Immunological Mechanisms of Oralair® in Patients With Seasonal Allergic Rhinitis

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Bayside Health
Sponsor:
Information provided by (Responsible Party):
Bayside Health
ClinicalTrials.gov Identifier:
NCT02014623
First received: November 19, 2013
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Allergic Rhinitis
Other: Grass pollen sublingual immunotherapy tablet
Drug: Control
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Immunological Mechanisms of Oralair® (5 Grass Mix Sublingual Allergen Immunotherapy Tablet) in Patients With Seasonal Allergic Rhinitis

Resource links provided by NLM:


Further study details as provided by Bayside Health:

Primary Outcome Measures:
  • Change from Baseline in Ryegrass specific-IgG4 at 4 months and 12 months [ Time Frame: Baseline, 4 months, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Change in Combined Symptoms and Medication requirements score at 4, 8 and 12 months [ Time Frame: Baseline, 4 months, 8 months, 12 months ] [ Designated as safety issue: No ]
  • Change in Fractional Exhaled Nitric Oxide at 4, 8, and 12 months [ Time Frame: Baseline, 4 months, 8 months, 12 months ] [ Designated as safety issue: No ]
  • Change in Helper and regulatory T cell response to ryegrass pollen at 4 months and 12 months [ Time Frame: Baseline,4 months, 12 months ] [ Designated as safety issue: No ]
  • Change in Ryegrass-specific IgE at 4 months and 12 months [ Time Frame: Baseline, 4 months, 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: February 2014
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Grass pollen sublingual immunotherapy tablet
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
Standard medical therapy: oral antihistamines AND/OR nasal steroids AND/OR nasal antihistamines
Drug: Control
Other Name: Oral anthistamines AND/OR Nasal steroids AND/OR Nasal antihistamines

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02014623

Contacts
Contact: Robyn O'Hehir, MBBS FRACP FRCP PhD +61 3 90762251 r.ohehir@alfred.org.au

Locations
Australia, Victoria
Department of Allergy, Immunology and Respiratory Medicine, The Alfred Hospital- Bayside Health Not yet recruiting
Melbourne, Victoria, Australia, 3181
Contact: Professor Robyn O'Hehir, BSc MBBS FRACP FRCP PhD    +61 3 90762251    r.ohehir@alfred.org.au   
Principal Investigator: Robyn O'Hehir, MBBs FRACP FRCP PhD         
Sub-Investigator: Mark Hew, MBBS FRACP PhD         
Sub-Investigator: Jennifer Rolland, BSc PhD         
Sub-Investigator: Alessandra Sandrini, MD PhD         
Sub-Investigator: Celia Zubrinich, MBBS FRACP         
Sub-Investigator: Nirupama Varese, BSc Hons, MSc         
Sponsors and Collaborators
Bayside Health
Investigators
Principal Investigator: Robyn O'Hehir, MBBS MBBS FRACP FRCP PhD Director, Department of Allergy, Immunology and Respiratory Medicine, The Alfred Hospital
Study Director: Mark Hew, MBBS FRACP PhD Head of Allergy, Asthma and Clinical Immunology Service, Department of Allergy, Immunology and Respiratory Medicine, The Alfred Hospital
Study Chair: 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
  More Information

No publications provided

Responsible Party: Bayside Health
ClinicalTrials.gov Identifier: NCT02014623     History of Changes
Other Study ID Numbers: 514/13
Study First Received: November 19, 2013
Last Updated: January 16, 2014
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Bayside Health:
Allergic rhinitis
Asthma
Regulatory T cells
IgE
IgG4

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Histamine Antagonists
Histamine H1 Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014