exploratory study of xolair in chronic obstructive pulmonary disease in patients with elevated ige levels

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the objective is to conduct an exploratory study on the effect of omalizumab on copd patients with elevated ige. exploratory outcomes include to determine whether omalizumab use: reduces exacerbations in copd patients; or improves rescue medication use, decreases ics use, modified medical research council (mmrc) dyspnea score, st. george's respiratory questionnaire (sgrq), 6-minute walk distance (6mwd), forced expiratory volume at one second (fev1)(the latter 3 with bmi make up the bode score), residual volume (rv), total lung capacity (tlc), exhaled nitric oxide (eno), and determination c-reactive protein (crp).


Eligibility criteria:
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

Keywords: copd exacerbation