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

NCT01085526 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-02-18

No results posted yet for this study

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

Interventions

BIOLOGICAL

Alutard phleum pratense subcutaneous immunotherapy

standard regimen of SCIT

DRUG

Alutard phl prat

Sponsors & Collaborators

  • University of Aarhus

    collaborator OTHER

  • ALK-Abelló A/S

    collaborator INDUSTRY

  • Lundbeck Foundation

    collaborator OTHER

  • Aarhus University Hospital

    lead OTHER

Principal Investigators

  • Ronald Dahl, Prof, dr.med · Dept. of Respiratory Medicine, Århus University Hospital

  • Hans Juergen Hoffmann, assoc prof · Dept of Respiratory Medicine, Århus University Hospital

  • Johannes M Schmid, MD · Dept. of Respiratory Medicine, Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2014-07-31
Completion
2014-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01085526 on ClinicalTrials.gov