Clinical trial NCT02014623: Immunological Mechanisms of Oralair® in Patients With Seasonal Allergic Rhinitis
Official title: Immunological Mechanisms of Oralair® (5 Grass Mix Sublingual Allergen Immunotherapy Tablet) in Patients With Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Rhinitis
Keywords: Allergic rhinitis
Asthma
Regulatory T cells
IgE
IgG4
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
First posted: 2013-12-18
Enrollment: 51
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in Ryegrass specific-IgG4 at 4 months and 12 months
timeFrame: Baseline, 4 months, 12 months
Secondary outcomes:
measure: Change in Quality of Life assessed by an Allergic Rhinitis Quality of Life Questionnaire at 4, 8 and 12 months
timeFrame: Baseline, 4 months, 8 months, 12 months
measure: Change in Combined Symptoms and Medication requirements score at 4, 8 and 12 months
timeFrame: Baseline, 4 months, 8 months, 12 months
measure: Change in Fractional Exhaled Nitric Oxide at 4, 8, and 12 months
timeFrame: Baseline, 4 months, 8 months, 12 months
measure: Change in Helper and regulatory T cell response to ryegrass pollen at 4 months and 12 months
timeFrame: Baseline,4 months, 12 months
measure: Change in Ryegrass-specific IgE at 4 months and 12 months
timeFrame: Baseline, 4 months, 12 months
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Department of Allergy, Immunology and Respiratory Medicine, The Alfred Hospital- Bayside Health
state: Victoria
Study officials:
affiliation: Director, Department of Allergy, Immunology and Respiratory Medicine, The Alfred Hospital
name: Robyn O'Hehir, MBBS MBBS FRACP FRCP PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Head of Allergy, Asthma and Clinical Immunology Service, Department of Allergy, Immunology and Respiratory Medicine, The Alfred Hospital
name: Mark Hew, MBBS FRACP PhD
role: STUDY_DIRECTOR
affiliation: Emeritus Professor Central Clinical School Monash University
name: Jennifer Rolland, BSc, PhD
role: STUDY_CHAIR
affiliation: Senior Clinical Fellow, Department of Allergy, Immunology and Respiratory Medicine, The Alfred Hospital
name: Alessandra Sandrini, MD, PhD
role: STUDY_CHAIR
affiliation: Consultant, Department of Allergy, Immunology and Respiratory Medicine, The Alfred Hospital
name: Celia Zubrinich, MBBS FRACP
role: STUDY_CHAIR
affiliation: Research Officer, Central Clinical School Monash University
name: Nirupama Varese, BSc Hons, MSc
role: STUDY_CHAIR
References:
citation: 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.