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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040561
Receipt No. R000046296
Scientific Title Efficacy and safety of omalizumab, an anti-IgE monoclonal antibody, in patients with seasonal allergic rhinitis: a systematic review.
Date of disclosure of the study information 2020/06/01
Last modified on 2020/06/07

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Basic information
Public title Efficacy and safety of omalizumab, an anti-IgE monoclonal antibody, in patients with seasonal allergic rhinitis: a systematic review.
Acronym omalizumab for seasonal allergic rhinitis
Scientific Title Efficacy and safety of omalizumab, an anti-IgE monoclonal antibody, in patients with seasonal allergic rhinitis: a systematic review.
Scientific Title:Acronym omalizumab for seasonal allergic rhinitis
Region
Japan

Condition
Condition seasonal allergic rhinitis
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy and safety of omalizumab for seasonal allergic rhinitis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes daily nasal symptom score
any adverse events
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 A randomized controlled trial evaluating the efficacy and safety of omalizumab in patients with controlled seasonal allergic rhinitis.
Key exclusion criteria Case reports, case-control studies, cohort studies, and single-arm studies.
Target sample size

Research contact person
Name of lead principal investigator
1st name Koichi
Middle name
Last name Ando
Organization Showa University School of Medicine
Division name Department of Medicine, Division of Respiratory Medicine and Allergology,
Zip code 142-8666
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8666, Japan
TEL +81-3-37848532
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 Department of Medicine, Division of Respiratory Medicine and Allergology,
Zip code 140-8666
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8666, Japan
TEL +81-3-37848532
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, Japan
Tel +81-3-37848532
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
2020 Year 06 Month 01 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 2270
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
2020 Year 05 Month 28 Day
Date of IRB
2020 Year 05 Month 28 Day
Anticipated trial start date
2020 Year 05 Month 28 Day
Last follow-up date
2020 Year 06 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Statistical heterogeneity between studies will be assessed using the I2 statistic. This is an indicator of the degree of heterogeneity of the outcome measures, with values above 50% indicating significant heterogeneity. We adopt a random-effects model with or without statistically significant heterogeneity. Effect size assesses the difference in efficacy and safety outcomes between the omalizumab and control groups and is expressed as the mean difference (MD), risk ratio (RR), and 95% confidence interval (CI). Subgroup analysis is performed by antigens causing seasonal allergic rhinitis. Statistical analysis of publication bias is done using Egger's and Peters test. All P values are bilateral, with P < 0.05 being significant. All analyses are performed using RevMan (version 5.3; Cochrane Corporation, Oxford, UK) and STATA (version 14.0; Stata Corp., College Station, TX, USA).

Management information
Registered date
2020 Year 05 Month 28 Day
Last modified on
2020 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046296

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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