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

Rhinoconjunctivitis With or Without Allergic Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03604718
• Other study ID #: PRO-POL-2017-01
• Secondary ID: PRO-BEL-2017-01
• Status: Completed
• Start date: June 7, 2018
• Est. completion date: January 20, 2023

Study information

• Verified date: May 2023
• Source: Probelte Pharma S.L.U.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: January 20, 2023
• Est. primary completion date: January 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rhinoconjunctivitis With or Without Allergic Asthma

Intervention

Biological:
• Beltavac® Polymerized with Alternaria alternata
Adminstration of Beltavac® Polymerized with Alternaria alternata according to the routine clinical practice

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Probelte Pharma S.L.U.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rhinoconjuntivitis medication intake	Medication intake for allergy symptons control at baseline, 6 and 12 months	1 year
Secondary	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
Secondary	IgE and IgG4 specific quantification	IgE and IgG4 quantification in serum measured at baseline, 6 and 12 months	1 year