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| ID | Type | Description | Link |
|---|---|---|---|
| 6018-PG-OSL-142 | Other Identifier | Sponsor protocol number |
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The objective of this trial is to evaluate the clinical effectiveness of the administration of a depigmented and polymerized allergen extract of Olea europaea in the rhinitis or allergic rhinoconjunctivitis
Immunotherapy is a specific treatment for allergic diseases. Unlike conventional pharmacological treatment, immunotherapy is the only treatment that could modify the natural course of allergic disease. This is a prospective double-blind placebo controlled study with two arms of treatment: placebo and active.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Biological Vaccine |
|
| B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunotherapy with modified extract of O. europaea pollen | Biological | Sublingual (2 drops daily during 2 months) |
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| Measure | Description | Time Frame |
|---|---|---|
| Symptom score | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-response skin prick-test | 1 year | |
| Medication score | 1 year | |
| Rhinoconjunctivitis quality of life questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan Luis Anguita, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitatio Ciudad de Jaén | Jaén | Jaén | 23007 | Spain |
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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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| 1 year |
| Analogical visual scale | 1 year |
| Serology | 1 year |
| Record of adverse events | 1 year |