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Trial Information
Summary: A Phase IIIb multicenter, randomized, double-blind, placebo-controlled study of Xolair in subjects with moderate to severe persistent asthma who are inadequately controlled with high-dose inhaled corticosteroids and long-acting beta agonists (EXTRA)
This clinical research study is seeking participants whose asthma is inadequately controlled with a standard treatment combination of high-dose inhaled corticosteroids and long-acting beta-agonists, such as those in the combination drug Advair®. The EXTRA Study will evaluate if subcutaneous injections of an investigational drug given as add-on therapy to standard asthma treatments can safely and effectively reduce the number of asthma attacks and improve asthma symptoms in patients with moderate to severe persistent allergic asthma.
Patients who qualify for participation after a two- to four-week observational period will have a 50 percent chance of being assigned to one of the study’s two treatment groups. One group will receive standard treatment plus the investigational drug for 48 weeks, while the other group will receive standard treatment plus placebo for 48 weeks. Placebo is a solution that looks like the study drug but does not contain the study drug. Compensation is up to $800.
If you, or someone you know, may be interested in enrolling, speak with your doctor or visit www.AsthmaBWH.org to complete a short screening. You can also call 1-888-99-ASTHMA or email us at ARC@Partners.org
Eligibility Criteria: Moderate to Severe Asthmatics, between ages 12 and 75
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Contact:
Gautham Marigowda, MD, MPH
BWH - Brigham and Women's Hospital
75 Francis Street
Boston, MA 02115
Telephone: 617-732-8201
Email:
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If you would like to learn more about participating in this study, please send an e-mail message using the form below.
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Trial listings updated: November 24, 2008 at 2:08:08 PM
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