Aspirin exacerbated respiratory disease (AERD)
Conditions
Interventions
Period 1: Patients were treated with omalizumab for 3 months, followed by a washout interval of at least 18 weeks. Period 2: Patients were treated with placebo (saline) for 3 months.
Period 1: Patient
Sponsors
Sagamihara National Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients diagnosed with AERD by a systemic aspirin provocation test within the last two years 2) At least one positive result in either a skin test or a serum-specific immunoglobulin E test for common environmental allergens 3) No previous treatment with omalizumab 4) Able to provide written, signed and dated informed consent
Exclusion criteria
Exclusion criteria: 1) Previous treatment with omalizumab 2) Unable to provide written, signed and dated informed consent 3) Patients considered at risk of sinusitis and/or nasal polyp surgery during the study period 4) Patients with comorbidities (renal, hepatic, heart, mental, and malignancy) requiring treatment 5) Pregnancy, breast-feeding, or potential pregnancy 6) Patients considered unsuitable by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in urinary concentration of leukotriene E4 | — |
Countries
Japan
Contacts
Public ContactHiroaki Hayashi
Sagamihara National Hospital Clinical Research Center for Allergy and Rheumatology
Outcome results
None listed