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The aim of this study is to test the pharmacodynamic equivalence with respect to IgE-blocking factor and to compare the tolerability of two different updosing schedules with ALK-Flex SQ
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| subcutaneous immunotherapy | Active Comparator | subcutaneous immunotherapy using a slow updosing schedule |
|
| subcutaneous injections | Active Comparator | subcutaneous immunotherapy using a fast updosing schedule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| subcutaneous immunotherapy | Biological | 7 injections |
|
| Measure | Description | Time Frame |
|---|---|---|
| IgE-blocking factor | start of treatment and 1 week after end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of two different updosing schedules | throughout treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kirsten Jung, MD | Private practice, Erfurt, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergists' practice Dr. Kirsten Jung | Erfurt | Thuringia | D-99084 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22385366 | Result | Pfaar O, Jung K, Wolf H, Decot E, Kleine-Tebbe J, Klimek L, Wustenberg E. Immunological effects and tolerability of a new fast updosed immunologically enhanced subcutaneous immunotherapy formulation with optimized allergen/adjuvant ratio. Allergy. 2012 May;67(5):630-7. doi: 10.1111/j.1398-9995.2012.02801.x. Epub 2012 Mar 3. |
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| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D003231 | Conjunctivitis |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| D010038 |
| Otorhinolaryngologic Diseases |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |