UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036256 |
|---|---|
| Receipt number | 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 16:39:43 |
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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
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
koichi-a@med.showa-u.ac.jp
Sponsor or person
Institute
Showa university
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
