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ATS: Persistent Pediatric Asthma Better Controlled With Foradil (Formoterol Fumarate) Aerolizer SAN FRANCISCO, CA -- May 23, 2001 -- Foradil® Aerolizer™ (formoterol fumarate inhalation powder) reduced symptoms and improved disease management in children with persistent asthma uncontrolled by inhaled corticosteroids (ICS) alone. These results were presented at the 97th annual American Thoracic Society meeting here. Foradil Aerolizer was approved by the Food and Drug Administration in February 2001 and is now available by prescription. "Uncontrolled asthma drastically affects a child’s life, whether it be on the playground, in the classroom or at home," said George Bensch, M.D., a study investigator and partner in the Allergy, Immunology and Asthma Medical Group, Stockton, California. "Our research shows that by adding Foradil Aerolizer to standard ICS therapy, children can better control their disease." In the one-year study, Foradil Aerolizer produced rapid bronchodilation within five minutes that was well maintained for 12 hours. In addition, Foradil Aerolizer reduced day and nighttime asthma symptoms, and the need for rescue medication. The overall incidence of adverse events was comparable to placebo. The double-blind, placebo-controlled study included 518 children (aged five-12) with persistent asthma whose symptoms remained uncontrolled despite ICS treatment. The pediatric patients received either placebo, Foradil 12 micrograms (µg) or Foradil 24 micrograms (µg) twice a day via the Aerolizer Inhaler, followed by their established anti-inflammatory treatment. Researchers found that the addition of Foradil Aerolizer significantly improved forced expiratory volume (FEV1), the maximum volume of air expired in one second, which was the primary outcome measure of the study. When compared to placebo after three months, children taking Foradil Aerolizer had statistically significant (p<0.0001) improvement in FEV1. That improvement was maintained at one year (p<0.0062 for the 12 µg Foradil and p<0.0001 for the 24 µg), as compared with placebo. Similar statistically significant improvements for peak expiratory flow rate (PEFR), the maximum flow rate that can be generated during a forced exhalation, were also observed at three months and at one year (p<0.0001). These rates were measured before morning and evening doses of Foradil Aerolizer. The user-friendly Aerolizer Inhaler accurately dispenses a precise dose of Foradil that patients can “hear, feel and see.” In the past, patients and parents of children with asthma have been concerned about confirming that a correct dose of asthma medication has been delivered. The Aerolizer Inhaler can be visually inspected, and the inhaler makes a whirring noise, signaling that the drug is being dispensed. "In the U.S. alone, more than five million children have been diagnosed with asthma, a disease that is the second most common cause of school absenteeism, after the common cold. Foradil Aerolizer is a safe asthma therapy option for kids and its unique delivery device provides added reassurance to parents that their children are receiving the proper dose of their medication," added Dr. Bensch. The approved dosage of Foradil Aerolizer is 12 mcg, twice a day. In clinical trials, adverse reactions with Foradil Aerolizer were similar to those with other selective beta2-agonists, such as tachycardia, tremor, dizziness, insomnia and abdominal pain. Foradil Aerolizer is not a substitute for inhaled or oral corticosteroids. Foradil Aerolizer should not be used to treat acute symptoms, or used more than twice daily, and should be used with caution in patients with cardiovascular disorders. SOURCE: Novartis Pharmaceuticals Corporation Related Link: Novartis Pharmaceuticals Corporation. E-mail this page to a friend or colleague! To print, use this version