Perennial Allergic Rhinitis
Conditions
Brief summary
Non-interventional Study to Assess the Tolerability and the Safety Profile of SCIT therapy With Acarovac® Hausstaubmilbe
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.
Interventions
DRUGAcarovac
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.
Sponsors
Bencard Allergie GmbH
University Hospital of Cologne
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numbers of treatment-related local and systemic reactions following SCIT administration | over the overall duration of the study | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability - frequency and intensity of adverse events | over the overall duration of the study | Frequency and intensity of adverse events |
| Safety and Tolerability - local reactions at injection site | over the overall duration of the study | Frequency and intensity of local reactions at the injection site (wheal size 5-10 cm, \> 10 cm ) |
| Safety and Tolerability - Number of systemic reactions | over the overall duration of the study | Frequency and intensity of systemic reactions |
| Changes in rhinoconjunctivitis score | baseline and 3-6 month, depending on the intervals between the injections and the applied up-dosing scheme | The rhinoconjunctivitis score combines rhinitis symptom intensity and conjunctivitis symptom intensity and will be assessed retrospectively and after the course of treatment |
Countries
Austria
Outcome results
None listed