Clinical trial NCT01085526: Changes in Specific Immunoglobulin and Blood Basophil Activity During Subcutaneous Immunotherapy in Allergic Rhinitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Rhinoconjunctivitis
Keywords: basophil activity
plasma cells
IgE
IgG1
IgG4
mast cells
IgE receptor
allergic rhinoconjunctivitis
grass pollen allergy
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: University of Aarhus
name: ALK-Abelló A/S
name: Lundbeck Foundation
First posted: 2010-03-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

Eligibility criteria: 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

Primary outcomes:
measure: a significant decrease in basophil activity during and after treatment
timeFrame: every 3 weeks for 3 months, then 3 monthly for 3 years
Secondary outcomes:
measure: reduction in high affinity IgE receptor density on basophils and mast cells
timeFrame: at inclusion and at the end of study
measure: 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
timeFrame: once yearly for 4 years
measure: a significant increase in the number of plasma cells during up dosing
timeFrame: 5 times during the first 3 months of the study
measure: a significant shift in specific immunoglobulins from IgE at start to IgG1 and IgG4 after treatment. allergen epitope specific IgE and IgG4
timeFrame: every 3 months for 4 years
Other outcomes:
Locations:
Study officials:
affiliation: Dept. of Respiratory Medicine, Århus University Hospital
name: Ronald Dahl, Prof, dr.med
role: STUDY_CHAIR
affiliation: Dept of Respiratory Medicine, Århus University Hospital
name: Hans Juergen Hoffmann, assoc prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Respiratory Medicine, Aarhus University Hospital
name: Johannes M Schmid, MD
role: PRINCIPAL_INVESTIGATOR
References: