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FDA Requires Post-Market Safety Trials for Long-Acting Beta-Agonists (LABAs)
This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.
FDA is requiring the manufacturers of Long-Acting Beta-Agonists (LABAs) to conduct five randomized, double-blind, controlled clinical trials comparing the addition of LABAs to inhaled corticosteroids versus inhaled corticosteroids alone to further evaluate the safety of LABAs when used in combination with inhaled corticosteroids for the treatment of asthma.
Four clinical trials will be conducted in adult and adolescent patients 12 years of age and older. The adult and adolescent trials will include 11,700 patients in each trial for a total of 46,800 patients. Each trial will evaluate one of the following LABA-containing drugs: 1) Symbicort (budesonide and formoterol); 2) Advair Diskus (fluticasone and salmeterol); 3) Dulera (mometasone and formoterol); and 4) Foradil (formoterol). The Foradil trial will also include treatment with fluticasone, which will be provided in a separate inhaler.
One clinical trial will be conducted in pediatric patients aged 4 to 11 years with Advair Diskus. The pediatric trial will include 6,200 patients. Patients in all trials will be treated for six months, and the primary endpoint will be a composite of serious asthma outcomes: asthma-related death, intubation, or hospitalization. The pediatric trial will also assess other relevant quality-of-life endpoints such as days of school missed and emergency room visits because of asthma-related illness.
The clinical trials will begin in 2011 and FDA expects to receive results in 2017.