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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-005727-41 | EudraCT Number |
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The objective of this trial is to assess the clinical efficacy of a modified allergen extract of Olea europaea pollen in the treatment of patients affected by allergic rhinitis/rhinoconjunctivitis (with or without episodic asthma) induced by hypersensitivity to olea europaea pollen, evaluating the Score regarding Symptoms and consumption of the medication.
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 |
|---|---|---|---|
| 1 | Experimental | Depigmented and polymerized allergen extract of Olea europaea pollen for subcutaneous injection. |
|
| 2 | Placebo Comparator | Placebo for subcutaneous injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunotherapy with modified extract of Olea europaea pollen | Biological | Subcutaneous immunotherapy with modified extract of Olea europaea. A subcutaneous monthly treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms and medication score | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-response skin prick-test | 2 years | |
| Medication score | 2 years | |
| Rhinoconjunctivitis quality of life questionnaire |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Pedro Guardia, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital El Tomillar | Dos Hermanas | Sevilla | 41700 | Spain | ||
| Hospital Universitario Reina Sofía |
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| Placebo | Biological | Placebo for subcutaneous monthly administration |
|
| 2 years |
| Visual Analog Scales (VAS) | 2 years |
| Serology | 2 years |
| Symptoms score | 2 years |
| Exhaled nitric oxide | 2 years |
| Adverse event | 2 years |
| Córdoba |
| 14004 |
| Spain |
| Hospital Universitario San Cecilio | Granada | 18012 | Spain |
| Complejo Hospitalario de Jaén | Jaén | 23007 | Spain |
| Hospital Universitario Virgen Del Rocio | Seville | 41013 | Spain |
| Clínica Santa Isabel | Seville | 41018 | Spain |
| Hospital Virgen Macarena | Seville | 41071 | Spain |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D007167 | Immunotherapy |
| ID | Term |
|---|---|
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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