Exploratory Study of Xolair in Chronic Obstructive Pulmonary Disease in Patients With Elevated IgE Levels
Information source: National Jewish Health
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Disease, Chronic Obstructive
Intervention: Omalizumab (Xolair) (Drug); Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: National Jewish Health Official(s) and/or principal investigator(s):
Russell P Bowler, MD, PhD, Principal Investigator, Affiliation: National Jewish Health
Overall contact:
Christina Schnell, BA, Phone: 303-398-1772, Email: schnellc@njhealth.org
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).
Clinical Details
Official title: Exploratory Study of Xolair (Omalizumab)to Improve Outcomes in Patients With COPD and Elevated IgE Levels, and Positive RAST or Skin Prick Tests
Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Primary outcome: COPD Exacerbations
Eligibility
Minimum age: 40 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Christina Schnell, BA, Phone: 303-398-1772, Email: schnellc@njhealth.org
National Jewish Health, Denver, Colorado 80206, United States; Recruiting
Russell P Bowler, MD, PhD, Principal Investigator
Additional Information
Related publications: Cazzola M, Dahl R. Inhaled combination therapy with long-acting beta 2-agonists and corticosteroids in stable COPD. Chest. 2004 Jul;126(1):220-37. Review. Bonay M, Bancal C, Crestani B. The risk/benefit of inhaled corticosteroids in chronic obstructive pulmonary disease. Expert Opin Drug Saf. 2005 Mar;4(2):251-71. Review. Imfeld S, Bloch KE, Weder W, Russi EW. The BODE index after lung volume reduction surgery correlates with survival. Chest. 2006 Apr;129(4):873-8.
Starting date: January 2009
Last updated: September 17, 2009
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