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

Study Overview

• Status: Completed
• Conditions: Allergic Rhinoconjunctivitis
• Intervention / Treatment: Biological: Alutard phleum pratense subcutaneous immunotherapy; Drug: Alutard phl prat

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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Alutard 225, phleum pratense, ALK-abelló

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
a significant decrease in basophil activity during and after treatment	every 3 weeks for 3 months, then 3 monthly for 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
reduction in high affinity IgE receptor density on basophils and mast cells	igE receptor density on basophils and mast cells from nasal mucosa	at inclusion and at the end of study
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	once yearly for 4 years
a significant increase in the number of plasma cells during up dosing		5 times during the first 3 months of the study
a significant shift in specific immunoglobulins from IgE at start to IgG1 and IgG4 after treatment. allergen epitope specific IgE and IgG4		every 3 months for 4 years

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: March 10, 2010
• First Submitted That Met QC Criteria: March 11, 2010
• First Posted (Estimate): March 12, 2010

Study Record Updates

• Last Update Posted (Estimate): February 18, 2015
• Last Update Submitted That Met QC Criteria: February 16, 2015
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: IgE; grass pollen allergy; plasma cells; basophil activity; IgG1; IgG4; mast cells; IgE receptor; allergic rhinoconjunctivitis
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Physiological Effects of Drugs; Immunologic Factors
• Other Study ID Numbers: BasoScit