in Trough Fev1.0
ACQ score
incidence of any adverse events

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
12 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria patient with inadequately controlled asthma, who had received medium or high-dose inhaled glucocorticoids
Key exclusion criteria Patients under 12 years old
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Koichi
Middle name
Last name Ando
Organization Showa University School of Medicine
Division name Division of Respiratory Medicine and Allergology, Department of Medicine
Zip code 142-8666
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
TEL 03-3784-8532
Email koichi-a@med.showa-u.ac.jp

Public contact
Name of contact person
1st name Koichi
Middle name
Last name Ando
Organization Showa University School of Medicine
Division name Division of Respiratory Medicine and Allergology, Department of Medicine
Zip code 142-8666
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
TEL 03-3784-8532
Homepage URL
Email koichi-a@med.showa-u.ac.jp

Sponsor
Institute Showa University School of Medicine
Institute
Department

Funding Source
Organization Showa University School of Medicine
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 Showa University School of Medicine
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
Tel 03-3784-8532
Email koichi-a@med.showa-u.ac.jp

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
2021 Year 06 Month 28 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 Preinitiation
Date of protocol fixation
2021 Year 06 Month 28 Day
Date of IRB
Anticipated trial start date
2021 Year 06 Month 28 Day
Last follow-up date
2021 Year 08 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This systematic review and network meta-analysis will compare the efficacy and safety of tezepelumab versus dupilumab for inadequately controlled asthma.

Management information
Registered date
2021 Year 06 Month 27 Day
Last modified on
2021 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051018

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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