Rhinoconjunctivitis With or Without Allergic Asthma
Conditions
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.
Interventions
BIOLOGICALBeltavac® Polymerized with cat dander
Adminstration of Beltavac® Polymerized with cat dander according to the routine clinical practice
Sponsors
Probelte Pharma S.L.U.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numbers of treatment-related local and systemic reactions | 12 months | Number of adverse reactions occurred during the treatment period and classified according to the WAO standards |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Combined Symptom and Medication Score of Rhinoconjunctivitis | 12 months | The score will be calculated as a sum of the symptoms score (0-3) and medication score (0-3) |
| Combined Symptom and Medication Score of Asthma | 12 months | The score will be calculated as a sum of the symptoms score (0-3) and medication score (0-3) |
| Visual analogue Scale Score | 12 months | 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 |
| IgE and IgG4 specific quantification | 6 and 12 months | IgE and IgG4 quantification in serum at baseline, 6 and 12 months |
Countries
Spain
Outcome results
None listed