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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02014623




Registration number
NCT02014623
Ethics application status
Date submitted
19/11/2013
Date registered
18/12/2013
Date last updated
14/10/2020

Titles & IDs
Public title
Immunological Mechanisms of Oralair® in Patients With Seasonal Allergic Rhinitis
Scientific title
Immunological Mechanisms of Oralair® (5 Grass Mix Sublingual Allergen Immunotherapy Tablet) in Patients With Seasonal Allergic Rhinitis
Secondary ID [1] 0 0
514/13
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergic Rhinitis 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
Other interventions - Grass pollen sublingual immunotherapy tablet
Treatment: Drugs - Control

Active Comparator: Grass pollen sublingual immunotherapy tablet - A sublingual allergen immunotherapy tablet (Oralair) containing: 300 index of reactivity (IR) of 5 grass pollen allergen extracts:perennial ryegrass (Lolium perenne), meadow grass (Poa pratensis), timothy grass (Phleum pratense), cocksfoot (Dactylis glomerata) and sweet vernal grass (Anthoxanthum odoratum) in an open label fashion administered for 4 months prior to the pollen season.

Other: Control - Standard medical therapy: oral antihistamines AND/OR nasal steroids AND/OR nasal antihistamines


Other interventions: Grass pollen sublingual immunotherapy tablet


Treatment: Drugs: Control
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline in Ryegrass specific-IgG4 at 4 months and 12 months
Timepoint [1] 0 0
Baseline, 4 months, 12 months
Secondary outcome [1] 0 0
Change in Quality of Life assessed by an Allergic Rhinitis Quality of Life Questionnaire at 4, 8 and 12 months
Timepoint [1] 0 0
Baseline, 4 months, 8 months, 12 months
Secondary outcome [2] 0 0
Change in Combined Symptoms and Medication requirements score at 4, 8 and 12 months
Timepoint [2] 0 0
Baseline, 4 months, 8 months, 12 months
Secondary outcome [3] 0 0
Change in Fractional Exhaled Nitric Oxide at 4, 8, and 12 months
Timepoint [3] 0 0
Baseline, 4 months, 8 months, 12 months
Secondary outcome [4] 0 0
Change in Helper and regulatory T cell response to ryegrass pollen at 4 months and 12 months
Timepoint [4] 0 0
Baseline,4 months, 12 months
Secondary outcome [5] 0 0
Change in Ryegrass-specific IgE at 4 months and 12 months
Timepoint [5] 0 0
Baseline, 4 months, 12 months

Eligibility
Key inclusion criteria
- Subjects of Chinese heritage or non-Chinese heritage

- Clinical diagnosis of moderate to severe seasonal allergic rhinitis

- Ryegrass-specific IgE : CAP-Pharmacia score > 1
Minimum age
16 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Ongoing immunotherapy or previous immunotherapy (within last 5 years)

- Continuous oral corticosteroids

- Moderate, severe or unstable asthma

- Standard contraindications for allergen immunotherapy

- Ongoing treatment with ß-blockers

- Immunodeficiency diseases

- Malignancy

- Significant inflammatory condition or disease in the oral cavity

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



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
1/02/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
51
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Department of Allergy, Immunology and Respiratory Medicine, The Alfred Hospital- Bayside Health - Melbourne
Recruitment postcode(s) [1] 0 0
3181 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Allergic diseases represent a major health issue worldwide and epidemiological studies in
Melbourne, Australia, have reported a high prevalence of rhinitis (hayfever) and atopy
(genetic tendency to make allergy antibody) in Asian and Caucasian subjects. Mainstay
treatment of allergic rhinitis 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 the sublingual route (SLIT) and recently sublingual tablets for pollen
allergy immunotherapy became available. The tablets are safe and easy to use and contain
pollen extracts from 5 of the most common allergy-causing European grasses but include
ryegrass (Lolium perenne), the major seasonal pollen for allergy in Melbourne and
south-eastern Australia. The immunological mechanisms of sublingual immunotherapy are not
fully understood. The investigators propose conducting a longitudinal open label study to
investigate the immunological changes that occur with the 5 grass pollen sublingual
immunotherapy tablet (Oralair®) in a cohort of Chinese and non-Chinese background subjects.
The investigators will investigate the induction of relevant T cell regulatory immune
mechanisms and changes in serum allergen-specific immunoglobulin (Ig) E and IgG4.
Immunoregulatory cytokine synthesis and T cell phenotype (Bio-plex and flow cytometry) will
be examined. This project will provide important fundamental knowledge on which to inform
decisions for the greater application of this treatment for subjects with moderate and severe
allergic rhinitis.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02014623
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robyn O'Hehir, MBBS MBBS FRACP FRCP PhD
Address 0 0
Director, Department of Allergy, Immunology and Respiratory Medicine, The Alfred Hospital
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02014623