- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00851370
Exploratory Study of Xolair in Chronic Obstructive Pulmonary Disease in Patients With Elevated IgE Levels
March 27, 2017 updated by: National Jewish Health
Exploratory Study of Xolair (Omalizumab)to Improve Outcomes in Patients With COPD and Elevated IgE Levels, and Positive RAST or Skin Prick Tests
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).
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Denver, Colorado, United States, 80206
- National Jewish Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
38 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Bi-Weekly
|
Experimental: Omalizumab
|
Bi-weekly
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
COPD Exacerbations
Time Frame: 48 weeks
|
48 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Russell P Bowler, MD, PhD, National Jewish Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1378/chest.126.1.220.
- 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. doi: 10.1517/14740338.4.2.251.
- 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. doi: 10.1378/chest.129.4.873.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Anticipated)
February 1, 2011
Study Completion (Actual)
February 1, 2011
Study Registration Dates
First Submitted
February 4, 2009
First Submitted That Met QC Criteria
February 24, 2009
First Posted (Estimate)
February 25, 2009
Study Record Updates
Last Update Posted (Actual)
March 29, 2017
Last Update Submitted That Met QC Criteria
March 27, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NJ-241
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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