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| |  First Inhaled Corticosteroid For Children Four Years And Older Cleared For Use RESEARCH TRIANGLE PARK, NC -- November 10, 1997 -- Children from four to 11 years of age who suffer from the debilitating effects of asthma have a new treatment option as a result of action taken by the U.S. Food and Drug Administration. Flovent(R) Rotadisk(R), at doses of 50 and 100 mcg twice daily, is the first and only anti-inflammatory corticosteroid medication to be cleared as preventive therapy for the maintenance treatment of asthma for children as young as four years. This is a significant step in the treatment of pediatric asthma because, until now, no anti-inflammatory corticosteroid has been indicated for children this young. "When it comes to treating children with asthma, it is important to begin treatment with an anti-inflammatory medication as early as possible," said Edwin Bronsky, M.D., co-director of the Pediatric Allergy Clinic, Primary Children's Hospital in Salt Lake City, UT. "In our studies, Flovent Rotadisk, both 50 mcg and 100 mcg twice daily, was shown to be effective and well-tolerated in children as young as four years of age who have asthma." Representing a new generation of inhaled corticosteroids, Flovent Rotadisk has a high level of anti-inflammatory action and low absorption into the bloodstream. Asthma is a serious disease that affects nearly five million children under the age of 18 years in the United States, making it the leading cause of Earlier this year, the National Institutes of Health released guidelines that advocate early use of an inhaled corticosteroid to control inflammation in the lungs because it is the most effective anti-inflammatory medication available for asthma. Furthermore, there is increasing belief that early intervention with inhaled steroids may help prevent the progression of asthma, although direct evidence is still fairly limited. This may prove to be of importance in deciding the most appropriate treatment program for young children. Flovent Rotadisk is inhaled using a specially designed plastic device called the Diskhaler(R). The Diskhaler is easy to use and is equipped with a dose counter, which may help patients better comply with their medication and help parents to monitor their child's use of medication. In addition, twice-a-day dosing may help to minimize disruption to a child's daily routine. Flovent Rotadisk is the only inhaled powder corticosteroid asthma medication that can be tailored to each patient's condition with multiple dosing strengths. "Flovent can provide effective asthma control at low doses," Dr. Bronsky said. "The availability of Flovent Rotadisk for children as young as four years of age further confirms the safety profile of Flovent in general." In addition to the 50 mcg and 100 mcg strengths, which are indicated for both children and adults, a 250 mcg strength also is available for the treatment of asthma in adults. The product is not indicated for the rapid relief of asthma attacks. In a 12-week clinical trial of 263 patients aged four to 11 years who were inadequately controlled on bronchodilators alone, Flovent Rotadisk, at doses of 50 and 100 mcg twice daily, significantly improved lung function (28 percent and 34 percent respectively) compared to placebo (11 percent). In clinical trials, the most common side effects among patients at recommended starting doses of 50 mcg, 100 mcg and 250 mcg twice-a-day were hoarseness, rhinitis, sinusitis, nasal congestion, sore throat, headache and upper respiratory infection. These side effects were mostly mild to moderate in severity. For adult patients being weaned from oral corticosteroids, particular care should be taken because adrenal insufficiency may occur when transferring to an inhaled corticosteroid.
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