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

February 11, 2013 updated by: Bayside Health
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Matching placebo- control arm (first year)
Drug: Placebo

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
Active Comparator: 2
Drug Staloral (active group)
Drug: (agent for immunotherapy) Staloral

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Symptom diary, medication use, visual analogue score, disease-specific rhinoconjunctivitis Quality of Life Questionnaire
Time Frame: 12 and 24 months
12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

November 6, 2005

First Submitted That Met QC Criteria

November 6, 2005

First Posted (Estimate)

November 8, 2005

Study Record Updates

Last Update Posted (Estimate)

February 13, 2013

Last Update Submitted That Met QC Criteria

February 11, 2013

Last Verified

November 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Project 170/05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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