%0 Journal Article %A Matthias Kopp %A Henrik Watz %A Kristin Lerche %T Effects of Xolair® in children: The X-HALE study %D 2013 %J European Respiratory Journal %P P1133 %V 42 %N Suppl 57 %X Introduction: The EU label for omalizumab (Xolair) was extended to children < 12 years in July 2009. The X-HALE study is a non-interventional study to observe the clinical effects of Xolair in children and adolescents (6-18 years) with severe allergic asthma.This study aimed to investigate changes in quality of life (QoL), physical activity, to collect data concerning the therapy utilization of Xolair and evaluate efficacy.Methods: The following parameters were evaluated at baseline and end of the 4–6 month study period: QoL (PAQLQ); evaluation of adolescents’ school productivity impairment; physical activity (measured over 7 days by the Sense-Wear-Pro-Armband®); practicability of administration in routine clinical practice; rate of exacerbations; emergency visits/hospitalizations; concomitant medication; physician's assessment (GETE) and adverse events.Results: A total of 18 patients (12.6 years) with SAA were included. Increases in PAQLQ scores (2.3) indicated QoL improvement. In addition, differences in teaching hours/week (+3.8) and missed school hours (-8.3) were shown.Data of 12 patients were valid for analysis of physical activity and suggested no significant treatment differences.Xolair doses and frequency of administration remained stable. Changes in co-medication were recorded in 44.4% of patients, with a reduction of ICS in 42.9%. The number of exacerbations was reduced, as were emergency visits and hospitalizations. Physicians assessed the control of asthma as excellent in 66.7% of the patients. 3 adverse events occurred, 1 (eczema) was related to Xolair.Conclusion: Xolair was associated with an improvement in QoL, reduced the number of exacerbations and was well-tolerated in children and adolescents with SAA. %U https://erj.ersjournals.com/content/erj/42/Suppl_57/P1133.full.pdf