A Trial of Immunological Outcomes of Sublingual Immunotherapy for House Dust Mite (D. Pteronyssinus) Allergy

Phase 4

Completed

• Conditions: Allergic Rhinitis; Asthma
• Interventions: Drug: Placebo; Drug: (agent for immunotherapy) Staloral

• Registration Number: NCT00250263
• Lead Sponsor: Bayside Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2005-11
• Study Start: 2005-11
• Study First Submitted: 2005-11-06
• Study First Submitted QC: 2005-11-06
• Study First Posted: 2005-11-08
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Last Update Submitted: 2013-02-11
• Last Update Posted: 2013-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	Matching placebo- control arm (first year)
2	(agent for immunotherapy) Staloral	Drug Staloral (active group)

Primary Outcome Measures

Name	Time	Method
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.	12 and 24 months
-Expression of "immunoregulatory" cytokines by CD4+ T	12 and 24 months
cells	12 and 24 months
- Helper, regulatory and memory T cell subsets	12 and 24 months
(a) Helper T cells	12 and 24 months
(b) Regulatory T cells	12 and 24 months
b1- Regulatory T cell phenotype	12 and 24 months
b2- Regulatory T cell function	12 and 24 months

Secondary Outcome Measures

Name	Time	Method
Symptom diary, medication use, visual analogue score, disease-specific rhinoconjunctivitis Quality of Life Questionnaire	12 and 24 months

Trial Locations

Locations (1)

The Alfred Hospital. Department of Allergy Immunology & Respiratory Medicine; 🇦🇺 Melbourne, Victoria, Australia