Immunological Mechanisms of Oralair® in Patients With Seasonal Allergic Rhinitis

Allergic Rhinitis Clinical Trial

Official title:

Immunological Mechanisms of Oralair® (5 Grass Mix Sublingual Allergen Immunotherapy Tablet) in Patients With Seasonal Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02014623
• Other study ID #: 514/13
• Status: Completed
• Phase: Phase 4
• Start date: February 2014

Study information

• Verified date: October 2020
• Source: Bayside Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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 ß-blockers

• Immunodeficiency diseases

• Malignancy

• Significant inflammatory condition or disease in the oral cavity

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal

Intervention

Other:
• Grass pollen sublingual immunotherapy tablet

Drug:
• Control

Locations

Country	Name	City	State
Australia	Department of Allergy, Immunology and Respiratory Medicine, The Alfred Hospital- Bayside Health	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Bayside Health

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Ryegrass specific-IgG4 at 4 months and 12 months		Baseline, 4 months, 12 months
Secondary	Change in Quality of Life assessed by an Allergic Rhinitis Quality of Life Questionnaire at 4, 8 and 12 months		Baseline, 4 months, 8 months, 12 months
Secondary	Change in Combined Symptoms and Medication requirements score at 4, 8 and 12 months		Baseline, 4 months, 8 months, 12 months
Secondary	Change in Fractional Exhaled Nitric Oxide at 4, 8, and 12 months		Baseline, 4 months, 8 months, 12 months
Secondary	Change in Helper and regulatory T cell response to ryegrass pollen at 4 months and 12 months		Baseline,4 months, 12 months
Secondary	Change in Ryegrass-specific IgE at 4 months and 12 months		Baseline, 4 months, 12 months