UMIN-CTR Clinical Trial

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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