Changes in Specific Immunoglobulin and Blood Basophil Activity During Subcutaneous Immunotherapy in Allergic Rhinitis - Full Text View

Purpose

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

Condition	Intervention
Allergic Rhinoconjunctivitis	Biological: Alutard phleum pratense subcutaneous immunotherapy Biological: no treatment

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science
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

Resource links provided by NLM:

MedlinePlus related topics: Allergy Hay Fever

Drug Information available for: Phleum pratense

U.S. FDA Resources

Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:

a significant decrease in basophil activity during and after treatment [ Time Frame: every 3 weeks for 3 months, then 3 monthly for 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

reduction in high affinity IgE receptor density on basophils and mast cells [ Time Frame: at inclusion and at the end of study ] [ Designated as safety issue: No ]
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 [ Time Frame: once yearly for 4 years ] [ Designated as safety issue: No ]
allergen challenging response
a significant increase in the number of plasma cells during up dosing [ Time Frame: 5 times during the first 3 months of the study ] [ Designated as safety issue: No ]
a significant shift in specific immunoglobulins from IgE at start to IgG1 and IgG4 after treatment. allergen epitope specific IgE and IgG4 [ Time Frame: every 3 months for 4 years ] [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	February 2010
Estimated Study Completion Date:	September 2014
Estimated Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: alutard phl prat. treatment group: plasma cells 18 subjects receiving active treatment: basophil activity, plasma cells and immunoglobulins measured	Biological: Alutard phleum pratense subcutaneous immunotherapy standard regimen of SCIT Other Names: alutard phleum pratense subcutaneous immunotherapy
No Intervention: control control group: basophil activity, basophil biology, plasma cells	Biological: no treatment no treatment
Active Comparator: alutard phl.prat., treatment2, basophil biology basophil activity, basophil biology measured	Biological: Alutard phleum pratense subcutaneous immunotherapy standard regimen of SCIT Other Names: alutard phleum pratense subcutaneous immunotherapy

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

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01085526

Sponsors and Collaborators

Aarhus University Hospital

University of Aarhus

ALK-Abelló A/S

Lundbeck Foundation

Investigators

Study Chair:	Ronald Dahl, Prof, dr.med	Dept. of Respiratory Medicine, Århus University Hospital
Principal Investigator:	Hans Juergen Hoffmann, assoc prof	Dept of Respiratory Medicine, Århus University Hospital
Principal Investigator:	Johannes M Schmid, MD	Dept. of Respiratory Medicine, Aarhus University Hospital

More Information

No publications provided

Responsible Party:	Prof. Dr, med Ronald Dahl, Department of Respiratory Medicine, Århus University Hospital, Århus, Denmark, Århus University Hospital
ClinicalTrials.gov Identifier:	NCT01085526 History of Changes
Other Study ID Numbers:	BasoScit
Study First Received:	March 10, 2010
Last Updated:	June 24, 2011
Health Authority:	Denmark: The National Committee of Biomedical Research Ethics

Keywords provided by Aarhus University Hospital:

basophil activity
plasma cells
IgE
IgG1
IgG4

mast cells
IgE receptor
allergic rhinoconjunctivitis
grass pollen allergy

Additional relevant MeSH terms:

Rhinitis, Allergic, Seasonal
Rhinitis
Conjunctivitis, Allergic
Conjunctivitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity

Immune System Diseases
Respiratory Tract Infections
Conjunctival Diseases
Eye Diseases
Immunoglobulins
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013