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

Allergic Rhinoconjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01085526
• Other study ID #: BasoScit
• Status: Completed
• Phase: N/A
• First received: March 10, 2010
• Last updated: February 16, 2015
• Start date: February 2010
• Est. completion date: September 2014

Study information

• Verified date: July 2014
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The National Committee of Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Allergic Rhinoconjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Biological:
• Alutard phleum pratense subcutaneous immunotherapy
standard regimen of SCIT

Drug:
• Alutard phl prat

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Aarhus University Hospital	ALK-Abelló A/S, Lundbeck Foundation, University of Aarhus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	a significant decrease in basophil activity during and after treatment		every 3 weeks for 3 months, then 3 monthly for 3 years	No
Secondary	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	No
Secondary	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	No
Secondary	a significant increase in the number of plasma cells during up dosing		5 times during the first 3 months of the study	No
Secondary	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	No