UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036256
Receipt No. R000041299
Scientific Title Indirect comparison of dupilumab and benralizumab in patients with inadequately controlled asthma
Date of disclosure of the study information 2019/03/20
Last modified on 2019/03/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Indirect comparison of dupilumab and benralizumab in patients with inadequately controlled asthma
Acronym dupilumab versus benralizumab in inadequately controlled asthma
Scientific Title Indirect comparison of dupilumab and benralizumab in patients with inadequately controlled asthma
Scientific Title:Acronym dupilumab versus benralizumab in inadequately controlled asthma
Region
Japan

Condition
Condition Inadequately controlled asthma
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 comparison of dupilumab versus benralizumab
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes annualized exacerbation rate
Key secondary outcomes change in FEV1.0 from baseline
change in AQLQ fron baseline
any adverse events
any serious adverse events
death caused by 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 Adolescent or adult patients with asthma who met the GINA guidelines diagnostic criteria of 12 years of age or older. Patients with moderate to severe persistent asthma who receive 200uL/day fluticasone or equivalent or more inhaled corticosteroid (ICS) with episode of at least once clinically significant (requiring administered with systemic steroids, or requiring consultation to an emergency outpatient or admission. FEV1.0 before bronchodilator administration is less than 80% (adolescent with less than 90% is acceptable).FEV1.0 reversibility after administration of short acting beta-2 agonist (SABA) is 12% or more, or 200 ml or more.The ACQ-6 score before inclusion is 1.5 or more.
Key exclusion criteria The exclusion criteria was patients under 12 years of age, current smokers, or COPD patients.
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name Koichi
Middle name
Last name Ando
Organization Showa university
Division name Division of Respiratory Medicine and Allergology, Department of Medicine
Zip code 142-8666
Address 1-5-8, Shinagawa-ku, Tokyo, 142-8666, Japan
TEL +81-3-3784-8532
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
Division name Division of Respiratory Medicine and Allergology, Department of Medicine
Zip code 142-8666
Address Hatanodai, 1-5-8, Shinagawa-ku, Tokyo, 142-8666, Japan
TEL +81-3-3784-8532
Homepage URL
Email koichi-a@med.showa-u.ac.jp

Sponsor
Institute Showa university
Institute
Department

Funding Source
Organization Showa university
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
Address Division of Respiratory Medicine and Allergology, Department of Medicine
Tel +81-3-3784-8532
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
2019 Year 03 Month 20 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 2640
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
2019 Year 03 Month 10 Day
Date of IRB
2019 Year 03 Month 15 Day
Anticipated trial start date
2019 Year 03 Month 15 Day
Last follow-up date
2019 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The purpose of this study is to perform a network meta-analysis to indirectly compare dupillumab and benralizumab by blood eosinophil count subgroup.

Management information
Registered date
2019 Year 03 Month 19 Day
Last modified on
2019 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041299

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.