Project Title: PROTOCOL Q3662g: A Phase iiib multicenter, randomized, double‑blind, placebo‑controlled study of xolair in subjects with moderate to severe persistent asthma who are inadequately controlled with high-dose inhaled corticosteroids and long-acting beta-agonsits. Supported by: Genentech, Inc. The purpose of this research study is to assess how well the study drug, Xolair(omalizumab) works in people with asthma who still have symptoms despite treatment with both high-dose inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA). You are being asked to participate in this study because you fit in this category. The study drug is approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe asthma in patients who still have symptoms despite treatment with inhaled corticosteroids and who are allergic to certain particles in the air. The use of the study drug in addition to high-dose ICS + LABA treatment in this study is considered experimental. The study drug, Xolair (omalizumab), blocks the action of immunoglobin E (IgE). IgE is a natural antibody (protein) produced in the human body that reacts with air particles (dust, pollens) causing allergy and asthma symptoms. The study drug is designed to bind to the IgE and prevent it from starting asthmatic reactions. The study drug is given as an injection under the skin every 2-4 weeks and is designed to prevent allergic reaction to dust and pollens in the air. Your participation in this study is entirely voluntary and is expected to last up to 52 weeks. Approximately 850 subjects at approximately 150 study centers will be participating in this study, which will be completed over a period of 1 to 2 years. Here at Northwestern University we plan to recruit 15 participants. |