Imperial College London


Protocol for randomised, double blind, placebo-controlled study of grass allergen immunotherapy tablet for seasonal allergic rhinitis


Principal Investigator(s): Professor Stephen Durham
Type of Study: Randomised, double-blind, placebo-controlled study ,trial is registered with ClinicalTrials.gov with trial number NCT02005627
Recruiting? no

Funding Body: Imperial College London
Start Date:
Projected End Date: 30-Apr-2017

Publications:






Summary


Allergen specific immunotherapy is a therapeutic alternative for those whose symptoms are not controlled by standard medical treatment. This is a randomized, double-blind, single-centre, placebo controlled, two arm time course study based in the United Kingdom comparing sublingual allergy immunotherapy tablet (GRAZAX®, ALK-Abello Horsholm,Denmark) plus standard treatment with placebo plus standard treatment.Up to 50 moderate to severe grass pollen allergic participants and 20 non-atopic volunteers are randomized to one of the two treatment arms in a 1:1 ratio. The primary endpoint will be the total nasal symptom score assessed over 60 min following grass pollen nasal allergen challenge after 12 months of treatment when unblinding will take place. Those atopic participants receiving active treatment will continue therapy for another 12 months and the 20 healthy, non-atopic controls will undergo screening and one visit only coinciding with the 12 month visit for the atopic participants.

Lay Summary


Seasonal Allergic Rhinitis is characterised by inflammation of the nasal mucosa upon exposure to common aeroallergens, affecting up to 20–25 % of the population. For those patients whose symptoms are not controlled by standard medical treatment, allergen specific immunotherapy is a therapeutic alternative. Although several studies have shown changes in immunologic responses as well as long term tolerance following treatment with a sublingual allergy immunotherapy tablet, a detailed time course of the early mechanistic changes of local and systemic T and B cell responses and the effects on B cell repertoire in the nasal mucosa have not been fully examined. This is a randomized, double-blind, single-centre, placebo controlled, two arm time course study based in the United Kingdom comparing sublingual allergy immunotherapy tablet (GRAZAX®, ALK-Abello Horsholm,Denmark) plus standard treatment with placebo plus standard treatment.

Summary of Findings


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