Immunological Mechanisms of Oralair® in Patients With Seasonal Allergic Rhinitis

NCT02014623 | Completed Phase 4

• 1 other identifier: 514/13
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis

Keywords

Allergic rhinitis; Asthma; Regulatory T cells; IgE; IgG4

Outcome Measures

Primary Outcomes (1)

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

  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

  Baseline, 4 months, 8 months, 12 months

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

  Baseline, 4 months, 8 months, 12 months

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

  Baseline, 4 months, 8 months, 12 months

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

  Baseline,4 months, 12 months

• Change in Ryegrass-specific IgE at 4 months and 12 months

  Baseline, 4 months, 12 months

Study Arms (2)

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.

Other: Grass pollen sublingual immunotherapy tablet

Control

OTHER

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

Drug: Control

Interventions

Grass pollen sublingual immunotherapy tablet OTHER

Grass pollen sublingual immunotherapy tablet

Control DRUG

Also known as: Oral anthistamines AND/OR Nasal steroids AND/OR Nasal antihistamines

Control

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects of Chinese heritage or non-Chinese heritage
• Clinical diagnosis of moderate to severe seasonal allergic rhinitis
• Ryegrass-specific IgE : CAP-Pharmacia score \> 1

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayside Health: lead

Study Sites (1)

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

Melbourne, Victoria, 3181, Australia

Location

Related Publications (1)

• 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.

  PMID: 29461859 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic; Asthma

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Robyn O'Hehir, MBBS MBBS FRACP FRCP PhD

  Director, Department of Allergy, Immunology and Respiratory Medicine, The Alfred Hospital

  PRINCIPAL INVESTIGATOR

• Mark Hew, MBBS FRACP PhD

  Head of Allergy, Asthma and Clinical Immunology Service, Department of Allergy, Immunology and Respiratory Medicine, The Alfred Hospital

  STUDY DIRECTOR

• Jennifer Rolland, BSc, PhD

  Emeritus Professor Central Clinical School Monash University

  STUDY CHAIR

• Alessandra Sandrini, MD, PhD

  Senior Clinical Fellow, Department of Allergy, Immunology and Respiratory Medicine, The Alfred Hospital

  STUDY CHAIR

• Celia Zubrinich, MBBS FRACP

  Consultant, Department of Allergy, Immunology and Respiratory Medicine, The Alfred Hospital

  STUDY CHAIR

• Nirupama Varese, BSc Hons, MSc

  Research Officer, Central Clinical School Monash University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2013
• First Posted: December 18, 2013
• Study Start: February 1, 2014
• Primary Completion: November 15, 2019
• Last Updated: October 14, 2020

Record last verified: 2020-10

Locations

AU (1)