Non-interventional Study to Assess the Tolerability and the Safety Profile of SCIT Therapy With Acarovac® Hausstaubmilbe

A Prospective, Open, Non-interventional Study to Assess the Tolerability and the Safety Profile of SCIT Therapy With Acarovac® Hausstaubmilbe in Patients With HDM-induced Rhinoconjunctivitis With or Without Allergic Asthma

Non-interventional Study to Assess the Tolerability and the Safety Profile of SCIT therapy With Acarovac® Hausstaubmilbe

Study Overview

• Status: Completed
• Conditions: Perennial Allergic Rhinitis
• Intervention / Treatment: Drug: Acarovac

Detailed Description

This prospective open multi-centre non-interventional study was initiated to document the tolerability and the safety profile of the subcutaneous allergen-specific immunotherapy with Acarovac® in house dust mite allergic patients in routine medical care.

During the up-dosing phase with Acarovac®, patients will receive 4 injections in 1-2 week intervals with increasing allergen amount up to the individual maximum tolerable dose. After reaching the individual maximum tolerable dose patients will receive one maintenance dose in a 4 - 8 week interval.

Data on tolerability are documented by the physicians.

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• Austria
  • Wien, Austria, 1230
    • Praxis für Lungenheilkunde

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adults, adolescents and children from the age of 5 on, who suffer from perenial allergic rhinoconjunctivitis causued by house dust mites.

Description

Inclusion Criteria:

• Patients of the age of 5 years and older suffering from a house dust mite induced allergic rhinitis

Exclusion Criteria:

• Patients suffering from acute or chronic infections or inflammations
• Patients suffering from secondary modifications of the target organ with function impairment (emphysema, bronchiectasis)
• Patients suffering from severe and uncontrolled asthma
• Patients with a known severe autoimmune disease
• Patients with active malignant disease
• Patients requiring beta-blockers
• Patients having any contraindication for the use of adrenaline
• Patients with a hypersensitivity to the excipients of the drug

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Acarovac Hausstaubmilbe; This prospective open multi-centre non-interventional study was initiated to document the tolerability and the safety profile of the subcutaneous allergen-specific immunotherapy with Acarovac in house dust mite allergic patients (children and adults) in routine medical care. During the up-dosing phase with Acarovac, patients will receive 4 injections in 1-2 week intervals with increasing allergen amount up to the individual maximum tolerable dose. After reaching the individual maximum tolerable dose patients will receive one maintenance dose in a 4 - 8 week interval. Data on tolerability are documented by the physicians.

Drug: Acarovac; House dust mite sensitized Patients receive increasing doses of subcutaneous immunotherapy with Acarovac. During the up-dosing phase, patients will receive 4 injections in 1-2 week intervals with increasing allergen amount up to the individual maximum tolerable dose. After reaching the individual maximum tolerable dose patients will receive one maintenance dose in a 4 - 8 week interval.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numbers of treatment-related local and systemic reactions following SCIT administration	Tolerability and safety will be assessed by the frequency and intensity of local reactions at the injection site (wheal size 5-10 cm, > 10 cm ) and systemic reactions (skin, airways, others) through study completion. The study covers the four injections of the up-dosing phase and one injection of the maintenance phase of the immunotherapy course.	over the overall duration of the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability - frequency and intensity of adverse events	Frequency and intensity of adverse events	over the overall duration of the study
Safety and Tolerability - local reactions at injection site	Frequency and intensity of local reactions at the injection site (wheal size 5-10 cm, > 10 cm )	over the overall duration of the study
Safety and Tolerability - Number of systemic reactions	Frequency and intensity of systemic reactions	over the overall duration of the study
Changes in rhinoconjunctivitis score	The rhinoconjunctivitis score combines rhinitis symptom intensity and conjunctivitis symptom intensity and will be assessed retrospectively and after the course of treatment	baseline and 3-6 month, depending on the intervals between the injections and the applied up-dosing scheme

Collaborators and Investigators

• Sponsor: University Hospital of Cologne
• Collaborators: Bencard Allergie GmbH

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): February 14, 2019
• Study Completion (Actual): February 14, 2019

Study Registration Dates

• First Submitted: April 13, 2017
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (Actual): April 25, 2017

Study Record Updates

• Last Update Posted (Actual): April 24, 2019
• Last Update Submitted That Met QC Criteria: April 23, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
• Other Study ID Numbers: Acarovac AT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No