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| |  FDA Approves Advair Diskus (fluticasone propionate/salmeterol) Treatment for COPD Associated with Chronic Bronchitis RESEARCH TRIANGLE PARK, NC -- November 18, 2003 -- The U.S. Food and Drug Administration (FDA) has approved Advair Diskus® 250/50 as a new treatment for a serious lung disease that affects millions of Americans - chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis. This is the first time that a product containing both an anti- inflammatory (fluticasone propionate) and a long-acting bronchodilator (salmeterol) has been approved for this condition. COPD, which includes chronic bronchitis and emphysema, is a complex lung disease that has several components: inflammation, bronchoconstriction and structural changes in the airways that restrict airflow into and out of the lungs. It is a debilitating and progressive condition that results in a loss of lung function. Until now, the only medications approved for the treatment of COPD associated with chronic bronchitis have been bronchodilators. Many COPD patients with chronic bronchitis need multiple medications to help manage their condition. Advair Diskus contains two medicines which work in different ways to improve lung function - a key goal of COPD therapy. In a clinical study, Advair Diskus 250/50 showed significantly greater improvement in lung function than the leading long-acting bronchodilator (salmeterol) used alone. Advair Diskus 250/50 is indicated for the twice daily, maintenance treatment of airflow obstruction in patients with COPD associated with chronic bronchitis. It does not replace fast-acting inhalers used to relieve sudden symptoms of shortness of breath. "The approval of Advair Diskus 250/50 for this condition is important news for patients and physicians," said William Bailey, MD, professor of medicine and director of the Lung Health Center at the University of Alabama- Birmingham. "There is growing recognition that COPD is a complex disease with multiple components. Advair offers a new approach, because it contains both an anti-inflammatory and a bronchodilator that work together to improve lung function." The two medications are combined in one breath-activated inhaler called the Diskus, which contains a built-in dose counter. Advair Diskus may make treatment more convenient: patients take just one inhalation twice a day, whereas some other treatments can require up to three inhalations four times a day. Background on COPD More than 20 million Americans are estimated to have COPD(1), and most have associated chronic bronchitis. In COPD, airways become inflamed (swollen and irritated) and clogged with mucus, which narrows the airways and makes it more difficult to breathe. At the same time, muscles around the airways constrict (bronchoconstriction), which squeezes the airways and makes them even narrower. Long-term exposure to irritants such as tobacco smoke or air pollution is the most frequent cause of COPD. A patient with COPD is considered to have associated chronic bronchitis when he or she has a productive cough on most days for a minimum of three months for at least two successive years, or for six months in one year.(2) Clinical Data The FDA approved Advair Diskus 250/50 for the treatment of COPD associated with chronic bronchitis based on data that includes the results of a clinical trial involving 723 patients. This 24-week study demonstrated that Advair Diskus 250/50 provided patients with significantly greater improvements in lung function (FEV1) than either of its component medications used alone at the same doses or placebo. Improvement in lung function - an important goal of COPD therapy - occurred after the first dose of Advair Diskus; lung function continued to improve in subsequent weeks. At endpoint, there was a significantly greater improvement in two-hour post-dose FEV1 in patients taking Advair Diskus 250/50 (27 percent, 281 mL) compared with those taking salmeterol (19 percent, 200 mL), fluticasone propionate (14 percent, 147 mL) or placebo (six percent, 58 mL). The most common side effects observed in this clinical study with Advair Diskus 250/50 were headache, candidiasis (oral thrush), musculoskeletal pain, throat irritation, lower viral respiratory tract infection and hoarseness. Patients treated with Advair Diskus 250/50 did not have a significant reduction in chronic bronchitis symptoms (as measured by the chronic bronchitis symptom questionnaire) or COPD exacerbations compared with patients treated with placebo over the 24 weeks of therapy. The benefits of treatment of patients with COPD associated with chronic bronchitis with Advair Diskus 250/50 for periods of longer than six months has not been established. The Diskus Device Unlike traditional aerosol inhalers, which propel medication at a high velocity, the Diskus device is breath-activated: patients use their own breath to inhale pre-measured doses of medication. Each Diskus device contains a 30- day supply of medication and has a built-in dose counter to help patients keep track of doses. In a study of patients with obstructive lung disease, the Diskus device was shown to deliver consistent and accurate doses of medication across a wide range of inhalation levels, even in patients with severely compromised lung function.(3) Additional Important Product Information In patients with major risk factors for decreased bone mineral content, such as tobacco use, advanced age, sedentary lifestyle, poor nutrition, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants and corticosteroids), Advair Diskus may pose an additional risk. Patients should talk with their doctor about ways to reduce their risk. Long-term use of inhaled corticosteroids, including fluticasone propionate, a component of Advair Diskus, may increase the risk of some eye problems (cataracts or glaucoma). Regular eye examinations should be considered. Advair Diskus 250/50 mcg twice daily is the only approved dosage for the treatment of patients who have COPD associated with chronic bronchitis. Higher doses, including Advair Diskus 500/50, are not recommended as no additional improvement in lung function was observed in clinical trials, and higher doses of inhaled corticosteroids increase the risk of systemic effects. References: 1. Mannino DM, et al. Chronic Obstructive Pulmonary Disease Surveillance - United States, 1971-2000. Centers for Disease Control and Prevention, MMWR Surveillance Summaries August 2, 2002;51(SS06): 1-16. 2. National Institutes of Health: National Heart, Lung, and Blood Institute. What Are Chronic Bronchitis and Emphysema" COPD Questions and Answers. 3. Data on file, GlaxoSmithKline.
SOURCE: GlaxoSmithKline
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