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

• 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