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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Aarhus
ALK-Abelló A/S
Lundbeck Foundation
Information provided by (Responsible Party):
Pia Pedersen, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT01085526
First received: March 10, 2010
Last updated: July 4, 2014
Last verified: July 2014

March 10, 2010
July 4, 2014
February 2010
July 2014   (final data collection date for primary outcome measure)
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 ]
  • changes in basophil activity [ Time Frame: 3 weeks in 3 months, then 3 monthly for 3 years ] [ Designated as safety issue: No ]
  • changes in immunoglobulin concentrations [ Time Frame: every 3 months for 4 years ] [ Designated as safety issue: No ]
  • plasma cells [ Time Frame: 5 times in 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01085526 on ClinicalTrials.gov Archive Site
  • 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 ]
  • IgE receptor [ 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 [ Time Frame: once yearly for 4 years ] [ Designated as safety issue: No ]
    allergen challgenging response
Not Provided
Not Provided
 
Changes in Specific Immunoglobulin and Blood Basophil Activity During Subcutaneous Immunotherapy in Allergic Rhinitis
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

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

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
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Allergic Rhinoconjunctivitis
  • Biological: Alutard phleum pratense subcutaneous immunotherapy
    standard regimen of SCIT
    Other Names:
    • alutard phleum pratense
    • subcutaneous immunotherapy
  • Drug: Alutard phl prat
    Other Name: Alutard 225, phleum pratense, ALK-abelló
  • Active Comparator: alutard phl prat. treatment group
    18 subjects receiving active treatment: basophil activity, plasma cells and immunoglobulins measured
    Interventions:
    • Biological: Alutard phleum pratense subcutaneous immunotherapy
    • Drug: Alutard phl prat
  • No Intervention: control group
    control
  • Active Comparator: alutard phl.prat., treatment group2
    basophil activity, basophil biology measured
    Interventions:
    • Biological: Alutard phleum pratense subcutaneous immunotherapy
    • Drug: Alutard phl prat
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
September 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01085526
BasoScit
Yes
Pia Pedersen, Aarhus University Hospital
Aarhus University Hospital
  • University of Aarhus
  • ALK-Abelló A/S
  • Lundbeck Foundation
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
Aarhus University Hospital
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP