Changes in Specific Immunoglobulin and Blood Basophil Activity During Subcutaneous Immunotherapy in Allergic Rhinitis

Study Overview
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Brief Summary
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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: 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
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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

Official Title
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Changes in Specific Immunoglobulin and Blood Basophil Activity During Subcutaneous Immunotherapy in Patients With Allergic Rhinitis Due to Grass Pollen Allergy - a Prospective Randomized Controlled Study

Conditions
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Allergic Rhinoconjunctivitis

Intervention / Treatment
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* Biological: Alutard phleum pratense subcutaneous immunotherapy
* Drug: Alutard phl prat


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: alutard phl prat. treatment group<br>18 subjects receiving active treatment: basophil activity, plasma cells and immunoglobulins measured | Biological: Alutard phleum pratense subcutaneous immunotherapy<br>* standard regimen of SCIT<br>* Other names: subcutaneous immunotherapy;Drug: Alutard phl prat<br> <br> * Other names: Alutard 225, phleum pratense, ALK-abelló;|
| No Intervention: control group<br>control | |
| Active Comparator: alutard phl.prat., treatment group2<br>basophil activity, basophil biology measured | Biological: Alutard phleum pratense subcutaneous immunotherapy<br>* standard regimen of SCIT<br>* Other names: subcutaneous immunotherapy;Drug: Alutard phl prat<br> <br> * Other names: Alutard 225, phleum pratense, ALK-abelló;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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basophil activity, plasma cells, IgE, IgG1, IgG4, mast cells, IgE receptor, allergic rhinoconjunctivitis, grass pollen allergy