The Alfred Hospital. Department of Allergy Immunology & Respiratory Medicine
Melbourne, Victoria, 3181, Australia
NCT Number: 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. The first year will be followed by an optional open label extension period. 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.
Looking for future studies?
Notify Me18 year–70 year
All sexes
Interventional
Phase 4
Melbourne, Victoria, 3181, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Immunotherapy agent for sublingual daily use. First week (vial containing the concentration 10 IR/ml) Day 1 - 1 pressure Day 2 - 2 pressures Day 3 - 4 pressures Day 4 - 6 pressures Day 5 - 8 pressures Day 6 - 10 pressures
Second week (300 IR/ml) (vial containing the concentration 300 IR/ml) Day 7 - 1 pressure Day 8 - 2 pressures Day 9 - 4 pressures Day 10 - 6 pressures Day 11 - 8 pressures
Maintenance phase Day 12 to 364 - 8 pressures daily
The first year will be followed by a second year open label period (optional)- 8 pressures daily
Matching placebo for sublingual use. Same schedule used for the intervention ACTIVE group.
First week (vial containing placebo) Day 1 - 1 pressure Day 2 - 2 pressures Day 3 - 4 pressures Day 4 - 6 pressures Day 5 - 8 pressures Day 6 - 10 pressures
Second week (300 IR/ml) (vial containing placebo) Day 7 - 1 pressure Day 8 - 2 pressures Day 9 - 4 pressures Day 10 - 6 pressures Day 11 - 8 pressures
Maintenance phase Day 12 to 364 - 8 pressures daily
Time frame: 12 and 24 months
Time frame: 12 and 24 months
Time frame: 12 and 24 months
Time frame: 12 and 24 months
Time frame: 12 and 24 months
Time frame: 12 and 24 months
Time frame: 12 and 24 months
Time frame: 12 and 24 months
Time frame: 12 and 24 months
Bayside Health
Other Gov
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