Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00250263




Registration number
NCT00250263
Ethics application status
Date submitted
6/11/2005
Date registered
8/11/2005
Date last updated
13/02/2013

Titles & IDs
Public title
A Trial of Immunological Outcomes of Sublingual Immunotherapy for House Dust Mite (D. Pteronyssinus) Allergy
Scientific title
A Trial of Immunological Outcomes of Sublingual Immunotherapy for House Dust Mite (D. Pteronyssinus) Allergy
Secondary ID [1] 0 0
Project 170/05
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergic Rhinitis 0 0
Asthma 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Allergies
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - (agent for immunotherapy) Staloral
Treatment: Drugs - Placebo

Placebo comparator: 1 - Matching placebo- control arm (first year)

Active comparator: 2 - Drug Staloral (active group)


Treatment: Drugs: (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

Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
12 and 24 months
Primary outcome [2] 0 0
-Expression of "immunoregulatory" cytokines by CD4+ T
Timepoint [2] 0 0
12 and 24 months
Primary outcome [3] 0 0
cells
Timepoint [3] 0 0
12 and 24 months
Primary outcome [4] 0 0
- Helper, regulatory and memory T cell subsets
Timepoint [4] 0 0
12 and 24 months
Primary outcome [5] 0 0
(a) Helper T cells
Timepoint [5] 0 0
12 and 24 months
Primary outcome [6] 0 0
(b) Regulatory T cells
Timepoint [6] 0 0
12 and 24 months
Primary outcome [7] 0 0
b1- Regulatory T cell phenotype
Timepoint [7] 0 0
12 and 24 months
Primary outcome [8] 0 0
b2- Regulatory T cell function
Timepoint [8] 0 0
12 and 24 months
Secondary outcome [1] 0 0
Symptom diary, medication use, visual analogue score, disease-specific rhinoconjunctivitis Quality of Life Questionnaire
Timepoint [1] 0 0
12 and 24 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2008
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital. Department of Allergy Immunology & Respiratory Medicine - Melbourne
Recruitment postcode(s) [1] 0 0
3181 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Bayside Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robyn O'Hehir, MD FRACP FRCP PhD
Address 0 0
Alfred Hospital; Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00250263