Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With House Dust Mites
- Conditions
- Rhinoconjunctivitis With or Without Allergic Asthma
- Registration Number
- NCT03963947
- Lead Sponsor
- Alfons Malet i Casajuana
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 97
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Numbers of treatment-related local and systemic reactions 1 Year
- Secondary Outcome Measures
Name Time Method IgE and IgG4 specific quantification 1 Year 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)
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)
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"
Trial Locations
- Locations (1)
Teknon Medical Center
🇪🇸Barcelona, Spain