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Allergic RhinitisPhase 4NCT00250263

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

A Phase 4 study testing (agent for immunotherapy) Staloral in people with Allergic Rhinitis and Asthma, run by Bayside Health at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Allergic Rhinitis, Asthma
What is being tested?
(agent for immunotherapy) Staloral
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteAustralia
Study dates
Nov 2005to Dec 2008
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • The Alfred Hospital. Department of Allergy Immunology & Respiratory Medicine

    Melbourne, Victoria, 3181

Other trials in Australia

About this study

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.

Being tested
(agent for immunotherapy) Staloral, Placebo
Keywords
rhinitis, asthma, atopy, house dust mite, immunotherapy, SLIT
Medical subject headings
Rhinitis, Allergic, Asthma, Rhinitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • (agent for immunotherapy) StaloralDrug

    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

  • PlaceboDrug

    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

Study groups in NCT00250263
Study groupRoleWhat they receive
1Placebo comparatorMatching placebo- control arm (first year)
Receives: Drug: Placebo
2Active comparatorDrug Staloral (active group)
Receives: Drug: (agent for immunotherapy) Staloral

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 and 24 months

  2. -Expression of "immunoregulatory" cytokines by CD4+ T

    Measured: 12 and 24 months

  3. cells

    Measured: 12 and 24 months

  4. - Helper, regulatory and memory T cell subsets

    Measured: 12 and 24 months

  5. (a) Helper T cells

    Measured: 12 and 24 months

  6. (b) Regulatory T cells

    Measured: 12 and 24 months

  7. b1- Regulatory T cell phenotype

    Measured: 12 and 24 months

  8. b2- Regulatory T cell function

    Measured: 12 and 24 months

Secondary outcomes (1)

  1. Symptom diary, medication use, visual analogue score, disease-specific rhinoconjunctivitis Quality of Life Questionnaire

    Measured: 12 and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2005 (estimated)
  2. Study startNov 2005
  3. Primary completionDec 2008
  4. Study completionDec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00250263
Sponsor's protocol ID
Project 170/05
Status last verified
Nov 2005
First submitted
6 Nov 2005
Last updated
13 Feb 2013
Results posted
No

Publications

  • Fanta C, Bohle B, Hirt W, Siemann U, Horak F, Kraft D, Ebner H, Ebner C. Systemic immunological changes induced by administration of grass pollen allergens via the oral mucosa during sublingual immunotherapy. Int Arch Allergy Immunol. 1999 Nov;120(3):218-24. doi: 10.1159/000024270.

    PubMed 10592467

  • Gardner LM, Thien FC, Douglass JA, Rolland JM, O'Hehir RE. Induction of T 'regulatory' cells by standardized house dust mite immunotherapy: an increase in CD4+ CD25+ interleukin-10+ T cells expressing peripheral tissue trafficking markers. Clin Exp Allergy. 2004 Aug;34(8):1209-19. doi: 10.1111/j.1365-2222.2004.02009.x.

    PubMed 15298560

  • Rolland JM, Douglass J, O'Hehir RE. Allergen immunotherapy: current and new therapeutic strategies. Expert Opin Investig Drugs. 2000 Mar;9(3):515-27. doi: 10.1517/13543784.9.3.515.

    PubMed 11060692

  • O'Hehir RE, Gardner LM, de Leon MP, Hales BJ, Biondo M, Douglass JA, Rolland JM, Sandrini A. House dust mite sublingual immunotherapy: the role for transforming growth factor-beta and functional regulatory T cells. Am J Respir Crit Care Med. 2009 Nov 15;180(10):936-47. doi: 10.1164/rccm.200905-0686OC. Epub 2009 Aug 20.

    PubMed 19696440

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing (agent for immunotherapy) Staloral in people with Allergic Rhinitis and Asthma, run by Bayside Health at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00250263, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2013.

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