Effect of Ozone on Airway Inflammation in Allergic Asthmatics Treated With Omalizumab

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT00287378
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • omalizumab — DRUG
    omalizumab as per weight and IgE

Study Details

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.

Key Dates

Start date
Mar 31, 2006
Status verified
Feb 2009
Primary completion
Jul 31, 2007
Completion
Jul 31, 2007

Study Design

Enrollment
1 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: 1

Primary Outcome Measure

The primary efficacy endpoint (increase in airway neutrophils) will be assessed by comparison of the differences between sputum neutrophil influx after ozone (adjusted for post air challenge neutrophils) between omalizumab and placebo treated volunteers [ Time Frame: 16 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Center for Environmental Medicine, Asthma and Lung Biology at the University of North CarolinaChapel HillNorth Carolina27599-7310-

Find similar trials in Chapel Hill, NC

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
Center for Environmental Medicine, Asthma and Lung Biology at the University of North Carolina· Chapel Hill, NC

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