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Test of pharmacodynamic efficacy and tolerability of a short-time intra-seasonal updosing
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allergy vaccination | Active Comparator | Allergy vaccination by 6 subcutaneous injections to 10,000 SQ-U with 1-3 days intervals, continuation by 2 injections with 10,000 SQ-U with 2-4 weeks intervals |
|
| Subcutaneous injections | Placebo Comparator | Placebo injections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allergy vaccination (Alutard SQ) | Biological | Alutard SQ grasses and rye, 8 subcutaneous injections, updosing to 10.000 SQ-U, duration of treatment 50 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in Immuno globuline E (IgE)-blocking factor | 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability | 9 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ludger Klimek, MD | Center for Rhinology and Allergology, An den Quellen 10, 65183 Wiesbaden, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Rhinology and Allergology | Wiesbaden | D-65183 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23063373 | Result | Pfaar O, Wolf H, Klimek L, Schnitker J, Wustenberg E. Immunologic effect and tolerability of intra-seasonal subcutaneous immunotherapy with an 8-day up-dosing schedule to 10,000 standardized quality-units: a double-blind, randomized, placebo-controlled trial. Clin Ther. 2012 Oct;34(10):2072-81. doi: 10.1016/j.clinthera.2012.09.006. |
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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