Published: 2009-11-16 09:00:00 CET
ALK-Abelló - Release
ALK ANNOUNCES LANDMARK ASTHMA PREVENTION TRIAL
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 tablet-based therapy to prevent the
progression of allergy to asthma, ALK will confirm its continued commitment to
advancing care for people with allergy and asthma. 

 
For further information, please contact:

Mads Boysen
Senior Internal Communications Manager 
ALK
Bøge Allé 1
DK-2970 Hørsholm
Denmark
Mob: +45 4061 3800
Email: mbydk@alk-abello.com

Jenny Barrett
Senior Programme Executive
Axon Communications 
Hill House
Heron Square
Richmond upon Thames
Surrey TW9 1EP
United Kingdom
Direct: +44 (0)20 8439 9408
Email: jbarrett@axon-com.com


gap-trial.pdf