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Multicentre Phase II trial, comparing two different administration routes of SLITonePLUS Birch in regard to pharmacodynamic efficacy and tolerability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sublingual administration | Active Comparator | oral immunotherapy with drops applied once daily by single dose containers (200 STU per dose) |
|
| vestibular administration | Active Comparator | oral immunotherapy with drops applied by single dose containers (200 STU per dose) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral immunotherapy | Biological | orally applied specific immunotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic efficacy of two different administration routes of SLITonePLUS Birch | specific antibody determination | after 4, 8, 12, 24, 36 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the two administration routes with regard to safety aspects | adverse events | 36 weeks |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Bieber, MD, PhD | Universitäsklinik Bonn, Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinik Bonn, Dermatology | Bonn | D-53127 | Germany |
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D007167 | Immunotherapy |
| ID | Term |
|---|---|
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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