Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With House Dust Mites

Study Overview
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Brief Summary
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Non-interventional Study to Assess the Safety and Effectiveness Profile of a SCIT Therapy With Beltavac® Polymerised With House Dust Mite in pediatric allergic patients

Detailed Description
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This prospective open multi-center non-interventional study assess the safety and effectiveness profile of the subcutaneous allergen-specific immunotherapy with Beltavac polymerized with house dust mite pediatric allergic patients 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.

Official Title
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Observational Prospective Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With House Dust Mites

Conditions
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Rhinoconjunctivitis With or Without Allergic Asthma

Intervention / Treatment
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* Biological: Beltavac® Polymerized with house dust mites


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients from 3 to 11 years suffering from a clinically relevant Dermatophagoides farinae and Dermatophagoides pteronyssinus induced allergic rhinitis or rhinoconjunctivitis associated with or not with asthma Positive skin testing Positive Serum-Specific IgE determination Parental or legal representative informed consent Clinical sintomatology on the inclusion period Exclusion Criteria: Patients suffering from acute or chronic infections or inflammations Patients suffering from uncontrolled and severe 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 Patients with previous immunotherapy with this allergen or another allergen with cross-reaction Patients with immunotherapy treatment at the time of inclusion

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Beltavac® Polymerized with house dust mites|Adminstration of Beltavac® Polymerized with house dust mites according to the routine clinical practice|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numbers of treatment-related local and systemic reactions |  | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined symtom and medication score of Rhinoconjunctivitis | The score will be calculated as a sum of the symptoms score (0-3) and medication score (0-3) | 1 Year | 
| Combined symtom and medication score of Asthma | The score will be calculated as a sum of the symptoms score (0-3) and medication score (0-3) | 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 | 1 Year | 
| IgE and IgG4 specific quantification |  | 1 Year |