Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With House Dust Mites

Rhinoconjunctivitis With or Without Allergic Asthma Clinical Trial

Official title:

Observational Prospective Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With House Dust Mites

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03963947
• Other study ID #: MAL-BEL-2018-01
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: May 24, 2023

Study information

• Verified date: May 2023
• Source: Centro Medico Teknon
• 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® Polymerised With House Dust Mite in pediatric allergic patients

Description:

This prospective open multi-center non-interventional study assess the safety and effectiveness profile of the subcutaneous allergen-specific immunotherapy with Beltavac polymerized with house dust mite pediatric allergic patients 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: 97
• Est. completion date: May 24, 2023
• Est. primary completion date: May 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 11 Years

Eligibility

Inclusion Criteria:

• Patients from 3 to 11 years suffering from a clinically relevant Dermatophagoides farinae and Dermatophagoides pteronyssinus induced allergic rhinitis or rhinoconjunctivitis associated with or not with asthma

• Positive skin testing

• Positive Serum-Specific IgE determination

• Parental or legal representative informed consent

• Clinical sintomatology on the inclusion period

Exclusion Criteria:

• Patients suffering from acute or chronic infections or inflammations

• Patients suffering from uncontrolled and severe 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 house dust mites
Adminstration of Beltavac® Polymerized with house dust mites according to the routine clinical practice

Locations

Country	Name	City	State
Spain	Teknon Medical Center	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Alfons Malet i Casajuana	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		1 Year
Secondary	Combined symtom and medication score of Rhinoconjunctivitis	The score will be calculated as a sum of the symptoms score (0-3) and medication score (0-3)	1 Year
Secondary	Combined symtom and medication score of Asthma	The score will be calculated as a sum of the symptoms score (0-3) and medication score (0-3)	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		1 Year