Omalizumab in patients with severe asthma: the XCLUSIVE study

Background and Aims: Although the efficacy and safety of omalizumab (OMA) in uncontrolled severe allergic asthma has been demonstrated in several randomised controlled trials (RCTs), information on the treatment in a practice‐related setting is limited. Thus, the purpose of this prospective multi‐centre study (XCLUSIVE) was to investigate the efficacy, compliance and utilisation of OMA therapy in real‐life clinical practice in Germany. Methods: One hundred ninety‐five asthmatic patients initiated on anti‐Immunoglobulin E (IgE) IgE treatment were followed‐up for 6 months. Forced expiratory volume in 1 s (FEV1), exacerbation rate, days of absence, asthma symptoms [Asthma Control Questionnaire (ACQ)], a Global Evaluation of Treatment Effectiveness (GETE) and medication use were assessed. Results: Measured outcome variables improved after a 16‐week treatment period with OMA (FEV1+13.7% predicted P