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

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

Study Overview

• Status: Completed
• Conditions: Rhinoconjunctivitis With or Without Allergic Asthma
• Intervention / Treatment: Biological: Beltavac® Polymerized with cat dander

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 Type: Observational
• Enrollment (Actual): 34

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Bellvitge University Hospital
  • Barcelona, Spain
    • Al-lergo Centre Clinic
  • Granada, Spain
    • Alergogranada
  • Andalucía
    • Granada, Andalucía, Spain
      • Campus de la Salud University Hospital
    • Jaén, Andalucía, Spain
      • Ciudad de Jaen Hospital
  • Cádiz
    • Palmones, Cádiz, Spain
      • Quirón Campo de Gibraltar Hospital
  • Malaga
    • Málaga, Malaga, Spain
      • Quirón Malaga Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 12 years or older who suffer from allergic rhinoconjunctivitis caused by cat dander

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

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

Collaborators and Investigators

• Sponsor: Probelte Pharma S.L.U.
• Investigators: Principal Investigator: Carolina Mérida, San Cecilio Universitary Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): February 9, 2023
• Study Completion (Actual): February 9, 2023

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: December 19, 2019
• First Posted (Actual): December 23, 2019

Study Record Updates

• Last Update Posted (Actual): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: PRO-BEL-2019-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No