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

Aarhus University Hospital

Status: Completed

Conditions: Allergic Rhinoconjunctivitis

Treatments: Drug: Alutard phl prat; Biological: Alutard phleum pratense subcutaneous immunotherapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01085526

BasoScit

Details and patient eligibility

About

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

Full 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

Enrollment: 30 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

alutard phl prat. treatment group

Active Comparator group

Description:

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

Treatment:

Biological: Alutard phleum pratense subcutaneous immunotherapy

Drug: Alutard phl prat

control group

No Intervention group

Description:

control

alutard phl.prat., treatment group2

Active Comparator group

Description:

basophil activity, basophil biology measured

Treatment:

Biological: Alutard phleum pratense subcutaneous immunotherapy

Drug: Alutard phl prat