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

NCT ID: NCT01085526

Last Updated: 2015-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2014-09-30

Brief Summary

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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

Detailed Description

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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

Conditions

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Allergic Rhinoconjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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alutard phl prat. treatment group

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

Group Type ACTIVE_COMPARATOR

Alutard phleum pratense subcutaneous immunotherapy

Intervention Type BIOLOGICAL

standard regimen of SCIT

Alutard phl prat

Intervention Type DRUG

control group

control

Group Type NO_INTERVENTION

No interventions assigned to this group

alutard phl.prat., treatment group2

basophil activity, basophil biology measured

Group Type ACTIVE_COMPARATOR

Alutard phleum pratense subcutaneous immunotherapy

Intervention Type BIOLOGICAL

standard regimen of SCIT

Alutard phl prat

Intervention Type DRUG

Interventions

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Alutard phleum pratense subcutaneous immunotherapy

standard regimen of SCIT

Intervention Type BIOLOGICAL

Alutard phl prat

Intervention Type DRUG

Other Intervention Names

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alutard phleum pratense subcutaneous immunotherapy Alutard 225, phleum pratense, ALK-abelló

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role collaborator

ALK-Abelló A/S

INDUSTRY

Sponsor Role collaborator

Lundbeck Foundation

OTHER

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Pia Pedersen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ronald Dahl, Prof, dr.med

Role: STUDY_CHAIR

Dept. of Respiratory Medicine, Århus University Hospital

Hans Juergen Hoffmann, assoc prof

Role: PRINCIPAL_INVESTIGATOR

Dept of Respiratory Medicine, Århus University Hospital

Johannes M Schmid, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Respiratory Medicine, Aarhus University Hospital

Other Identifiers

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BasoScit

Identifier Type: -

Identifier Source: org_study_id

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