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| Name | Class |
|---|---|
| University of Aarhus | OTHER |
| ALK-Abelló A/S | INDUSTRY |
| Lundbeck Foundation | OTHER |
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The trial is randomized prospective study to examine the effects of subcutaneous immunotherapy on the adaptive immune system. The trial includes 30 participants randomized to treatment or control group. The effect measures are changes in the basophil activity and biology as well as changes in plasma cells during and after treatment. Clinical outcome is assessed by QoL questionnaires and clinical testing.
Hypotheses:
The investigators are recruiting 30 participants, which are randomized to receive SCIT (24) or no treatment (6) The following will be measured
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| alutard phl prat. treatment group | Active Comparator | 18 subjects receiving active treatment: basophil activity, plasma cells and immunoglobulins measured |
|
| control group | No Intervention | control | |
| alutard phl.prat., treatment group2 | Active Comparator | basophil activity, basophil biology measured |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alutard phleum pratense subcutaneous immunotherapy | Biological | standard regimen of SCIT |
|
| Measure | Description | Time Frame |
|---|---|---|
| a significant decrease in basophil activity during and after treatment | every 3 weeks for 3 months, then 3 monthly for 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| reduction in high affinity IgE receptor density on basophils and mast cells | igE receptor density on basophils and mast cells from nasal mucosa | at inclusion and at the end of study |
| clinical outcome: reduction in the reaction to allergen challenge tests (skin and nose), significant better outcome in quality of life questionnaires and symptom/medication scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Dahl, Prof, dr.med | Dept. of Respiratory Medicine, Århus University Hospital | Study Chair |
| Hans Juergen Hoffmann, assoc prof | Dept of Respiratory Medicine, Århus University Hospital | Principal Investigator |
| Johannes M Schmid, MD | Dept. of Respiratory Medicine, Aarhus University Hospital | Principal Investigator |
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|
| Alutard phl prat | Drug |
|
|
allergen challenging response |
| once yearly for 4 years |
| a significant increase in the number of plasma cells during up dosing | 5 times during the first 3 months of the study |
| a significant shift in specific immunoglobulins from IgE at start to IgG1 and IgG4 after treatment. allergen epitope specific IgE and IgG4 | every 3 months for 4 years |