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| |  First Corticosteroid Dry Powder Inhaler For Asthma Now Available In U.S. WESTBOROUGH, MA -- February 19, 1998 -- Astra USA, Inc. announced today the availability of Pulmicort Turbuhaler(R), the first corticosteroid dry powder inhaler for asthma available to physicians and patients in the United States. The product’s inhalation-driven system delivers the medication without the use of propellant gases such as chlorofluorocarbons (CFCs). A multi-national ban has been placed on the production of CFCs, which are being phased out of asthma inhalers. Pulmicort Turbuhaler treats airway inflammation, the underlying cause of asthma and is indicated for the maintenance treatment of asthma as prophylactic therapy for adults and children six years and older. In addition, Pulmicort Turbuhaler is indicated for patients requiring oral corticosteroid therapy for asthma. When the patient closes his or her lips around the mouthpiece of Pulmicort Turbuhaler and breathes in, air drawn through the device delivers fine, dry powdered medication into the lungs. No co-ordination is required between activating the device and inhaling, as with many other asthma inhalers. Additionally, Pulmicort Turbuhaler contains 200 doses, a dose indicator (showing when it is empty), twice daily dosing and no taste or smell upon delivery of the medication. Asthma experts including the U.S. National Heart, Lung and Blood Institute's National Asthma Education and Prevention Program (NAEPP) emphasised the importance of treating airway inflammation underlying asthma with inhaled corticosteroids in guidelines they issued in 1997. "Every day, there is more evidence that reducing airway inflammation is crucial to improving the health and quality of life for people with asthma," explained Stanley Szefler, M.D., director of Pediatric Clinical Trials, National Jewish Medical and Research Center in Denver. "The medication delivered to the lungs by devices such as Pulmicort Turbuhaler and the simplicity of use that I have seen with my own patients benefit both children and adults with asthma." In clinical trials involving 273 patients, Pulmicort Turbuhaler was shown to be effective in reducing chronic airway inflammation using two important measures. Patients using 200 mcg of Pulmicort Turbuhaler twice daily over 12 weeks were able to reduce their use of beta-2-agonist medication, commonly known as bronchodilators, for acute asthma episodes by approximately 50 percent and Pulmicort Turbuhaler improved patients' nighttime symptom scores by approximately 50 percent. Overall, more than 1,300 patients participated in U.S. clinical trials of Pulmicort Turbuhaler. Incidence of adverse events with Pulmicort Turbuhaler at 200 mcg twice daily, 400 mcg twice daily, 800 mcg twice daily and with placebo was as follows: respiratory infection -- 20 percent, 24 percent, 19 percent, 17 percent; headache -- 14 percent, 13 percent, 14 percent, seven percent; oral candidiasis -- two percent, four percent, four percent, two percent; dysphonia -- one percent, two percent, six percent, zero percent; and pharyngitis -- 10 percent, nine percent, five percent, nine percent, respectively. Inhaled corticosteroids have long been recognised by doctors as safe and effective anti-inflammatory medications for asthma. As with any inhaled corticosteroid, however, if patients are switched to these medications from systemic steroids, they need to be carefully monitored by their doctors to avoid health risks associated with stopping other use of systemic steroids. More information on: Pulmicort Turbuhaler, Astra USA, Inc.
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