UMIN-CTR Clinical Trial

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