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In this study, participants will receive either intranasal anti-IgE-antibodies (n=5) or intranasal allergen (n=5) or intranasal placebo (n=5). Blood samples will be obtained before nasal administration of study drugs and 3, 5 and 8 weeks thereafter. In the serum samples, specific and total IgE levels will be assessed.
The intranasal challenge study will be performed over 8 weeks outside of the birch pollen season (November to January) as a randomized, double blind and placebo-controlled study. During a screening visit, 15 individuals will be recruited according to eligibility criteria. They will be randomized into 3 groups (i.n. administration of anti-IgE antibodies, Bet v 1 or placebo). Intranasal administration will take place on three consecutive days and serum samples will be taken 3, 5, and 8 weeks (+/- 4 days) after the treatment for analysis of total and specific IgE levels
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intranasal anti-IgE | Experimental | Anti-IgE (Xolair) will be freshly diluted in sterile 0.9% sodium chloride solution (438 μg/ml) and will be administered using a metered pump delivering 15 μl per puff to both nostrils on three consecutive days. |
|
| intranasal allergen | Active Comparator | GMP produced rBet v 1 will be freshly diluted in sterile 0.9% sodium chloride solution (50 μg/ml) and will be administered using a metered pump delivering 15 μl per puff to both nostrils on three consecutive days. |
|
| intranasal saline | Placebo Comparator | Sterile 0.9% sodium chloride solution will be administered using a metered pump delivering 15 μl per puff to both nostrils on three consecutive days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-IgE | Drug | intranasal anti-IgE |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| change of allergen-specific IgE | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| changes in total IgE | 8 weeks |
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Inclusion Criteria:
birch pollen allergy
Exclusion Criteria:
history of anaphylaxis autoimmune diseases treatment with corticosteroids, antihistamines, immunosuppressant drugs, beta-blockers significant medical conditions pregnancy or lactation
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| Name | Affiliation | Role |
|---|---|---|
| Verena Niederberger, MD | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Otorhinolaryngology, Medical University of Vienna | Vienna | A-1090 | Austria |
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C026408 | anti-IgE antibodies |
| D000069444 | Omalizumab |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| intranasal allergen | Other | intranasal allergen |
|
|
| intranasal saline | Other | intranasal placebo |
|
|
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |