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Clinical Trial Summary

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:

- changes in plasma cells correlate to changes in immunoglobulins and effector cell responses

- the reduction of inflammation due to SCIT has influence on the effector cell responses

- changes in paraclinical measurements can be related to clinical findings


Clinical Trial Description

The investigators are recruiting 30 participants, which are randomized to receive SCIT (24) or no treatment (6) The following will be measured

- the development of immunoglobulin response

- plasma cells under updosing phase

- changes in basophil activity under updosing and maintenance treatment

- subtyping of allergic sensitization

- clinical outcome and quality of life

- changes in mast cells in the nasal mucosa

- changes in the cell biology of the basophils ;


Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


NCT number NCT01085526
Study type Interventional
Source Aarhus University Hospital
Contact
Status Completed
Phase N/A
Start date February 2010
Completion date September 2014

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