Prospective study on identification of predictors of effect of omalizumab on seasonal allergic rhinitis in clinical practice

Prospective study on identification of predictors of effect of omalizumab on seasonal allergic rhinitis in clinical practice - J-Oasis

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000039245

Enrollment

Registered

2020-01-24

Start date

2020-01-23

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seasonal allergic rhinitis bronchial asthma chronic urticaria

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Predictors of patients with improved nasal symptom score 12 weeks after omalizumab administration compared to peak symptoms	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Japan

Contacts

Public ContactTakehiro Izumo

Japanese Red Cross Medical Center Department of Respiratory Medicine

drtake1118@gmail.com0334001311

Outcome results