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| ID | Type | Description | Link |
|---|---|---|---|
| PRO-BEL-2017-01 | Other Identifier | AEMPS |
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Non-interventional Study to Assess the Safety and Effectiveness Profile of a SCIT Therapy With Beltavac® Polymerized With Alternaria alternata in allergic patients
This prospective open multi-centre non-interventional study assess the safety and effectiveness profile of the subcutaneous allergen-specific immunotherapy with Beltavac® Polymerized in Alternaria alternata allergic patients (children and adults) in routine medical care.
Patients receive a rush schedule administration every month for a year. They attend at least 4 study visits to inform about the adverse reactions, the self reported symptoms and the medication intake.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beltavac® Polymerized with Alternaria alternata | Biological | Adminstration of Beltavac® Polymerized with Alternaria alternata according to the routine clinical practice |
| Measure | Description | Time Frame |
|---|---|---|
| Numbers of treatment-related local and systemic reactions | Number of adverse reactions occurred during the treatment period and classified according to the WAO standard | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Rhinoconjuntivitis medication intake | Medication intake for allergy symptons control at baseline, 6 and 12 months | 1 year |
| Visual analogue Scale Score | Psycometric scale that assesses the global allergic disease discomfort. It is a 10 cm line representing severity from 0:"no symptoms" to 10 "highest level of symptoms" |
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Inclusion Criteria:
Exclusion Criteria:
Patients suffering from acute or chronic infections or inflammations Patients suffering from uncontrolled asthma Patients with a known autoimmune disease Patients with active malignant disease Patients requiring beta-blockers Patients having any contraindication for the use of adrenaline
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Patients from the age of 5 on, who suffer from allergic rhinoconjunctivitis caused by Alternaria alternata
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| Name | Affiliation | Role |
|---|---|---|
| Inmaculada Buendía Jiménez | Probelte Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitary Hospital of Vic | Vic | Barcelona | Spain | |||
| Medical Center Fedear |
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| 1 year |
| IgE and IgG4 specific quantification | IgE and IgG4 quantification in serum measured at baseline, 6 and 12 months | 1 year |
| Barcelona |
| Catalonia |
| Spain |
| University Hospital of Torrejon | Torrejón de Ardoz | Madrid | Spain |
| University Hospital of Cartagena | Cartagena | Murcia | Spain |
| Clínica de Alergia Mar Jiménez Lara | Talavera de la Reina | Toledo | Spain |
| Allergo Centre | Barcelona | Spain |
| Medical Center Cenvi Medic | Barcelona | Spain |
| Alergomundo | Madrid | Spain |
| Clinica Torrelodones | Madrid | Spain |
| Ojeda Clinic | Madrid | Spain |
| University Hospital Virgen de la Arrixaca | Murcia | 30100 | Spain |
| Reina Sofia Universitary Hospital | Murcia | Spain |
| Clinica Alergologica Dr Moral | Toledo | Spain |