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| Name | Class |
|---|---|
| Bencard Allergie GmbH | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acarovac | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adults, adolescents and children from the age of 5 on, who suffer from perenial allergic rhinoconjunctivitis causued by house dust mites.
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| Name | Affiliation | Role |
|---|---|---|
| Matthias Kramer, Prof. Dr. | Bencard Allergie GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Praxis für Lungenheilkunde | Vienna | 1230 | Austria |
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| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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|
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 |
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |