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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039245
Receipt No. 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

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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
Email 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
Email drtake1118@gmail.com

Sponsor
Institute Japanese Red Cross Medical Center
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044749

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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