Allergic RhinitisPhase 4NCT02014623
Immunological Mechanisms of Oralair® in Patients With Seasonal Allergic Rhinitis
A Phase 4 study testing Grass pollen sublingual immunotherapy tablet in people with Allergic Rhinitis, run by Bayside Health at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Grass pollen sublingual immunotherapy tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteAustralia
- Study dates
- Feb 2014to 15 Nov 2019
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects of Chinese heritage or non-Chinese heritage
- Clinical diagnosis of moderate to severe seasonal allergic rhinitis
- Ryegrass-specific IgE : CAP-Pharmacia score > 1
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Department of Allergy, Immunology and Respiratory Medicine, The Alfred Hospital- Bayside Health
Melbourne, Victoria, 3181
About this study
Official title: 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.
- Conditions
- Allergic Rhinitis
- Being tested
- Grass pollen sublingual immunotherapy tablet, Control
- Keywords
- Allergic rhinitis, Asthma, Regulatory T cells, IgE, IgG4
- Medical subject headings
- Rhinitis, Allergic, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grass pollen sublingual immunotherapy tabletOther
ControlDrug
Also called Oral anthistamines AND/OR Nasal steroids AND/OR Nasal antihistamines
| Study group | Role | What they receive |
|---|---|---|
| Grass pollen sublingual immunotherapy tablet | Active comparator | 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. Receives: Other: Grass pollen sublingual immunotherapy tablet |
| Control | Other | Standard medical therapy: oral antihistamines AND/OR nasal steroids AND/OR nasal antihistamines Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Ryegrass specific-IgG4 at 4 months and 12 months
Measured: Baseline, 4 months, 12 months
Secondary outcomes (5)
Change in Quality of Life assessed by an Allergic Rhinitis Quality of Life Questionnaire at 4, 8 and 12 months
Measured: Baseline, 4 months, 8 months, 12 months
Change in Combined Symptoms and Medication requirements score at 4, 8 and 12 months
Measured: Baseline, 4 months, 8 months, 12 months
Change in Fractional Exhaled Nitric Oxide at 4, 8, and 12 months
Measured: Baseline, 4 months, 8 months, 12 months
Change in Helper and regulatory T cell response to ryegrass pollen at 4 months and 12 months
Measured: Baseline,4 months, 12 months
Change in Ryegrass-specific IgE at 4 months and 12 months
Measured: Baseline, 4 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2013 (estimated)
- Study startFeb 2014
- Primary completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Robyn O'Hehir, MBBS MBBS FRACP FRCP PhD, Principal investigator, Director, Department of Allergy, Immunology and Respiratory Medicine, The Alfred HospitalMark Hew, MBBS FRACP PhD, Study director, Head of Allergy, Asthma and Clinical Immunology Service, Department of Allergy, Immunology and Respiratory Medicine, The Alfred HospitalJennifer Rolland, BSc, PhD, Study chair, Emeritus Professor Central Clinical School Monash UniversityAlessandra Sandrini, MD, PhD, Study chair, Senior Clinical Fellow, Department of Allergy, Immunology and Respiratory Medicine, The Alfred HospitalCelia Zubrinich, MBBS FRACP, Study chair, Consultant, Department of Allergy, Immunology and Respiratory Medicine, The Alfred HospitalNirupama Varese, BSc Hons, MSc, Study chair, Research Officer, Central Clinical School Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02014623
- Sponsor's protocol ID
- 514/13
- Status last verified
- Oct 2020
- First submitted
- 19 Nov 2013
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
O'Hehir RE, Varese NP, Deckert K, Zubrinich CM, van Zelm MC, Rolland JM, Hew M. Epidemic Thunderstorm Asthma Protection with Five-Grass Pollen Tablet Sublingual Immunotherapy: A Clinical Trial. Am J Respir Crit Care Med. 2018 Jul 1;198(1):126-128. doi: 10.1164/rccm.201711-2337LE. No abstract available.
PubMed 29461859
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological Mechanisms of Oralair® (5 Grass Mix Sublingual Allergen Immunotherapy Tablet) in Patients With Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT02014623
- Acronym / sponsor ID
- 514/13
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic rhinitis, Asthma, Regulatory T cells, IgE, IgG4
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Bayside HealthOther government
- Study start
- Feb 2014 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- First posted
- 18 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grass pollen sublingual immunotherapy tablet | Active comparator | Other: Grass pollen sublingual immunotherapy tabletA 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. |
| Control | Other | Drug: ControlStandard medical therapy: oral antihistamines AND/OR nasal steroids AND/OR nasal antihistamines |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects of Chinese heritage or non-Chinese heritage
- Clinical diagnosis of moderate to severe seasonal allergic rhinitis
- Ryegrass-specific IgE : CAP-Pharmacia score > 1
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grass pollen sublingual immunotherapy tablet | Other | Grass pollen sublingual immunotherapy tablet |
| ControlAlso: Oral anthistamines AND/OR Nasal steroids AND/OR Nasal antihistamines | Drug | Control |
Primary outcome
Change from Baseline in Ryegrass specific-IgG4 at 4 months and 12 months
Time frame: Baseline, 4 months, 12 months
5 secondary outcomes
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
Change in Combined Symptoms and Medication requirements score at 4, 8 and 12 months
Time frame: Baseline, 4 months, 8 months, 12 months
Change in Fractional Exhaled Nitric Oxide at 4, 8, and 12 months
Time frame: Baseline, 4 months, 8 months, 12 months
Change in Helper and regulatory T cell response to ryegrass pollen at 4 months and 12 months
Time frame: Baseline,4 months, 12 months
Change in Ryegrass-specific IgE at 4 months and 12 months
Time frame: Baseline, 4 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Derived from this study: PubMed 29461859O'Hehir RE, Varese NP, Deckert K, Zubrinich CM, van Zelm MC, Rolland JM, Hew M. Epidemic Thunderstorm Asthma Protection with Five-Grass Pollen Tablet Sublingual Immunotherapy: A Clinical Trial. Am J Respir Crit Care Med. 2018 Jul 1;198(1):126-128. doi: 10.1164/rccm.201711-2337LE. No abstract available.
Related trials for Allergic Rhinitis
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RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
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RecruitingPhase 3
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robyn O'Hehir, MBBS MBBS FRACP FRCP PhD principal investigator
Director, Department of Allergy, Immunology and Respiratory Medicine, The Alfred Hospital
Mark Hew, MBBS FRACP PhD study director
Head of Allergy, Asthma and Clinical Immunology Service, Department of Allergy, Immunology and Respiratory Medicine, The Alfred Hospital
Jennifer Rolland, BSc, PhD study chair
Emeritus Professor Central Clinical School Monash University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Grass pollen sublingual immunotherapy tablet in people with Allergic Rhinitis, 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 3 inclusion and 8 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 14 Oct 2020. 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. 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?
Change from Baseline in Ryegrass specific-IgG4 at 4 months and 12 months (time frame: Baseline, 4 months, 12 months). 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 NCT02014623, which also lists 1 linked publication.
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 14 Oct 2020.