Source: Annual Congress 2013 –Uncontrolled and severe asthma in children
Disease area: Airway diseases, Paediatric lung diseases

Abstract

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.

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Citations should be made in the following way:
M. Kopp, H. Watz, K. Lerche (Lübeck, Grosshansdorf, Nuremberg, Germany). Effects of Xolair® in children: The X-HALE study. Eur Respir J 2013; 42: Suppl. 57, 1133

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