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A Trial o Immunological Outcomes of Sublingual Immunotherapy for House Dust Mite (D. Pteronyssinus) Allergy.
This study is not yet open for participant recruitment.
Verified by Bayside Health, November 2005
Sponsored by: Bayside Health
Information provided by: Bayside Health
ClinicalTrials.gov Identifier: NCT00250263
  Purpose

Allergic diseases represent a major health issue worldwide. Mainstay treatment is allergen avoidance and pharmacotherapy for symptom relief. Allergen immunotherapy offers the advantages of specific treatment with long lasting efficacy, and can modify the course of disease. However, use of this treatment is restricted by the high risk of adverse events especially in asthmatics. Other, better tolerated, routes of allergen administration than the current conventional subcutaneous route (SCIT) have been investigated including sublingual (SLIT). However, the immune parameters of SLIT have not been examined. We propose conducting a randomised, placebo-controlled study of a commercially-available SLIT for house dust mite (HDM) allergy to investigate induction of relevant T cell regulatory immune mechanisms. Immunoregulatory cytokine synthesis and T cell phenotype and function (real time PCR and flow cytometry) will be examined. This project will provide important fundamental knowledge on which to base improved and greater application of this potentially curative treatment for allergy. SLIT has the potential advantage of home administration and suitability for patients with asthma who are currently unable to access many of the allergen desensitising regimens.


Condition Intervention Phase
Allergic Rhinitis
Asthma
Drug: (agent for immunotherapy) Staloral
Phase IV

MedlinePlus related topics: Allergy Asthma
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title: A Trial o Immunological Outcomes of Sublingual Immunotherapy for House Dust Mite (D. Pteronyssinus) Allergy.

Further study details as provided by Bayside Health:

Primary Outcome Measures:
  • Immunological mechanisms of SLIT by phenotyping different subsets of cytokine positive T cells, regulatory T cells, and memory T cells in peripheral blood of subjects before, during and after immunotherapy.
  • -Expression of “immunoregulatory” cytokines by CD4+ T
  • cells
  • - Helper, regulatory and memory T cell subsets
  • (a) Helper T cells
  • (b) Regulatory T cells
  • b1- Regulatory T cell phenotype
  • b2- Regulatory T cell function

Secondary Outcome Measures:
  • Symptom diary, medication use, visual analogue score, disease-specific rhinoconjunctivitis Quality of Life Questionnaire

Estimated Enrollment: 30
Study Start Date: November 2005
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • allergic rhinitis and/or
  • mild stable asthma
  • house dust mite allergic
  • positive HDM-specific IgE as determined by skin prick test (wheal diameter >6 mm to D. pteronyssinus) or CAP-Pharmacia score > 2

Exclusion Criteria:

  • Immunodeficiency diseases
  • Severe or uncontrolled asthma
  • Previous immunotherapy with House dust mite (HDM) extract within the last five years or ongoing immunotherapy with HDM or other allergens
  • Continuous oral corticosteroids
  • Subjects on treatment with beta-blockers
  • Pregnant women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00250263

Contacts
Contact: Alessandra Sandrini, MD, PhD +61 3 9276 2000 ext 2350 a.sandrini@alfred.org.au
Contact: Kirsten Deckert +61 3 9276 2000 ext 3710

Locations
Australia, Victoria
The Alfred Hospital. Department of Allergy Immunology & Respiratory Medicine
Melbourne, Victoria, Australia, 3181
Sponsors and Collaborators
Bayside Health
Investigators
Principal Investigator: Robyn O'Hehir, MD FRACP FRCP PhD Alfred Hospital; Monash University
Study Chair: Jennifer Rolland, PhD Alfred Hospital; Monash University
Study Chair: Jo Douglass, MBBS FRACP MD Alfred Hospital; Monash University
  More Information

Publications:
Study ID Numbers: Project 170/05
Study First Received: November 6, 2005
Last Updated: November 6, 2005
ClinicalTrials.gov Identifier: NCT00250263  
Health Authority: Australia: Bayside Health;   Australia: Therapeutic Goods Administration (Clinical Trial Notification Scheme)

Keywords provided by Bayside Health:
rhinitis
asthma
atopy
house dust mite
immunotherapy
SLIT

Study placed in the following topic categories:
Lung Diseases, Obstructive
Hypersensitivity
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Asthma
Rhinitis
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Immune System Diseases
Bronchial Diseases
Nose Diseases

ClinicalTrials.gov processed this record on January 16, 2009