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 Alternaria alternata 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 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.
Interventions
BIOLOGICALBeltavac® Polymerized with Alternaria alternata
Adminstration of Beltavac® Polymerized with Alternaria alternata 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
5 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numbers of treatment-related local and systemic reactions | 1 year | Number of adverse reactions occurred during the treatment period and classified according to the WAO standard |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rhinoconjuntivitis medication intake | 1 year | Medication intake for allergy symptons control at baseline, 6 and 12 months |
| Visual analogue Scale Score | 1 year | 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 | 1 year | IgE and IgG4 quantification in serum measured at baseline, 6 and 12 months |
Countries
Spain
Outcome results
None listed