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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Perennial Allergic Rhinitis

Intervention / Treatment
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* Drug: Acarovac


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acarovac Hausstaubmilbe<br>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<br>* 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.<br>|

What is the study measuring?
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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 |