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

Alfons Malet i Casajuana

Status: Completed

Conditions: Rhinoconjunctivitis With or Without Allergic Asthma

Treatments: Biological: Beltavac® Polymerized with house dust mites

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03963947

MAL-BEL-2018-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 97 patients

Sex: All

Ages: 3 to 11 years old

Volunteers: No Healthy Volunteers

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