Allergic Rhinoconjunctivitis
Conditions
Keywords
basophil activity, plasma cells, IgE, IgG1, IgG4, mast cells, IgE receptor, allergic rhinoconjunctivitis, grass pollen allergy
Brief 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
Detailed 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
Interventions
BIOLOGICALAlutard phleum pratense subcutaneous immunotherapy
standard regimen of SCIT
DRUGAlutard phl prat
Sponsors
University of Aarhus
ALK-Abelló A/S
Lundbeck Foundation
Aarhus University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* rhinoconjunctivitis due to grass pollen allergy * positive skin prick test and nasal allergen challenge test to grass pollen extract
Exclusion criteria
* severe comorbidity, severe asthma, pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a significant decrease in basophil activity during and after treatment | every 3 weeks for 3 months, then 3 monthly for 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| reduction in high affinity IgE receptor density on basophils and mast cells | at inclusion and at the end of study | igE receptor density on basophils and mast cells from nasal mucosa |
| 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 | once yearly for 4 years | allergen challenging response |
| a significant increase in the number of plasma cells during up dosing | 5 times during the first 3 months of the study | — |
Outcome results
None listed