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

Primary Purpose

Allergic Rhinoconjunctivitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Alutard phleum pratense subcutaneous immunotherapy
Alutard phl prat
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Allergic Rhinoconjunctivitis focused on measuring basophil activity, plasma cells, IgE, IgG1, IgG4, mast cells, IgE receptor, allergic rhinoconjunctivitis, grass pollen allergy

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    No Intervention

    Active Comparator

    Arm Label

    alutard phl prat. treatment group

    control group

    alutard phl.prat., treatment group2

    Arm Description

    18 subjects receiving active treatment: basophil activity, plasma cells and immunoglobulins measured

    control

    basophil activity, basophil biology measured

    Outcomes

    Primary Outcome Measures

    a significant decrease in basophil activity during and after treatment

    Secondary Outcome Measures

    reduction in high affinity IgE receptor density on basophils and mast cells
    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
    allergen challenging response
    a significant increase in the number of plasma cells during up dosing
    a significant shift in specific immunoglobulins from IgE at start to IgG1 and IgG4 after treatment. allergen epitope specific IgE and IgG4

    Full Information

    First Posted
    March 10, 2010
    Last Updated
    February 16, 2015
    Sponsor
    Aarhus University Hospital
    Collaborators
    University of Aarhus, ALK-Abelló A/S, Lundbeck Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01085526
    Brief Title
    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

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2010 (undefined)
    Primary Completion Date
    July 2014 (Actual)
    Study Completion Date
    September 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Aarhus University Hospital
    Collaborators
    University of Aarhus, ALK-Abelló A/S, Lundbeck Foundation

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Allergic Rhinoconjunctivitis
    Keywords
    basophil activity, plasma cells, IgE, IgG1, IgG4, mast cells, IgE receptor, allergic rhinoconjunctivitis, grass pollen allergy

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    alutard phl prat. treatment group
    Arm Type
    Active Comparator
    Arm Description
    18 subjects receiving active treatment: basophil activity, plasma cells and immunoglobulins measured
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    control
    Arm Title
    alutard phl.prat., treatment group2
    Arm Type
    Active Comparator
    Arm Description
    basophil activity, basophil biology measured
    Intervention Type
    Biological
    Intervention Name(s)
    Alutard phleum pratense subcutaneous immunotherapy
    Other Intervention Name(s)
    alutard phleum pratense, subcutaneous immunotherapy
    Intervention Description
    standard regimen of SCIT
    Intervention Type
    Drug
    Intervention Name(s)
    Alutard phl prat
    Other Intervention Name(s)
    Alutard 225, phleum pratense, ALK-abelló
    Primary Outcome Measure Information:
    Title
    a significant decrease in basophil activity during and after treatment
    Time Frame
    every 3 weeks for 3 months, then 3 monthly for 3 years
    Secondary Outcome Measure Information:
    Title
    reduction in high affinity IgE receptor density on basophils and mast cells
    Description
    igE receptor density on basophils and mast cells from nasal mucosa
    Time Frame
    at inclusion and at the end of study
    Title
    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
    Description
    allergen challenging response
    Time Frame
    once yearly for 4 years
    Title
    a significant increase in the number of plasma cells during up dosing
    Time Frame
    5 times during the first 3 months of the study
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ronald Dahl, Prof, dr.med
    Organizational Affiliation
    Dept. of Respiratory Medicine, Århus University Hospital
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Hans Juergen Hoffmann, assoc prof
    Organizational Affiliation
    Dept of Respiratory Medicine, Århus University Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Johannes M Schmid, MD
    Organizational Affiliation
    Dept. of Respiratory Medicine, Aarhus University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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

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