Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With Alternaria Alternata

Probelte Pharma

Status: Completed

Conditions: Rhinoconjunctivitis With or Without Allergic Asthma

Treatments: Biological: Beltavac® Polymerized with Alternaria alternata

Study type: Observational

Funder types: Industry

Identifiers

NCT03604718

PRO-BEL-2017-01 (Other Identifier)

PRO-POL-2017-01

Details and patient eligibility

About

Non-interventional Study to Assess the Safety and Effectiveness Profile of a SCIT Therapy With Beltavac® Polymerized With Alternaria alternata 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 in Alternaria alternata allergic patients (children and adults) in routine medical care.

Patients receive a rush schedule administration every month for a year. They attend at least 4 study visits to inform about the adverse reactions, the self reported symptoms and the medication intake.

Enrollment: 65 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients of the age of 5 years and older suffering from a clinically relevant Alternaria alternata induced allergic rhinitis
• Positive skin testing or IgE determination to the relevant allergen

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