- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02014623
Immunological Mechanisms of Oralair® in Patients With Seasonal Allergic Rhinitis
October 12, 2020 updated by: Bayside Health
Immunological Mechanisms of Oralair® (5 Grass Mix Sublingual Allergen Immunotherapy Tablet) in Patients With Seasonal Allergic Rhinitis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
51
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
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Victoria
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Melbourne, Victoria, Australia, 3181
- Department of Allergy, Immunology and Respiratory Medicine, The Alfred Hospital- Bayside Health
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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
16 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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 β-blockers
- Immunodeficiency diseases
- Malignancy
- Significant inflammatory condition or disease in the oral cavity
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: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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Other: Control
Standard medical therapy: oral antihistamines AND/OR nasal steroids AND/OR nasal antihistamines
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from Baseline in Ryegrass specific-IgG4 at 4 months and 12 months
Time Frame: Baseline, 4 months, 12 months
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Baseline, 4 months, 12 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Quality of Life assessed by an Allergic Rhinitis Quality of Life Questionnaire at 4, 8 and 12 months
Time Frame: Baseline, 4 months, 8 months, 12 months
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Baseline, 4 months, 8 months, 12 months
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Change in Combined Symptoms and Medication requirements score at 4, 8 and 12 months
Time Frame: Baseline, 4 months, 8 months, 12 months
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Baseline, 4 months, 8 months, 12 months
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Change in Fractional Exhaled Nitric Oxide at 4, 8, and 12 months
Time Frame: Baseline, 4 months, 8 months, 12 months
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Baseline, 4 months, 8 months, 12 months
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Change in Helper and regulatory T cell response to ryegrass pollen at 4 months and 12 months
Time Frame: Baseline,4 months, 12 months
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Baseline,4 months, 12 months
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Change in Ryegrass-specific IgE at 4 months and 12 months
Time Frame: Baseline, 4 months, 12 months
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Baseline, 4 months, 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robyn O'Hehir, MBBS MBBS FRACP FRCP PhD, Director, Department of Allergy, Immunology and Respiratory Medicine, The Alfred Hospital
- Study Director: Mark Hew, MBBS FRACP PhD, Head of Allergy, Asthma and Clinical Immunology Service, Department of Allergy, Immunology and Respiratory Medicine, The Alfred Hospital
- Study Chair: Jennifer Rolland, BSc, PhD, Emeritus Professor Central Clinical School Monash University
- Study Chair: Alessandra Sandrini, MD, PhD, Senior Clinical Fellow, Department of Allergy, Immunology and Respiratory Medicine, The Alfred Hospital
- Study Chair: Celia Zubrinich, MBBS FRACP, Consultant, Department of Allergy, Immunology and Respiratory Medicine, The Alfred Hospital
- Study Chair: Nirupama Varese, BSc Hons, MSc, Research Officer, Central Clinical School 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.
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 (Actual)
February 1, 2014
Primary Completion (Actual)
November 15, 2019
Study Registration Dates
First Submitted
November 19, 2013
First Submitted That Met QC Criteria
December 12, 2013
First Posted (Estimate)
December 18, 2013
Study Record Updates
Last Update Posted (Actual)
October 14, 2020
Last Update Submitted That Met QC Criteria
October 12, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Otorhinolaryngologic Diseases
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Rhinitis
- Rhinitis, Allergic
- Rhinitis, Allergic, Seasonal
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Histamine Agents
- Histamine Antagonists
Other Study ID Numbers
- 514/13
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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