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

N/ACompletedNCT04207697

Probelte Pharma S.L.U.34 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Rhinoconjunctivitis With or Without Allergic Asthma

Interventions

Beltavac® Polymerized with cat danderBIOLOGICAL

Adminstration of Beltavac® Polymerized with cat dander according to the routine clinical practice

Eligibility

Sex: ALLMin age: 12 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (7)

Campus de la Salud University Hospital

Granada, Andalusia, Spain

Ciudad de Jaen Hospital

Jaén, Andalusia, Spain

Quirón Campo de Gibraltar Hospital

Palmones, Cádiz, Spain

Quirón Malaga Hospital

Málaga, Malaga, Spain

Outcomes

Primary Outcomes

Numbers of treatment-related local and systemic reactions

Number of adverse reactions occurred during the treatment period and classified according to the WAO standards

Time frame: 12 months

Secondary Outcomes

Combined Symptom and Medication Score of Rhinoconjunctivitis

The score will be calculated as a sum of the symptoms score (0-3) and medication score (0-3)

Time frame: 12 months

Combined Symptom and Medication Score of Asthma

The score will be calculated as a sum of the symptoms score (0-3) and medication score (0-3)

Time frame: 12 months

Visual analogue Scale Score

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"

Time frame: 12 months

IgE and IgG4 specific quantification

IgE and IgG4 quantification in serum at baseline, 6 and 12 months

Time frame: 6 and 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.