Rhinoconjunctivitis With or Without Allergic Asthma
Conditions
Brief summary
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
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.
Interventions
BIOLOGICALBeltavac® Polymerized with house dust mites
Adminstration of Beltavac® Polymerized with house dust mites according to the routine clinical practice
Sponsors
Probelte Pharma S.L.U.
Alfons Malet i Casajuana
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Years to 11 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Numbers of treatment-related local and systemic reactions | 1 Year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue Scale Score | 1 Year | 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 |
| IgE and IgG4 specific quantification | 1 Year | — |
| Combined symtom and medication score of Rhinoconjunctivitis | 1 Year | The score will be calculated as a sum of the symptoms score (0-3) and medication score (0-3) |
| Combined symtom and medication score of Asthma | 1 Year | The score will be calculated as a sum of the symptoms score (0-3) and medication score (0-3) |
Countries
Spain
Outcome results
None listed