NCT02014623

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

Completed Phase 4 Last updated 12 October 2020

What this trial tests

Phase 4 trial testing Grass pollen sublingual immunotherapy tablet in Allergic Rhinitis in 51 participants. Completed.

Timeline

1 February 2014

Primary endpoint
15 November 2019

Quick facts

Lead sponsor	Bayside Health
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	51
Start date	1 February 2014
Primary completion	15 November 2019
Sites	1 location across Australia

Drugs / interventions tested

• Grass pollen sublingual immunotherapy tablet
• Control

Conditions studied

• Allergic Rhinitis — all drugs for Allergic Rhinitis →

Sponsor

Bayside Health — full company profile →

Who can join

Adults 16 to 65, any sex, with Allergic Rhinitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change from Baseline in Ryegrass specific-IgG4 at 4 months and 12 months
  Time frame: Baseline, 4 months, 12 months

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Induction of IgG₂ and IgG₄ B-cell memory following sublingual immunotherapy for ryegrass pollen allergy.
   Heeringa JJ, McKenzie CI, Varese N, Hew M, et al · · 2020 · cited 70× · PMID 31587307 · DOI 10.1111/all.14073
2. Sublingual immunotherapy for asthma.
   Normansell R, Kew KM, Bridgman AL. · · 2015 · cited 40× · PMID 26315994 · DOI 10.1002/14651858.cd011293.pub2
3. Sublingual immunotherapy for asthma.
   Fortescue R, Kew KM, Leung MST. · · 2020 · cited 23× · PMID 32926419 · DOI 10.1002/14651858.cd011293.pub3