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

Further study details as provided by Bayside Health:

Primary Outcomes: 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 Outcomes: Symptom diary, medication use, visual analogue score, disease-specific rhinoconjunctivitis Quality of Life Questionnaire
Expected Total Enrollment:  30

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00250263

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

Australia, Victoria
      The Alfred Hospital. Department of Allergy Immunology & Respiratory Medicine, Melbourne,  Victoria,  3181,  Australia

Study chairs or principal investigators

Robyn O''''Hehir, MD FRACP FRCP PhD,  Principal Investigator,  Alfred Hospital; Monash University   
Jennifer Rolland, PhD,  Study Chair,  Alfred Hospital; Monash University   
Jo Douglass, MBBS FRACP MD,  Study Chair,  Alfred Hospital; Monash University   

Study ID Numbers:  Project 170/05
Last Updated:  December 8, 2005
Record first received:  November 6, 2005
ClinicalTrials.gov Identifier:  NCT00250263
Health Authority: Australia: Bayside Health; Australia: Therapeutic Goods Administration (Clinical Trial Notification Scheme)
ClinicalTrials.gov processed this record on 2006-01-10