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

University Hospital of Cologne32 enrolled

Overview

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

Conditions

Perennial Allergic Rhinitis

Interventions

AcarovacDRUG

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.

Eligibility

Sex: ALLMin age: 5 Years

Medical Language ↔ Plain English

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

Locations (1)

Praxis für Lungenheilkunde

Vienna, Austria

Outcomes

Primary Outcomes

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.

Time frame: over the overall duration of the study

Secondary Outcomes

Safety and Tolerability - frequency and intensity of adverse events

Frequency and intensity of adverse events

Time frame: 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 )

Time frame: over the overall duration of the study

Safety and Tolerability - Number of systemic reactions

Frequency and intensity of systemic reactions

Time frame: 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

Time frame: baseline and 3-6 month, depending on the intervals between the injections and the applied up-dosing scheme

Data from ClinicalTrials.gov

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