None listed
Conditions
Interventions
Drug : i) Treatment Group 1:
• Omalizumab 150 mg SQ at Week 0 and Week 4
• Rescue therapy in hierarchical order: antihistamines ? intranasal steroids/LTRA ? oral corticosteroids
• ± ICS/LABA for asthm
Sponsors
Ajou University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 19 years or older. 2. Diagnosed with perennial and/or seasonal allergic rhinitis, conjunctivitis, and/or asthma (patients in whom seasonal causative allergens are identified through symptoms, allergy skin prick test, or serum specific IgE testing). - Positive serum specific IgE or skin prick test to spring/fall pollen within the last 5 years: - Spring allergens: at least one of birch, alder, hazel, or oak. - Fall allergens: at least one of mugwort, ragweed, or Humulus japonicus. - At least one positive test (serum specific IgE or skin prick test) for house dust mite (HDM). 3. Seasonal causative allergens are identified, and rhinitis/conjunctivitis symptoms recur during the corresponding season for more than 1 year. 4. Received moderate or higher-level rhinitis treatment according to the previous year's medication step. 5. Provided informed consent to participate in the study. 6. Able to understand and complete study questionnaires.
Exclusion criteria
Exclusion criteria: 1. Patients with only perennial allergic rhinitis and no seasonal allergic rhinitis. 2. Patients without any positive serum specific IgE or skin prick test to house dust mite (HDM). 3. Patients whose medication step during the corresponding season in the previous year was below moderate. 4. Patients currently receiving omalizumab for other comorbidities. 5. Patients with a history of hypersensitivity reactions to omalizumab or injections containing excipients (e.g., polysorbate 80). 6. Patients who do not agree to complete study questionnaires.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CSMS (Combined Symptom and Medication Score);Adverse events: somnolence, dry mouth, constipation, urinary retention, injection-site reactions, anaphylaxis, urticaria | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. TNSS (Total Nasal Symptom Score) 2. TESS (Total Eye Symptom Score) 3. Medication Score;4. RCAT (Rhinitis Control Assessment Test);5. Proportion of patients achieving RCAT((Rhinitis Control Assessment Test)) score >21;6. EQ-5D;7. Mean difference in maximum Daily Nasal Symptom Score (DNSS) during the 8-week period;8. Number of days with rhinitis symptoms;9. Frequency of rescue medication use;10. ACT (Asthma Control Test);11. VAS for treatment satisfaction;12. Willingness to choose the same treatment in the next pollen season;13. Plasma IL-10, TGF-ß, and sTRAIL levels (pre- vs. post-treatment) 14. Fraction of regulatory dendritic cells (DCreg) (pre- vs. post-treatment);15. Use and cumulative dose of decongestants and Oral corticosteroids | — |
Countries
Korea, Republic of
Contacts
Public ContactYoung Min Ye
Ajou University Hospital
Outcome results
None listed