FDA Approves Advair(R) 250/50 for Reduction of Exacerbations in Patients...(ns two medicines an inhaled corticostero...),Health

Clinical Data

Two identical one-year studies were conducted to evaluate the effect on COPD exacerbations with Advair Diskus 250/50 compared to 50 mcg of salmeterol alone, each given twice daily. A total of 1,579 patients with an established history of COPD exacerbations were enrolled. Patients treated with Advair Diskus 250/50 had a 30% reduction in the rate of annual exacerbations compared to salmeterol (p<0.001). Additionally, patients treated with Advair had a significantly lower annual rate of exacerbations requiring treatment with oral corticosteroids compared with patients treated with salmeterol (39.7% reduction [95% CI: 22.8, 52.9], p <0.001). Secondary endpoints including pulmonary function and symptom scores improved more in patients treated with Advair 250/50 than with salmeterol 50 mcg in both studies.

The studies conducted to support the new indication were one year in duration, thus lengthening the duration of established efficacy and safety in patients with COPD.

Background on COPD

An estimated 24 million Americans suffer from COPD, which is the fourth leading cause of death in the United States. COPD is a progressive, life- threatening lung disease that includes chronic bronchitis and emphysema. It is characterized by airflow obstruction, a limitation in lung function that makes it difficult to breathe. Most patients have components of both chronic bronchitis and emphysema. Symptoms of COPD include chronic cough, chest tightness, shortness of breath, an increased effort to breathe and increased mucus production. Typically, patients with COPD develop shortness of breath during exertion, which continues and gradually worsens. Most patients also develop a productive, chronic cough. Over time, m
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