Changes in Specific Immunoglobulin and Blood Basophil Activity During Subcutaneous Immunotherapy in Allergic Rhinitis
NCT ID: NCT01085526
Last Updated: 2015-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2010-02-28
2014-09-30
Brief Summary
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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
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Detailed Description
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* 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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alutard phl prat. treatment group
18 subjects receiving active treatment: basophil activity, plasma cells and immunoglobulins measured
Alutard phleum pratense subcutaneous immunotherapy
standard regimen of SCIT
Alutard phl prat
control group
control
No interventions assigned to this group
alutard phl.prat., treatment group2
basophil activity, basophil biology measured
Alutard phleum pratense subcutaneous immunotherapy
standard regimen of SCIT
Alutard phl prat
Interventions
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Alutard phleum pratense subcutaneous immunotherapy
standard regimen of SCIT
Alutard phl prat
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* positive skin prick test and nasal allergen challenge test to grass pollen extract
Exclusion Criteria
18 Years
40 Years
ALL
No
Sponsors
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University of Aarhus
OTHER
ALK-Abelló A/S
INDUSTRY
Lundbeck Foundation
OTHER
Aarhus University Hospital
OTHER
Responsible Party
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Pia Pedersen
MD
Principal Investigators
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Ronald Dahl, Prof, dr.med
Role: STUDY_CHAIR
Dept. of Respiratory Medicine, Århus University Hospital
Hans Juergen Hoffmann, assoc prof
Role: PRINCIPAL_INVESTIGATOR
Dept of Respiratory Medicine, Århus University Hospital
Johannes M Schmid, MD
Role: PRINCIPAL_INVESTIGATOR
Dept. of Respiratory Medicine, Aarhus University Hospital
Other Identifiers
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BasoScit
Identifier Type: -
Identifier Source: org_study_id
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