Exploratory Study of Xolair in Chronic Obstructive Pulmonary Disease in Patients With Elevated IgE Levels

Inclusion Criteria: * Smoking-related COPD and aged between 40 and 70 yrs. * Total IgE of 30-700 IU and a positive RAST or skin prick test result to one or more perennial environmental allergens (e.g. dust mite (Dermatophagoides farinae, Dermatophagoides pteronyssinus), cockroach, dog, or cat.) * Any race or sex; women with childbearing potential are required to use an acceptable method for birth control and have a negative pregnancy test * History of ≥2 exacerbations during 2 yrs previous to the enrollment date * An exacerbation will be defined as an increase or new onset of more than one of the following: cough, sputum, wheezing, dyspnea, or chest tightness with a duration of at least 3 days requiring antibiotic or systemic steroid treatment. The severity of an exacerbation will be determined by the following: * Mild: Home management, with or without contacting a health care provider, or unscheduled office visit * Moderate: Requiring a visit to an emergency department * Severe: Requiring hospitalization * Very Severe: Requiring intubation and medical ventilation * Post-bronchodilator FEV1 30-64% of predicted; the first 5 subjects enrolled will be required to have post-bronchodilator FEV1 50-64% * Post-bronchodilator FEV1/FVC \< 0.7 * Smokers or ex-smokers with at least a 20 pack-year smoking history * Able to communicate meaningfully with the study personnel and to understand and read fluently in English * Written informed consent; * BODE score 3-10. Exclusion Criteria: * History of Omalizumab use * Evidence of illicit drug use or abuse of alcohol. * Women of childbearing potential not using the contraception method(s) specified in this study (specify), as well as women who are breastfeeding * Known sensitivity to study drug(s) or class of study drug(s) * Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required) * Use of any other investigational agent in the last 30 days * Continuous treatment with oral corticosteroids * Participating in another trial within 3 months prior to the beginning of the study * Non-compliance in taking medications * Planned for lung transplantation at the time of admission to the study or expected to be transplanted within 3 yrs * Alpha-1-antitrypsin deficiency * Cystic fibrosis * Bronchiectasis * History of infection or active infection due to Mycobacterium tuberculosis * Pneumoconiosis * Pulmonary restriction due to any other pulmonary disease, apart from the one concerned with the study population * Congestive heart failure class 2 or more of the New York Heart Association (NYHA) * Reduced life expectancy due to other disease (defined as having an expected mortality of ≥25% five years from enrollment) * Current use of ß-blockers