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

Not Applicable

Completed

• Conditions: Allergic Rhinoconjunctivitis
• Interventions: Biological: Alutard phleum pratense subcutaneous immunotherapy; Drug: Alutard phl prat

• Registration Number: NCT01085526
• Lead Sponsor: Aarhus University Hospital

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

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-03-10
• Study First Submitted QC: 2010-03-11
• Study First Posted: 2010-03-12
• Status Verified: 2014-07
• Primary Completion: 2014-07
• Study Completion: 2014-09
• Last Update Submitted: 2015-02-16
• Last Update Posted: 2015-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
alutard phl prat. treatment group	Alutard phleum pratense subcutaneous immunotherapy	18 subjects receiving active treatment: basophil activity, plasma cells and immunoglobulins measured
alutard phl.prat., treatment group2	Alutard phl prat	basophil activity, basophil biology measured
alutard phl prat. treatment group	Alutard phl prat	18 subjects receiving active treatment: basophil activity, plasma cells and immunoglobulins measured
alutard phl.prat., treatment group2	Alutard phleum pratense subcutaneous immunotherapy	basophil activity, basophil biology measured

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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