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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 Parietaria judaica 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.
Parietaria judaica is a weed widespread throughout the Mediterranean área. Prevalence of sensitization to Parietaria judaica's pollen is very high in the Mediterranean areas, reaching 41.4% among allergic patients on the Spanish Mediterranean coast.
The study has been designed as an open trial which will be conducted in 4 Spanish sites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allergovac depot | Experimental | Allergovac depot with Parietaria judaica pollen extract |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allergovac depot with Parietaria judaica pollen extract | Biological | Subcutaneous immunotherapy in depot presentation in a rapid dose escalation scheme: 6 weekly dose increasing 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 | across 17 weeks treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Immunoglobulin changes from baseline | At baseline and 1 week after last administered dose | |
| Skin reactivity changes from baseline | At baseline and 1 week after last administered dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Araitz Landeta | Roxall Medicina España S.A | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Vega Baja | Orihuela | Alicante | 03314 | Spain | ||
| Hospital de Manises |
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| Manises |
| Valencia |
| Spain |
| Hosptal de Sagunto | Sagunto | Valencia | 46520 | Spain |
| Hospital Universitario y Politécnico La Fe | Valencia | 46026 | Spain |
| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C014155 | Parietaria judaica pollen |
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