Grazax Asthma Prevention (GAP) Study - Final Version 30/06/2009

• Research type

  Research Study

• Full title

  A Randomised,parallel-group,double-blind,placebo-controlled,multi-national,Phase III trial investigating the asthma preventing effect of Grazax compared to placebo in children with grass pollen induced rhinoconjunctivitis

• IRAS ID

  28169

• Contact name

  Graham Roberts

• Sponsor organisation

  ALK-Abelló

• Eudract number

  2009-011235-12

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  It is well established that seasonal allergic rhinitis (hay fever) is a risk factor for the development of asthma and therefore treating the allergic reaction to grass pollen that results in hay fever could represent a means to prevent the development of asthma. Very few previous trials have addressed this possibility and therefore, the present trial aims at investigating the effect of this treatment on the risk of developing asthma in childhood. The trial population comprises of children aged 5 to 12 years, diagnosed with grass induced rhinoconjunctivitis (hay fever) without any asthma. The aim of the trial is to investigate if 3 years continuous treatment with Grazax can delay or prevent the onset of asthma symptoms compared to those on placebo treatment. Three years treatment is the recommended treatment period. The study will continue for two further years after treatment is completed to enable the long term benefit of therapy to be assessed. During the 5 years of the study, the patients will visit the clinic approximately 15 times. Half the patients will receive active treatment with Grazax and half will receive placebo. All patients will have access to optimal standard hay fever treatment throughout the study. As the aim of the study is to ascertain if the onset of asthma can be delayed in the active group, respiratory symptoms and lung function will be closely monitored throughout. If a patient develops asthma, they continue in the study receiving optimal asthma medication and disease management. The study will be performed in secondary care, in paediatric allergy clinics or designated research units.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  09/H0502/111

• Date of REC Opinion

  4 Dec 2009

• REC opinion

  Further Information Favourable Opinion