Exploratory Study of Xolair in Chronic Obstructive Pulmonary Disease in Patients With Elevated IgE Levels
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Omalizumab (Xolair)
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Pulmonary Disease, Chronic Obstructive focused on measuring COPD, Exacerbation
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
Sites / Locations
- National Jewish Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Omalizumab
Placebo
Arm Description
Outcomes
Primary Outcome Measures
COPD Exacerbations
Secondary Outcome Measures
Full Information
NCT ID
NCT00851370
First Posted
February 4, 2009
Last Updated
March 27, 2017
Sponsor
National Jewish Health
Collaborators
Novartis
1. Study Identification
Unique Protocol Identification Number
NCT00851370
Brief Title
Exploratory Study of Xolair in Chronic Obstructive Pulmonary Disease in Patients With Elevated IgE Levels
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 Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to find eligible subjects- study closed
Study Start Date
January 2009 (undefined)
Primary Completion Date
February 2011 (Anticipated)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Jewish Health
Collaborators
Novartis
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
COPD, Exacerbation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omalizumab
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Omalizumab (Xolair)
Other Intervention Name(s)
Xolair
Intervention Description
Bi-weekly
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Bi-Weekly
Primary Outcome Measure Information:
Title
COPD Exacerbations
Time Frame
48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Russell P Bowler, MD, PhD
Organizational Affiliation
National Jewish Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15249466
Citation
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.
Results Reference
background
PubMed Identifier
15794718
Citation
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.
Results Reference
background
PubMed Identifier
16608932
Citation
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.
Results Reference
background
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Exploratory Study of Xolair in Chronic Obstructive Pulmonary Disease in Patients With Elevated IgE Levels
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