Immunological Mechanisms of Oralair® in Patients With Seasonal Allergic Rhinitis

Bayside Health

Status and phase: Completed; Phase 4

Conditions: Allergic Rhinitis

Treatments: Other: Grass pollen sublingual immunotherapy tablet; Drug: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT02014623

514/13

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

Grass pollen sublingual immunotherapy tablet

Active Comparator group

Description:

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.

Treatment:

Other: Grass pollen sublingual immunotherapy tablet

Control

Other group

Description:

Standard medical therapy: oral antihistamines AND/OR nasal steroids AND/OR nasal antihistamines

Treatment:

Drug: Control