ALK today announced the initiation of its landmark GRAZAX® Asthma Prevention (GAP) trial.

GAP will be the largest ever trial to investigate the asthma preventive effect of specific immunotherapy in children (5–12 years old) with allergic grass pollen rhinoconjunctivitis, commonly known as ‘hay fever’. The European, multicentre, placebo-controlled, double-blind trial will follow approximately 600 children with a diagnosis of grass pollen allergic rhinoconjunctivitis over a period of 5 years. It will assess the asthma preventive effect of Grazax after a 3-year course of therapy. The children will then be followed for a further 2 years to determine if this effect is sustained after completion of Grazax treatment.
Erkka Valorita, GAP Lead Investigator & Chief Paediatrician and Paediatric Allergist, Turku, Finland, highlighted that “Many children with allergic rhinoconjunctivitis go on to develop asthma, which represents a significant burden of disease often resulting in days off school, reduced school performance, increased physician visits and even hospitalisations. If positive, the trial could significantly change the way children with hay fever are treated in the future. For the first time we will have conclusive evidence from a suitably designed trial showing that treating hay fever with the grass allergy immunotherapy tablet Grazax, prevents the progression of the condition into asthma”.
Childhood allergic rhinoconjunctivitis increases the risk for asthma development in later life by up to 7-fold. The progression of allergic rhinoconjunctivitis into asthma is often known as the ‘Allergic March’.
Authorities in 27 European countries recently approved Grazax as the first registered  disease-modifying allergy immunotherapy tablet (AIT) for the management of grass pollen allergic rhinoconjunctivitis in both children and adults. This was based on data demonstrating that adults treated with a 3-year course of Grazax experienced a
sustained reduction in symptoms after the completion of treatment. If positive, the GAP trial will demonstrate that the recognised disease-modifying properties of Grazax extend to preventing the development of asthma in children with
a diagnosis of grass pollen allergic rhinoconjunctivitis. By providing the first tabletbased therapy to prevent the progression of allergy to asthma, ALK will confirm its continued commitment to advancing care for people with allergy and asthma.

Bron: ALK