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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026707
Receipt No. R000030660
Scientific Title Comparative efficacy and safety of anti-IL-5 therapies and placebo in patients with uncontrolled eosinophilic asthma: a meta-analysis of phase 3 trials
Date of disclosure of the study information 2017/03/27
Last modified on 2017/03/26

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Basic information
Public title Comparative efficacy and safety of anti-IL-5 therapies and placebo in patients with uncontrolled eosinophilic asthma: a meta-analysis of phase 3 trials
Acronym efficacy and safety of anti-IL-5 therapies
Scientific Title Comparative efficacy and safety of anti-IL-5 therapies and placebo in patients with uncontrolled eosinophilic asthma: a meta-analysis of phase 3 trials
Scientific Title:Acronym efficacy and safety of anti-IL-5 therapies
Region
Japan

Condition
Condition uncontrolled asthma
Classification by specialty
Pneumology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy and safety of anti-IL-5 therapies at currently recommended dosage and administration compared with placebo in patients with uncontrolled asthma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes rate ratio for asthma exacerbation
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
12 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria uncontrolled asthma
Key exclusion criteria heavy smoker
patients with severe cardiovascular disease
Target sample size 1000

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

Public contact
Name of contact person
1st name
Middle name
Last name koichi ando
Organization Showa University
Division name Division of Respiratory Medicine and Allergology, Department of Medicine
Zip code
Address Hatanodai, 1-5-8, Shinagawa-ku, Tokyo, Japan
TEL +81-3784-8532
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
Address
Tel
Email

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
2017 Year 03 Month 27 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 Completed
Date of protocol fixation
2016 Year 12 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The results of present meta-analysis suggest that anti-IL-5 therapies at currently recommended dosage and administration are effective and generally well-tolerated in patients with uncontrolled eosinophilic asthma. However, the occurrence of injection site reaction warrants specific attention, especially concerning mepolizumab administration.

Management information
Registered date
2017 Year 03 Month 26 Day
Last modified on
2017 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030660

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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