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

Rhinoconjunctivitis With or Without Allergic Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04207697
• Other study ID #: PRO-BEL-2019-01
• Status: Completed
• Start date: December 1, 2019
• Est. completion date: February 9, 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 Cat Dander 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 9, 2023
• Est. primary completion date: February 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Rhinoconjunctivitis With or Without Allergic Asthma

Intervention

Biological:
• Beltavac® Polymerized with cat dander
Adminstration of Beltavac® Polymerized with cat dander according to the routine clinical practice

Locations

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

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 standards	12 months
Secondary	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
Secondary	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
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"	12 months
Secondary	IgE and IgG4 specific quantification	IgE and IgG4 quantification in serum at baseline, 6 and 12 months	6 and 12 months