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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004852-20 | EudraCT Number |
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This trial is an open, national, multi-centre trial. The trial will be initiated after olive pollen season 2012 and subjects will receive treatment for 6 weeks.
The aim of study is to assess the tolerability of the up-dosing phase of AVANZ Olive. The frequency of patients with adverse reactions will be the primary endpoint.
Frequency of patients with systemic reactions according to EAACI classification, increase in IgG4 and in IgE and reduction in immediate skin reactivity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunotherapy | Experimental | AVANZ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVANZ olea | Biological | Immunotherapy Olea europaea |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of patients with adverse reactions. | From date of inclusion until date of last visit documented, it's expected an average of 6 visits, assessed up to 6 weeks per subject. | Participants will be followed for an expected average of 6 week.s |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of patients with systemic reactions according to EAACI classification. | From date of inclusion until date of last visit documented, it's expected an average of 6 visits, assessed up to 6 weeks per subject. | Participants will be followed for an expected average of 6 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| CARMEN MORENO, MD | HOSPITAL UNIVERSITARIO REINA SOFÍA Córdoba- Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Reina Sofía | Córdoba | Córdoba | 14004 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26213608 | Derived | Moreno C, De San Pedro BS, Millan C, Panizo C, Martin S, Florido F. Exploratory study of tolerability and immunological effect of a short up-dosing immunotherapy phase with a standardised allergen extract derived from pollen of Olea europaea. Clin Transl Allergy. 2015 Jul 24;5:27. doi: 10.1186/s13601-015-0070-y. eCollection 2015. |
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