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

NCT01085526 | Completed DMC

• 1 other identifier: BasoScit
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Allergic Rhinoconjunctivitis

Keywords

basophil activity; plasma cells; IgE; IgG1; IgG4; mast cells; IgE receptor; allergic rhinoconjunctivitis; grass pollen allergy

Outcome Measures

Primary Outcomes (1)

• a significant decrease in basophil activity during and after treatment

  every 3 weeks for 3 months, then 3 monthly for 3 years

Secondary Outcomes (4)

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

  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

  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

Study Arms (3)

alutard phl prat. treatment group

ACTIVE COMPARATOR

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

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

control group

NO INTERVENTION

control

alutard phl.prat., treatment group2

ACTIVE COMPARATOR

basophil activity, basophil biology measured

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

Interventions

Alutard phleum pratense subcutaneous immunotherapy BIOLOGICAL

standard regimen of SCIT

Also known as: alutard phleum pratense, subcutaneous immunotherapy

alutard phl prat. treatment group; alutard phl.prat., treatment group2

Alutard phl prat DRUG

Also known as: Alutard 225, phleum pratense, ALK-abelló

alutard phl prat. treatment group; alutard phl.prat., treatment group2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• rhinoconjunctivitis due to grass pollen allergy
• positive skin prick test and nasal allergen challenge test to grass pollen extract

You may not qualify if:

• severe comorbidity, severe asthma, pregnancy

Sponsors & Collaborators

• Aarhus University Hospital: lead
• University of Aarhus: collaborator
• ALK-Abelló A/S: collaborator
• Lundbeck Foundation: collaborator

Study Officials

• Ronald Dahl, Prof, dr.med

  Dept. of Respiratory Medicine, Århus University Hospital

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 10, 2010
• First Posted: March 12, 2010
• Study Start: February 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: September 1, 2014
• Last Updated: February 18, 2015

Record last verified: 2014-07