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Completed

NCT Number: NCT01085526

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

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

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Key information

Conditions

Allergic Rhinoconjunctivitis

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alutard phleum pratense subcutaneous immunotherapy

Biological

standard regimen of SCIT

Other names: alutard phleum pratense, subcutaneous immunotherapy

Alutard phl prat

Drug

Other names: Alutard 225, phleum pratense, ALK-abelló

Primary outcomes

  1. 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 outcomes

  1. reduction in high affinity IgE receptor density on basophils and mast cells

    Time frame: at inclusion and at the end of study

    igE receptor density on basophils and mast cells from nasal mucosa

  2. 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

    allergen challenging response

  3. a significant increase in the number of plasma cells during up dosing

    Time frame: 5 times during the first 3 months of the study

  4. 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

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • ALK-Abelló A/S
  • Lundbeck Foundation
  • University of Aarhus

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Mar 12, 2010
Registry last updated
Feb 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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