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OpenTrials
Completed

NCT Number: NCT02014623

Immunological Mechanisms of Oralair® 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.

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Key information

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Allergy, Immunology and Respiratory Medicine, The Alfred Hospital- Bayside Health

Melbourne, Victoria, 3181, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Grass pollen sublingual immunotherapy tablet

Other

Control

Drug

Other names: Oral anthistamines AND/OR Nasal steroids AND/OR Nasal antihistamines

Primary outcomes

  1. Change from Baseline in Ryegrass specific-IgG4 at 4 months and 12 months

    Time frame: Baseline, 4 months, 12 months

Secondary outcomes

  1. 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

  2. Change in Combined Symptoms and Medication requirements score at 4, 8 and 12 months

    Time frame: Baseline, 4 months, 8 months, 12 months

  3. Change in Fractional Exhaled Nitric Oxide at 4, 8, and 12 months

    Time frame: Baseline, 4 months, 8 months, 12 months

  4. Change in Helper and regulatory T cell response to ryegrass pollen at 4 months and 12 months

    Time frame: Baseline,4 months, 12 months

  5. Change in Ryegrass-specific IgE at 4 months and 12 months

    Time frame: Baseline, 4 months, 12 months

Sponsors and collaborators

Lead sponsor

Bayside Health

Other Gov

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
First posted
Dec 18, 2013
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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