Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With Cat Dander

Probelte Pharma

Status: Completed

Conditions: Rhinoconjunctivitis With or Without Allergic Asthma

Treatments: Biological: Beltavac® Polymerized with cat dander

Study type: Observational

Funder types: Industry

Identifiers

NCT04207697

PRO-BEL-2019-01

Details and patient eligibility

About

Non-interventional Study to Assess the Safety and Effectiveness Profile of a SCIT Therapy With Beltavac® Polymerized With Cat Dander in allergic patients

Full description

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.

Enrollment: 34 patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients of the age of 12 years and older suffering from a clinically relevant cat dander induced allergic rhinitis or rhinoconjunctivitis associated with or not with asthma
• Positive skin testing
• Positive Serum-Specific IgE determination
• Informed consent

Exclusion criteria

• Patients suffering from acute or chronic infections or inflammations
• Patients suffering from uncontrolled 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