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 Study)

Recent studies indicate a substantial number of moderate to severe persistent allergic asthma patients are unable to control their symptoms with standard combinations of high-dose inhaled corticosteroids. These individuals often receive corticosteroids, such as prednisone, which are administered intravenously or orally and can cause side effects if used either frequently or for a long time.

The purpose of the EXTRA Study is to determine if Xolair® (omalizumab), used in combination with high-dose inhaled corticosteroids and long-acting beta-agonists, is safe and effective at reducing the rate of allergic asthma attacks that require treatment with systemic corticosteroids.

Xolair is approved by the U.S. Food and Drug Administration for the treatment of moderate to severe persistent allergic asthma in adults and adolescent patients with a positive skin test to one or more airborne allergens, and whose symptoms are inadequately controlled with inhaled corticosteroids. However, the safety and effectiveness of Xolair as add-on therapy to high-dose inhaled corticosteroids and long-acting beta agonists have not been established.

To determine if you are eligible for participation in the study, you must first enter a “run-in,” or observation, period. During this initial two- to four-week period, you must demonstrate at least two continuous weeks of inadequate allergic asthma symptom control. 

Eligible patients will continue into a 48-week treatment period. Throughout the treatment period, individuals will be randomly assigned to one of two groups. One group will continue to receive standard treatment (high-dose inhaled corticosteroids and long-acting beta agonists) with the addition of Xolair, while the other group will receive standard treatment with the addition of a placebo. A placebo is an inactive solution that looks just like the study drug but does not contain study drug.

Subjects will receive injections of the study drug or placebo beneath their skin every two or four weeks as determined by the physician in charge of the study.

You may be eligible to participate in this study if you:

• Are 12 to 75 years of age
• Have had moderate to severe asthma for at least one year
• Are on stable regimen of salmeterol 50 mcg BID or formoterol for eight weeks
• Are on high-dose inhaled fluticasone or similar for eight weeks
• Have required prednisone or a similar medication for an asthma exacerbation in the past 12 months

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via e-mail, please include the title of the study in your message.