UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047021 |
|---|---|
| Receipt number | R000053646 |
| Scientific Title | The correlation between serum pollen specific IgE and clinical indices before and after omalizumab treatment in patients with severe seasonal allergic rhinitis |
| Date of disclosure of the study information | 2022/02/28 |
| Last modified on | 2025/03/02 16:16:28 |
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Basic information
Public title
The correlation between serum pollen specific IgE and clinical indices before and after omalizumab treatment in patients with severe seasonal allergic rhinitis
Acronym
The correlation between pollen specific IgE and clinical indices before and after omalizumab treatment in seasonal allergic rhinitis
Scientific Title
The correlation between serum pollen specific IgE and clinical indices before and after omalizumab treatment in patients with severe seasonal allergic rhinitis
Scientific Title:Acronym
The correlation between pollen specific IgE and clinical indices before and after omalizumab treatment in seasonal allergic rhinitis
Region
| Japan |
Condition
Condition
seasonal allergic rhinitis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the correlation between serum pollen specific IgE and clinical indices before and after omalizumab treatment in severe allergic rhinitis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To assess the correlation between serum pollen specific IgE and treatment responsiveness of omalizumab
Key secondary outcomes
Base
Study type
Observational
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)patients with severe seasonal allergic rhinitis
(2)patients who take anti-histamine
(3)patients who are equal or older than 12 years old
(4)patients who give informed consent
Key exclusion criteria
(1)patients who take omalizumab
(2)patients who are pregnant or breast feeding
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | tomoko |
| Middle name | |
| Last name | tajiri |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Respiratory Medicine, Allergy and Clinical Immunology
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
+81528538216
tomokot@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | tomoko |
| Middle name | |
| Last name | tajiri |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Respiratory Medicine, Allergy and Clinical Immunology
Zip code
4678601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
+81528587215
Homepage URL
tomokot@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Nagoya City University Graduate School of Medical Sciences
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
Nagoya City University Graduate School of Medical Sciences, Clinical Research Management Center,
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
Tel
+81528538216
tomokot@med.nagoya-cu.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
| 2022 | Year | 02 | Month | 28 | 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
30
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational stody
Management information
Registered date
| 2022 | Year | 02 | Month | 28 | Day |
Last modified on
| 2025 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053646
