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

Completed

• Conditions: Rhinoconjunctivitis With or Without Allergic Asthma

• Registration Number: NCT03604718
• Lead Sponsor: Probelte Pharma S.L.U.

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.

Study Timeline

• Study Start: 2018-06-07
• Study First Submitted: 2018-07-19
• Study First Submitted QC: 2018-07-19
• Study First Posted: 2018-07-27
• Primary Completion: 2023-01-20
• Study Completion: 2023-01-20
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-10
• Last Update Posted: 2023-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (13)

Clínica de Alergia Mar Jiménez Lara; 🇪🇸 Talavera De La Reina, Toledo, Spain

University Hospital of Torrejon; 🇪🇸 Torrejón De Ardoz, Madrid, Spain

Universitary Hospital of Vic; 🇪🇸 Vic, Barcelona, Spain

Medical Center Fedear; 🇪🇸 Barcelona, Cataluña, Spain

University Hospital of Cartagena; 🇪🇸 Cartagena, Murcia, Spain

Allergo Centre; 🇪🇸 Barcelona, Spain

Medical Center Cenvi Medic; 🇪🇸 Barcelona, Spain

Reina Sofia Universitary Hospital; 🇪🇸 Murcia, Spain

University Hospital Virgen de la Arrixaca; 🇪🇸 Murcia, Spain

Clinica Alergologica Dr Moral; 🇪🇸 Toledo, Spain

Alergomundo; 🇪🇸 Madrid, Spain

Clinica Torrelodones; 🇪🇸 Madrid, Spain

Ojeda Clinic; 🇪🇸 Madrid, Spain