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

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

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

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 65

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Allergo Centre
  • Barcelona, Spain
    • Medical Center Cenvi Medic
  • Madrid, Spain
    • Alergomundo
  • Madrid, Spain
    • Clinica Torrelodones
  • Madrid, Spain
    • Ojeda Clinic
  • Murcia, Spain, 30100
    • University Hospital Virgen de la Arrixaca
  • Murcia, Spain
    • Reina Sofia Universitary Hospital
  • Toledo, Spain
    • Clinica Alergologica Dr Moral
  • Barcelona
    • Vic, Barcelona, Spain
      • Universitary Hospital of Vic
  • Cataluña
    • Barcelona, Cataluña, Spain
      • Medical Center Fedear
  • Madrid
    • Torrejón De Ardoz, Madrid, Spain
      • University Hospital of Torrejon
  • Murcia
    • Cartagena, Murcia, Spain
      • University Hospital of Cartagena
  • Toledo
    • Talavera De La Reina, Toledo, Spain
      • Clínica de Alergia Mar Jiménez Lara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients from the age of 5 on, who suffer from allergic rhinoconjunctivitis caused by Alternaria alternata

Description

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 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 standard	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rhinoconjuntivitis medication intake	Medication intake for allergy symptons control at baseline, 6 and 12 months	1 year
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"	1 year
IgE and IgG4 specific quantification	IgE and IgG4 quantification in serum measured at baseline, 6 and 12 months	1 year

Collaborators and Investigators

• Sponsor: Probelte Pharma S.L.U.
• Investigators: Study Director: Inmaculada Buendía Jiménez, Probelte Pharma

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2018
• Primary Completion (Actual): January 20, 2023
• Study Completion (Actual): January 20, 2023

Study Registration Dates

• First Submitted: July 19, 2018
• First Submitted That Met QC Criteria: July 19, 2018
• First Posted (Actual): July 27, 2018

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-POL-2017-01; PRO-BEL-2017-01 (Other Identifier: AEMPS)

Drug and device information, study documents

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