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Non-interventional Study to Assess the Safety and Effectiveness Profile of a SCIT Therapy With Beltavac® Polymerized With Cat Dander 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 with cat dander allergic patients (children and adults) in routine medical care. Patients receive a rush schedule administration every month for a year. They attend at least 5 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 cat dander | Biological | Adminstration of Beltavac® Polymerized with cat dander 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 standards | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Combined Symptom and Medication Score of Rhinoconjunctivitis | The score will be calculated as a sum of the symptoms score (0-3) and medication score (0-3) | 12 months |
| Combined Symptom and Medication Score of Asthma |
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Inclusion Criteria:
Exclusion Criteria:
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Patients aged 12 years or older who suffer from allergic rhinoconjunctivitis caused by cat dander
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| Name | Affiliation | Role |
|---|---|---|
| Carolina Mérida | San Cecilio Universitary Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Campus de la Salud University Hospital | Granada | Andalusia | Spain | |||
| Ciudad de Jaen Hospital |
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The score will be calculated as a sum of the symptoms score (0-3) and medication score (0-3)
| 12 months |
| 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" | 12 months |
| IgE and IgG4 specific quantification | IgE and IgG4 quantification in serum at baseline, 6 and 12 months | 6 and 12 months |
| Jaén |
| Andalusia |
| Spain |
| Quirón Campo de Gibraltar Hospital | Palmones | Cádiz | Spain |
| Quirón Malaga Hospital | Málaga | Malaga | Spain |
| Al-lergo Centre Clinic | Barcelona | Spain |
| Bellvitge University Hospital | Barcelona | Spain |
| Alergogranada | Granada | Spain |