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The study was designed according to the draft of allergenic product regulation published by Spanish Regulatory Agency. The aim of the study is to evaluate the safety and tolerability of subcutaneous immunotherapy with Olea europaea pollen extract in patients with rhinoconjunctivitis with or without associated mild asthma. In addition, surrogate efficacy parameters will be evaluated: immunoglobulin level changes and skin reactivity
An study conducted througout Spain with 4000 allergic patients (Alergoloógica 2005) showed that 47% of patients with rhinoconjuncitivits and 51% of asthmatic patients were sentitized to olive pollen. This gives us an idea of the importance of this allergen sensitization in Spain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allergovac depot | Experimental | Allergovac depot with Olea europaea pollen extract |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allergovac depot with Olea europaea pollen extract | Biological | Subcutaneous immunotherapy in depot presentation in a rapid dose escalation scheme: 6 weekly increasing dose injections at the initiation phase plus 3 maintenance monthly injections. |
| Measure | Description | Time Frame |
|---|---|---|
| Number and severity of adverse reactions as a measure of Safety and tolerability | 17 weeks treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Immunoglobulin changes from baseline | At baseline and 1 week after last administered dose | |
| Cutaneous reactivity changes from baseline | Skin prick test will be conducted at baseline and 1 week after last administered dose to measure the wheal área changes in mm2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maricruz Gómez Fernández, MD | Roxall Medicina España S.A | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario de Jaén | Jaén | Andalusia | 23007 | Spain | ||
| Hospital Santa Bárbara |
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| At baseline and 1 week after last administered dose |
| Puertollano |
| Ciudad Real |
| Spain |
| Hospital Infanta Cristina | Badajoz | Spain |
| Hospital Costa de la Luz | Huelva | Spain |
| Hospital Nisar Sevilla | Seville | Spain |