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| |  Once-Daily Pulmicort Turbuhaler Significantly Improves Asthma Control WAYNE, PA -- July 27, 1999 -- A once-daily treatment regimen using AstraZeneca PLC’s inhaled corticosteroid, Pulmicort Turbuhaler(R) (budesonide inhalation powder) in adult patients with stable, mild to moderate asthma showed significant improvement in asthma control, according to results in a newly published study in this month’s issue of the Journal of Allergy and Clinical Immunology. The study formed the basis of the United States Food and Drug Administration's approval last year of the first and only once-daily dosing indication for an inhaled corticosteroid. Based on this trial as well as other supportive studies submitted to the FDA, the agency approved the addition of the simple, once-daily treatment option for Pulmicort Turbuhaler in adults and children six years of age and older with mild to moderate asthma who are well-controlled by an inhaled corticosteroid. Prior to this approval, the recommended dosing regimen for the entire class of inhaled corticosteroids had been two to four times a day. "Optimal management of chronic, mild-to-moderate asthma with inhaled steroids may include use of the lowest possible doses, as recommended in guidelines, and a reduction in the frequency of daily administration for greater convenience,” the researchers write. In the 18-week U.S. trial involving 309 adults with mild to moderate asthma, patients received either Pulmicort Turbuhaler (400 mcg or 200 mcg) once-daily or placebo for six weeks. After the initial six-week period, treatment was continued unchanged for an additional 12 weeks in the placebo and 200 mcg groups. The 400 mcg group was reduced to 200 mcg for this 12-week period. The study demonstrated significant decrease in bronchodilator use (a medication used to relieve asthma attacks), significant increase in lung function and improved asthma symptom control in those patient groups treated with Pulmicort Turbuhaler. The most commonly reported adverse effects were respiratory infection, headache and bronchospasm, similar to those seen in studies evaluating twice-daily dosing. Researchers concluded that Pulmicort Turbuhaler, in doses as low as 200 mcg once-daily, may be an appropriate introductory or maintenance dose in patients with stable, mild-to-moderate asthma. Pulmicort Turbuhaler treats airway inflammation, the underlying cause of asthma, and is indicated for the control of asthma in adults and children aged six years and older. Pulmicort Turbuhaler is not a bronchodilator and is not intended to treat asthma attacks. The medication has been used for long-term control of asthma in children and adults for over 15 years world-wide. Inhaled corticosteroids, like Pulmicort Turbuhaler, have long been recognised by physicians as safe and effective anti-inflammatory medications for asthma. As with any medication, however, the benefits and risks should be understood. Patients on inhaled corticosteroids should be monitored for any potential side effects and the dose reduced to the lowest amount necessary to maintain effective control. If patients are switched to these medications from systemic steroids (tablets), they need to be carefully monitored by their physicians to avoid health risks associated with stopping the use of systemic steroids.
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