ALK-Abello has presented successful results from a new clinical trial, GT-12, designed to measure the impact of Grazax on allergic rhinitis and allergic asthma.
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GT-12 compared the effects of Grazax with symptomatic medication versus symptomatic medication alone on the ability to reduce symptoms of allergic rhinitis and seasonal asthma. Grazax reduced the combined asthma symptom score by 64%. The asthma symptoms included were: coughing, wheezing, chest tightening or shortness of breath (dyspnoea) and exercise-induced symptoms.
The study also showed that fewer children required asthma medication when using Grazax than those on symptomatic medication alone, however these results were not statistically significant. Participants in the study also experienced a 67% reduction in the number of days with asthma symptoms (median).
In addition, study results also demonstrated that Grazax reduced hay fever symptoms by 28% and reduced the need for symptom-relieving medication by 65% (median values) during the grass pollen season (using a threshold of 30 grains/m3).
The results show comparable effect to the results from the largest clinical trial program in adults ever conducted within allergy immunotherapy which led to a European marketing approval of the product in 2006. Currently a registration application for the pediatric use of Grazax is under submission in Europe.
Albrecht Bufe, lead investigator of the study, said: “Grazax has the potential to provide a new treatment choice in this area particularly among young patients whose symptoms may not be controlled adequately with available treatments.”
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