Grass Pollen Allergen Immunotherapy Tablet (AIT) Time Course Study
Status:
Completed
Trial end date:
2017-03-01
Target enrollment:
Participant gender:
Summary
About 45 million people in Europe have allergic rhinitis (hay fever) - inflammation of the
nasal passages causing sneezing, runny nose, nasal congestion, itching and tearing of the
eyes. In the United Kingdom (UK), seasonal hay fever due to grass pollen allergy accounts for
approximately 7 times more doctors' appointments than asthma. The standard treatment for hay
fever consists of treating the symptoms with a nasal spray and an antihistamine. However, in
a survey taken in a UK general practice less than 40% of patients with hay fever reported
good symptom control with this standard treatment. For those patients with hay fever whose
symptoms are not well controlled by treatment with antihistamines and nasal sprays,
subcutaneous immunotherapy (SCIT) - (monthly injections of a grass allergen extract for a
period of 3-5 years) is an effective alternative, and is approved in the UK on a named
patient basis. More recently, allergen immunotherapy tablets (AITs) have been developed,
including grass pollen allergen tablets. These have been shown to be highly effective in the
treatment of hay fever, with the additional benefit of being convenient for patients, given
that they may be taken at home. Grazax® (manufactured by Allergologisk Laboratorium København
(ALK)-Abello, Denmark) has UK and European Union (EU) license for use in the treatment of
troublesome grass pollen induced hay fever. The aim of this research is to investigate the
effects of the AIT treatment on the immune system over time - which changes are taking place
and when in the course of treatment. This will provide insight into the complexities of the
development of allergen-specific immune tolerance - how harmful allergic responses against
innocuous substances such as grass pollen can be overridden.
Phase:
Phase 2
Details
Lead Sponsor:
Imperial College London
Collaborators:
ALK-Abelló A/S King's College London Wellcome Trust