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Sponsored by: |
Bayside Health |
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Information provided by: | Bayside Health |
ClinicalTrials.gov Identifier: | NCT00250263 |
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 |
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. |
Estimated Enrollment: | 30 |
Study Start Date: | November 2005 |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Australia, Victoria | |
The Alfred Hospital. Department of Allergy Immunology & Respiratory Medicine | |
Melbourne, Victoria, Australia, 3181 |
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 |
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) |
rhinitis asthma atopy |
house dust mite immunotherapy SLIT |
Lung Diseases, Obstructive Hypersensitivity Otorhinolaryngologic Diseases Respiratory Tract Infections Respiratory Tract Diseases |
Lung Diseases Hypersensitivity, Immediate Asthma Rhinitis Respiratory Hypersensitivity |
Immune System Diseases Bronchial Diseases Nose Diseases |