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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-002808-18 | EudraCT Number |
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Dose-response trial with a cocktail of recombinant major allergens of Timothy Grass Pollen (Phleum pratense)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo: Al(OH)3-Placebos with histamine-dihydrochloride analogue Allergen-Adsorbate rPhleum strengthes 1 to 4. |
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| 20 μg rPhleum Immunotherapy | Experimental | Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 1 (20 μg) |
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| 40 μg rPhleum Immunotherapy | Experimental | Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 2 (40 μg) |
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| 80 μg rPhleum Immunotherapy | Experimental | Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 3 (80 μg) |
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| 120 μg rPhleum Immunotherapy | Experimental | Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 4 (120 μg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | Placebo: Al(OH)3-Placebos with histamine-dihydrochloride analogue Allergen-Adsorbate rPhleum strengthes 1 to 4. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Systemic reaction (according to Tryba) | Number of patients with at least one systemic reaction (according to Tryba Grade 1-4) with possible, probable or definite relationship to the study medication determined at the end of the uptitration phase. | uptitration phase |
| Measure | Description | Time Frame |
|---|---|---|
| Late Phase Reactions | Changes of the Late Phase Reactions in specific intracutaneous test with natural allergen before and at the end of the double-blind placebo controlled phase before grass pollen season. | before and at the end of the double-blind phase |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karl Hörmann, MD | Universitätsklinikum Mannheim GMBH | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prof. Dr. med. Ludger Klimek | Wiesbaden | Baden-W. | 68167 | Germany |
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| Label | URL |
|---|---|
| Leader in specific allergy research and therapy | View source |
| Click here for information about this trial in the European Clinical Trials Register | View source |
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| rPhleum | Biological | Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 1 (20 μg) |
|
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| rPhleum | Biological | Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 2 (40 μg) |
|
|
| rPhleum | Biological | Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 3 (80 μg) |
|
|
| rPhleum | Biological | Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 4 (120 μg) |
|
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