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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
  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
Drug: Alutard phl prat

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:


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
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: alutard phl prat. treatment group
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
Drug: Alutard phl prat
Other Name: Alutard 225, phleum pratense, ALK-abelló
No Intervention: control group
control
Active Comparator: alutard phl.prat., treatment group2
basophil activity, basophil biology measured
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Pia Pedersen, MD, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01085526     History of Changes
Other Study ID Numbers: BasoScit
Study First Received: March 10, 2010
Last Updated: July 4, 2014
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:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014