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©2013 UpToDate ® Print Email Study design of pivotal trials of omalizumab The adult pivotal trials were identical in terms of study design and included four distinct phases: run-in, steroid-withdrawal, and double-blind extension. During the run-in phase, patients' standard therapy was switched to inhaled budesonide (BDP) and stabilized, which required the investigator to adjust the BDP dose so that the patients entered the core study period (steroid-stable phase) symptomatic yet exacerbation-free. Reproduced with permission from: Busse, WJ. Anti-immunoglobulin E (Omalizumab) therapy in allergic asthma. Am J Respir Crit Care Med 2001; 164:S12. Copyright © 2001 American Thoracic Society.