ALK has announced the initiation of GAP, the largest-ever trial to investigate the effect of specific immunotherapy Grazax in children with allergic grass pollen rhinoconjunctivitis, commonly known as hay fever.
The onset of allergic rhinoconjunctivitis in childhood can increase the risk of asthma development in later life by up to sevenfold, a process refered to by specialists as the "Allergic March".
The European multicentre, placebo-controlled, double-blind trial will follow approximately 600 children with hay fever over a period of five years. It will assess the asthma preventive effect of Grazax after a three-year course of therapy, after which the children will be monitored for a further two years.
GAP lead investigator and chief paediatrician Erkka Valovirta said that 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 to show that treatment with Grazax prevents the progression of the condition into asthma," Valovirta said.
Grazax has been approved in 27 European countries as the first registered disease-modifying allergy immunotherapy tablet for the management of grass pollen allergic rhinoconjunctivitis in children and adults.