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Sponsors and Collaborators: |
National Jewish Health Novartis |
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Information provided by: | National Jewish Health |
ClinicalTrials.gov Identifier: | NCT00851370 |
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).
Condition | Intervention | Phase |
---|---|---|
Pulmonary Disease, Chronic Obstructive |
Drug: Omalizumab (Xolair) Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 40 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | February 2011 |
Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Omalizumab: Experimental |
Drug: Omalizumab (Xolair)
Bi-weekly
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Placebo: Placebo Comparator |
Drug: Placebo
Bi-Weekly
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Ages Eligible for Study: | 40 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Christina Schnell, BA | 303-398-1772 | schnellc@njhealth.org |
United States, Colorado | |
National Jewish Health | Recruiting |
Denver, Colorado, United States, 80206 | |
Principal Investigator: Russell P Bowler, MD, PhD |
Principal Investigator: | Russell P Bowler, MD, PhD | National Jewish Health |
Responsible Party: | National Jewish Health ( Russell Bowler MD, PhD ) |
Study ID Numbers: | NJ-241 |
Study First Received: | February 4, 2009 |
Last Updated: | February 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00851370 History of Changes |
Health Authority: | United States: Institutional Review Board |
Exacerbation COPD |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Respiration Disorders Anti-Asthmatic Agents |
Chronic Disease Anti-Allergic Agents Omalizumab Pulmonary Disease, Chronic Obstructive |
Respiratory System Agents Disease Attributes Respiration Disorders Anti-Asthmatic Agents Anti-Allergic Agents Pharmacologic Actions Lung Diseases, Obstructive |
Pathologic Processes Respiratory Tract Diseases Lung Diseases Therapeutic Uses Chronic Disease Pulmonary Disease, Chronic Obstructive Omalizumab |