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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2008-006369-10 |
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The purpose of this study is to determine whether the oral administration of grass pollen peptides is safe and effective in the treatment of allergic rhinitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| gpASIT 25 | Experimental |
| |
| gpASIT 100 | Experimental |
| |
| gpASIT 400 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gpASIT+TM | Biological | entero-coated capsules containing 25µg of gpASIT+TM |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Evidence of allergic reaction | within the first 14 days (plus or minus 1 day) |
| Measure | Description | Time Frame |
|---|---|---|
| Immunological assessment | 9 months | |
| Allergy symptom and medication scores | grass pollen season 2009 |
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Inclusion Criteria:
A history of seasonal allergic rhinoconjunctivitis (SAR) during the grass pollen season during at least the two previous years A positive skin prick test (wheal diameter >= 3 mm) to grass-pollen mixture Specific IgE against grass pollen (RAST class 2 or IgE > 0.7 kU/l) Asymptomatic to perennial inhalant allergens.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Brugmann | Brussels | 1020 | Belgium | |||
| University Hospital Ghent |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| Placebo |
| Biological |
placebo entero-coated capsules |
|
| gpASIT+TM | Biological | entero-coated capsules containing 100µg of gpASIT+TM |
|
| gpASIT+TM | Biological | entero-coated capsules containing 400µg of gpASIT+TM |
|
| Ghent |
| 9000 |
| Belgium |
| University Hospital Gasthuisberg | Leuven | 3000 | Belgium |
| University Hospital Sart Tilman | Liège | 4000 | Belgium |
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |