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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00250263
First Posted: November 8, 2005
Last Update Posted: February 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayside Health
  Purpose
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.

Condition Intervention Phase
Allergic Rhinitis Asthma Drug: (agent for immunotherapy) Staloral Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Trial of Immunological Outcomes of Sublingual Immunotherapy for House Dust Mite (D. Pteronyssinus) Allergy

Resource links provided by NLM:


Further study details as provided by Bayside Health:

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

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

Enrollment: 30
Study Start Date: November 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00250263


Locations
Australia, Victoria
The Alfred Hospital. Department of Allergy Immunology & Respiratory Medicine
Melbourne, Victoria, Australia, 3181
Sponsors and Collaborators
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
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayside Health
ClinicalTrials.gov Identifier: NCT00250263     History of Changes
Other Study ID Numbers: Project 170/05
First Submitted: November 6, 2005
First Posted: November 8, 2005
Last Update Posted: February 13, 2013
Last Verified: November 2005

Keywords provided by Bayside Health:
rhinitis
asthma
atopy
house dust mite
immunotherapy
SLIT

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases