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

Completed

• Conditions: Rhinoconjunctivitis With or Without Allergic Asthma

• Registration Number: NCT04207697
• 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 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.

Study Timeline

• Study Start: 2019-12-01
• Study First Submitted: 2019-12-19
• Study First Submitted QC: 2019-12-19
• Study First Posted: 2019-12-23
• Primary Completion: 2023-02-09
• Study Completion: 2023-02-09
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-10
• Last Update Posted: 2023-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

Campus de la Salud University Hospital; 🇪🇸 Granada, Andalucía, Spain

Quirón Malaga Hospital; 🇪🇸 Málaga, Malaga, Spain

Ciudad de Jaen Hospital; 🇪🇸 Jaén, Andalucía, Spain

Bellvitge University Hospital; 🇪🇸 Barcelona, Spain

Al-lergo Centre Clinic; 🇪🇸 Barcelona, Spain

Alergogranada; 🇪🇸 Granada, Spain

Quirón Campo de Gibraltar Hospital; 🇪🇸 Palmones, Cádiz, Spain