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

• Status: Withdrawn
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Jewish Health
• Collaborator: Novartis
• Treatments: Omalizumab

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