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

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

Detailed 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.

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

Conditions
-----------------
Rhinoconjunctivitis With or Without Allergic Asthma

Intervention / Treatment
-----------------
* Biological: Beltavac® Polymerized with cat dander


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Beltavac® Polymerized with cat dander|Adminstration of Beltavac® Polymerized with cat dander according to the routine clinical practice|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numbers of treatment-related local and systemic reactions | Number of adverse reactions occurred during the treatment period and classified according to the WAO standards | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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 | 12 months | 
| IgE and IgG4 specific quantification | IgE and IgG4 quantification in serum at baseline, 6 and 12 months | 6 and 12 months |