UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040561 |
|---|---|
| Receipt number | 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 07:46:18 |
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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
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
koichi-a@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046296
