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This is an observational prospective study to assess the tolerability and safety of treatment of SCIT Allergovac Poliplus polymerized in depot presentation. The study drug will be administered either by a 1 day Schedule or by a rapid Schedule (3 increasing weekly doses at initiation period till maintenance dose is reached) The study population is both: adult and child, polysensitized to at least 2 allergen sources with rhinitis or allergic rhinoconjunctivitis. Patients may also present a concomitant mild or moderate asthma.
The assignment of a patient to a particular therapeutic strategy will not be decided in advanced by a trial protocol but will be determined by routine clinical practice. The decision of the investigator to prescribe a particular treatment will be clearly dissociated from the decision to include the patient in the study. The patients will not suffer any intervention, whether diagnostic or monitoring, other than the usual in clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 day initiation schedule | The initiation Schedule consists in administering 0.2 mL and 0.3 mL with 30 minutes of interval in the same day. Thus, the patient will reach the maintenance dose of 0.5 mL in one day. |
| |
| Rapid initiation schedule | The patient will receive 3 increasing doses (0.1 mL + 0.3mL + 0.5 mL) weekly doses till the maintenance dose (0.5 mL) is reached. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allergovac Poliplus | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and severity of adverse drug reactions | From patient ICF signature till 1 week after last administered dose |
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Inclusion Criteria:
Exclusion Criteria:
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Polisensitized patients with allergic rinitis and rhinoconjunctivitis with or without associated mild or moderate asthma
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| C.H.U A Coruña | A Coruña | Spain | ||||
| Hopsital de Vinalopó |
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| Elche |
| Spain |
| Clínica Dr. Arias Irigoyen | Huelva | Spain |
| Clínica Dra. Victoria Moreno | Huelva | Spain |
| Hospital de Lugo | Lugo | Spain |
| Clínica de Asma y Alergia Dres. Ojeda | Madrid | Spain |
| Hospital Principe de Asturias | Madrid | Spain |
| Hospital Puerta de Hierro | Madrid | Spain |
| Hospital de Onteniente | Ontinyent | Spain |
| Hospital de Tórax | Santa Cruz de Tenerife | Spain |
| Hospital Ntra. Sra de la Candelaria | Santa Cruz de Tenerife | Spain |
| Hospital Joan XXIII | Tarragona | Spain |
| Hospital de Terrassa | Terrassa | Spain |
| Hospital de Manises | Valencia | Spain |
| Hospital de Xátiva | Xátiva | Spain |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D001249 | Asthma |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
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