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| |  Asthma Drug, Pulmicort Respules (Budesonide), Available In US WAYNE, PA -- October 4, 2000 -- AstraZeneca’s Pulmicort Respules™ (budesonide inhalation suspension) -- for use in children from 12 months to eight years of age -- are now available in the United States. Until recently, inhaled corticosteroids, recognized by the U.S. National Institutes of Health (NIH) as the most effective medications for the control of persistent asthma, were only approved for use in children as young as age four. On August 8th, 2000, this changed with the Food and Drug Administration's approval of AstraZeneca's Pulmicort Respules (budesonide inhalation suspension) -- for use in children from 12 months to eight years of age. "This nebulized corticosteroid provides a practical and approved way for treating very young patients with persistent asthma," said David Skoner, M.D., Chief of Allergy and Immunology at Children's Hospital of Pittsburgh. Noted Dr. Skoner, "Pulmicort Respules marks a milestone in the treatment of persistent pediatric asthma. This is a serious inflammatory lung disease. The development of an inhaled corticosteroid treatment for infants and young children with asthma has been a medical imperative." The most common chronic pediatric disease is asthma.(1) In the U.S., asthma affects nearly five million children(2) with as many as 80 percent demonstrating symptoms before the age of five.(3) Asthma care guidelines developed by NIH emphasize the importance of treating airway inflammation with inhaled corticosteroids. These medications, synthetic versions of substances in the body, reduce swelling in the airways. Previously, inhaled corticosteroid therapy as only available for children four years of age and older and typically administered with an asthma inhaler which young children may not be able to use properly. Nebulization is a popular way to administer asthma medication to very young patients. Pulmicort Respules is approved for use in the jet nebulizer, the most commonly used nebulizer in the U.S. The device utilizes pressurized air to convert Pulmicort Respules, a water-based medication, into a fine mist. A young child then can inhale the mist through a tiny face mask or a mouthpiece that is attached to the nebulizer. Pulmicort Respules is a fragrance-free, taste-free liquid packaged in a plastic container that a parent twists open and pours into a nebulizer cup. Pulmicort Respules may be taken once or twice daily. Pulmicort Respules is an anti-inflammatory medication that helps to prevent asthma symptoms and improve control asthma in infants and young children from 12 months to eight years of age. It is not a quick-relief medication (bronchodilator) and should not be used to treat an asthma attack. The FDA approval of Pulmicort Respules is based on data from three 12-week double-blind U.S. clinical studies involving 946 children 12 months to eight years of age with mild to moderate persistent asthma. Pulmicort Respules reduced the need for bronchodilators and improved the control of nighttime and daytime asthma symptoms. In clinical studies, the most common side effects included respiratory infection, runny nose, coughing, earache, viral infection, stomachache, oral thrush and nosebleeds and were not necessarily related to drug treatment. The incidence of side effects was similar to that seen with a non-medicated mist (placebo). The NIH's Expert Panel Report II on the Diagnosis and Management of Asthma considers inhaled corticosteroids to be the most effective anti-inflammatory therapy today for control of persistent asthma. The development of inhaled corticosteroids has allowed physicians the ability to target inflamed airways. "Asthma must be treated appropriately -- otherwise children may suffer the risks of life-threatening asthma attacks," noted Dr. Skoner. "Of course, children with asthma should be monitored when taking inhaled corticosteroids or any product that has pharmacologic activity. Then, the benefits and risks should always be assessed." Studies have shown that Pulmicort Respules is safe and effective when used daily. When inhaled corticosteroids like Pulmicort Respules are given over long periods of time, delayed growth may occur in some children. The long term effect on final adult height is unknown. Dosing with an inhaled corticosteroid should be reduced to the lowest amount necessary to help maintain asthma control. If children are switched to Pulmicort Respules from an oral corticosteroid (syrup or tablet), they need to be carefully monitored by their physicians to avoid health risks associated with stopping the use of an oral corticosteroid. Pulmicort Respules has been used in 34 countries worldwide. Pulmicort Turbuhaler® (budesonide inhalation powder), which uses the same active compound as Pulmicort Respules, was launched by AstraZeneca as the first dry-powder, CFC-free corticosteroid inhaler in the U.S. in 1998. References: Related Links: Pulmicort Respules (budesonide inhalation suspension) and AstraZeneca.
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