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| Sponsors and Collaborators: |
The University of North Carolina, Chapel Hill National Institutes of Health (NIH) Genentech |
|---|---|
| Information provided by: | The University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT00287378 |
Purpose
Ozone can cause acute airway inflammation in both asthmatics and normal volunteers. However, in asthmatics ozone can cause episodes of worsening of asthma. We want to learn if chronic allergic response, known as "IgE-induced airway inflammation" is what causes the increased inflammation in response to ozone. To do this we will examine the response to ozone in a group of asthmatics treated with omalizumab, a medicine available and approved for use in people with asthma, or a placebo control. The placebo for this study is inert physiologic saline ("salt water") which contains no omalizumab. Both the omalizumab and the placebo will be administered as an injection under the skin. Omalizumab, also called Xolair, is a humanized monoclonal antibody, which means that it originally was produced in mice, then genetically engineered to look more like human than mouse antibody.
Omalizumab inactivates IgE, a protein our own immune systems make as part of allergic reactions. The purpose of this study is to test the hypothesis that omalizumab, by blocking this aspect of allergic reactions, will decrease the number of inflammatory cells in the airway after ozone challenge. We also hypothesize that omalizumab will decrease the effects of ozone on changes in lung function, mucociliary clearance (a measure of how quickly mucus clears form the airway) and airway reactivity. Airway reactivity is a measure of how sensitive the airways are to a medication used to diagnose asthma, called methacholine. We will examine these as additional information we can learn during the course of the study. This is a blinded study, meaning that neither you nor the researchers know if you get the active drug or placebo, but that information can be obtained if needed. The placebo is an injection of inert physiological saline ("salt water") which contains no omalizumab.
| Condition | Intervention |
|---|---|
|
Asthma Allergy |
Drug: omalizumab |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Effect of Ozone on Airway Inflammation in Allergic Asthmatics Treated With Omalizumab |
| Enrollment: | 1 |
| Study Start Date: | March 2006 |
| Study Completion Date: | July 2007 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: omalizumab
omalizumab as per weight and IgE
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, North Carolina | |
| Center for Environmental Medicine, Asthma and Lung Biology at the University of North Carolina | |
| Chapel Hill, North Carolina, United States, 27599-7310 | |
| Principal Investigator: | Terry L Noah, MD | The University of North Carolina, Chapel Hill |
More Information
| Responsible Party: | University of North Carolina at Chapel Hill ( Barbara Longmire, Director Office of Clinical Trials ) |
| Study ID Numbers: | GCRC-2423, HL080337-01 |
| Study First Received: | February 3, 2006 |
| Last Updated: | June 26, 2009 |
| ClinicalTrials.gov Identifier: | NCT00287378 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Hypersensitivity Anti-Asthmatic Agents Asthma |
Anti-Allergic Agents Omalizumab Inflammation |
|
Respiratory System Agents Pathologic Processes Therapeutic Uses Anti-Asthmatic Agents |
Anti-Allergic Agents Pharmacologic Actions Omalizumab Inflammation |