Status:
WITHDRAWN
Exploratory Study of Xolair in Chronic Obstructive Pulmonary Disease in Patients With Elevated IgE Levels
Lead Sponsor:
National Jewish Health
Collaborating Sponsors:
Novartis
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40-70 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00851370
Start Date
January 1 2009
End Date
February 1 2011
Last Update
March 29 2017
Active Locations (1)
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1
National Jewish Health
Denver, Colorado, United States, 80206