Pollen-Food Allergy Syndrome(Birch)
Conditions
Interventions
- According to the allocation results, the study drug (double-blind: BP-GMC ointment or placebo ointment) will be applied to both nasal cavities once a day from Day 1 to Day 14, and then once a week f
Sponsors
Komatsuzaki Keiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who exhibit oral allergy symptoms due to raw apples 2) Patients who are alder or birch specific IgE positive (class 2 or higher) 3) Patients aged 18 to 64 years at the time of obtaining consent 4) Patients who have fully understood the purpose of participating in this study and have given their own voluntary written consent
Exclusion criteria
Exclusion criteria: 1) Patients with a history of anaphylaxis to raw apples 2) Patients whose symptoms are not induced by ingesting 16g or more of raw apples in an oral challenge test 3) Patients who meet any of the following criteria in a skin prick test using BP-GMC ointment 1 The wheal diameter is at least half that of the positive control 2 The wheal diameter is at least 3mm larger than that of the negative control 4) Patients who have experienced frequent nosebleeds 5) Patients who have previously undergone allergen immunotherapy using birch pollen 6) Patients currently undergoing treatment with biological agents such as anti-IgE antibody preparations, anti-IL-5 antibody preparations, anti-IL-4a antibody preparations, and anti-TSLP antibody preparations 7) Patients who have received treatment with steroids or immunosuppressants other than oral, intravenous, and nasal steroids within 4 weeks prior to enrollment 8) Patients who have been diagnosed with or suspected of having an upper or lower respiratory tract or systemic infection within 4 weeks prior to enrollment 9) Patients with acute rhinitis, which is a disease similar to allergic rhinitis, patients suspected of acute or chronic sinusitis, and patients with eosinophilic sinusitis 10) Patients with uncontrolled bronchial asthma 11)Patients undergoing treatment for malignant diseases or under observation 12) Pregnant or potentially pregnant patients 13) Breastfeeding women 14) Patients participating in other clinical trials or specific clinical research at the time of enrollment 15) Otherwise, patients who are deemed inappropriate for participation in this study by the principal investigator(subinvestigator)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who achieved asymptomatic intake of 64 g of raw apple during oral feeding challenge (OFC) in Part A (randomized controlled part) | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A (randomized controlled part) 1 Percentage of patients whose raw apple OFC intake threshold was 4 times higher than before the start of treatment at the end of Part A (%) 2 VAS (mm) for each apple weight at the end of Part A at the end of Part A 3 Change in wheal diameter ratio of SPT by raw apple/birch extract from before the start of treatment at the end of Part A 4 Change in peripheral blood eosinophil count, serum total IgE, serum birch-specific IgE, IgG, IgG1, IgG4, serum Bet v 1-specific IgE, IgG, IgG4, saliva birch-specific IgA/IgG from before the start of treatment at the end of Part A Part B (open-label active drug treatment part) 1 Percentage of patients whose raw apple OFC intake threshold was 4 times higher than that before Part A at the end of Part B (%) 2 VAS (mm) for each apple weight at the end of Part B 3 Change in wheal diameter ratio of SPT by rawapple/birch extract at the end of Part B from before Part A 4 Change in peripheral blood eosinophil count, serum total IgE, serum birch-specific IgE, IgG, IgG1, IgG4, serum Bet v 1-specific IgE, IgG, IgG4, saliva birch-specific IgA, IgG from before Part A at the end of Part B | — |
Contacts
Public ContactKeiko Komatsuzaki
Institute of Science Tokyo Hospital
Outcome results
None listed