Recruitment for a trial investigating the preventive effect on asthma of anSQ-standardised grass allergy immunotherapy tablet in children with grasspollen induced rhinoconjunctivitis (the Grazax ® asthma prevention trial)G Roberts 1 , AKH Berstad 2 , J de Blic 3 , A Bufe 4 , P Eng 5 , S Halken 6 , P Ojeda 7 , L Tommerup 8 , E Valovirta 9 , E-M Varga 10 , I Winnergard 111Faculty of Medicine, University of Southampton, Southampton, United Kingdom; 2 Haukeland University Hospital, Bergen, Norway; 3 Hôpital Necker EnfantsMalades, Paris, France; 4 NETSTAP Research, Bochum, Germany; 5 Trimbach, Switzerland; 6 Odense University Hospital, Odense, Denmark; 7 Clínica de Asma yAlergia, Madrid, Spain; 8 Global Clinical Development, <strong>ALK</strong>, Hørsholm, Denmark; 9 Suomen Terveystalo Allergy Clinic, Turku, Finland; 10 Department of Paediatrics,Respiratory and Allergic Disease Division, Medical University Graz, Graz, Austria; 11 Pediatric Allergy Clinic, Kungsbacka, SwedenGrass AITBackgroundThe Grazax® asthma prevention (GAP) trial is designed toinvestigate whether the documented disease modifyingeffect of the SQ-standardised grass allergy immunotherapytablet (AIT), (Grazax ® , Phleum pratense, 75,000 SQ-T/2,800 BAU, <strong>ALK</strong>, Denmark) results in a preventive effecton the development of asthma in children with grass polleninduced rhinoconjunctivitis. This presentation describes therecruitment strategy and the results.MethodThe GAP trial is a randomised, placebo-controlled, parallelgroup,double-blind, multicentre, multinational trial.The trial runs over 5 years with 15 visits. Main eligibilitycriteria were age 5-12 years with grass pollen inducedrhinoconjunctivitis and no asthma or overlapping allergies.The children were to be randomised 1:1 to receive eithergrass AIT or placebo once daily for 3 years, followed byan observational period of 2 years. We planned to screen1,000 children before the start of the grass pollen season2010. This was designed to allow at least 620 childrento be randomised. A steering committee with focus onrecruitment was formed comprising investigators fromdifferent countries, and a recruitment plan was made foreach country. Plans were adjusted based on successesof the different approaches and the experiences gainedin each country and shared in the steering committee.Recruitment tools included community advertising, mediaexposure, clinic lists/databases, information meetings,study fliers, investigator focused actions, professionalnetworking and advertising at symposia and throughpaediatrician societies and patient organisations. Lateradditions were initiation of an additional country andextension of the window for the first visit.ResultThe first subject was screened on 24 November 2009. Therecruitment rate varied over time and geographically, somecountries showed a steady rate, whereas the rate increasedfor others after employment of a specific recruitment toolor as the grass pollen season neared. The screening targetwas met on 21 June 2010, resulting in 812 randomisedchildren from 101 centres in 11 countries.ConclusionThe challenging task of screening 1,000 grass pollenallergic children for possible recruitment into a 5-year trialwas successfully handled by applying country and centrespecific recruitment tools, adjusted on an ongoing basiswith experience shared between all countries.22Abstract number: 507. Session date and time: Sunday 12 June, 12.00 - 13.30Session: Poster session – Peadiatric aspects of immunotherapy. Session room: Rumeli Hall
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