UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039245 |
|---|---|
| Receipt number | R000044749 |
| Scientific Title | Prospective study on identification of predictors of effect of omalizumab on seasonal allergic rhinitis in clinical practice |
| Date of disclosure of the study information | 2020/01/24 |
| Last modified on | 2020/01/24 11:44:12 |
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Basic information
Public title
Prospective study on identification of predictors of effect of omalizumab on seasonal allergic rhinitis in clinical practice
Acronym
J-Oasis
Scientific Title
Prospective study on identification of predictors of effect of omalizumab on seasonal allergic rhinitis in clinical practice
Scientific Title:Acronym
J-Oasis
Region
| Japan |
Condition
Condition
Seasonal allergic rhinitis
bronchial asthma
chronic urticaria
Classification by specialty
| Medicine in general | Pneumology | Clinical immunology |
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect predictors of omalizumab for patients with seasonal allergic rhinitis in clinical practice
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Predictors of patients with improved nasal symptom score 12 weeks after omalizumab administration compared to peak symptoms
Key secondary outcomes
1. Percentage of patients with improved nasal symptom score 12 weeks after omalizumab administration compared to peak symptoms.
2. To identify the percentage of patients whose ocular symptom score improved 12 weeks after administration of omalizumab compared to the peak symptom period and to identify predictors of the improvement.
3. To identify the percentage of patients who improved their WPAI-AS score 12 weeks after omalizumab administration compared to the peak period of symptoms and to identify predictors.
4. Therapeutic effects of complications (such as asthma and chronic urticaria)
5. The incidence of Grade 1 or higher adverse events during omalizumab treatment.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who have been treated with second-generation antihistamines, anti-leukotrienes and anti-prostaglandin D2 / thromboxane drugs in addition to nasal spray steroids during the last cedar pollen season, but have poor control
2) Patients who obtained written consent for participation in this study
Key exclusion criteria
1) Patients with serious complications such as heart disease, liver disease, and renal disorder
2) Other patients who are judged inappropriate by the doctor
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Takehiro |
| Middle name | |
| Last name | Izumo |
Organization
Japanese Red Cross Medical Center
Division name
Department of Respiratory Medicine
Zip code
1508935
Address
4-1-22, Hiroo, Shibuya-ku, Tokyo
TEL
0334001311
izumo_takehiro@med.jrc.or.jp
Public contact
Name of contact person
| 1st name | Takehiro |
| Middle name | |
| Last name | Izumo |
Organization
Japanese Red Cross Medical Center
Division name
Department of Respiratory Medicine
Zip code
1508935
Address
4-1-22, Hiroo, Shibuya-ku, Tokyo
TEL
0334001311
Homepage URL
http://www.med.jrc.or.jp/hospital/clinic/tabid/139/Default.aspx
drtake1118@gmail.com
Sponsor or person
Institute
Japanese Red Cross Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japanese Red Cross Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Red Cross Medical Center
Address
4-1-22, Hiroo, Shibuya-ku, Tokyo
Tel
0334001311
drtake1118@gmail.com
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
日本赤十字社医療センター 呼吸器内科（東京都）
日本赤十字社医療センター 耳鼻咽喉科（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Single-center prospective observational study
Management information
Registered date
| 2020 | Year | 01 | Month | 24 | Day |
Last modified on
| 2020 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044749
