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Questions

Questions. 1. Do the data provide substantial convincing evidence that Advair Diskus (fluticasone/salmeterol inhalation powder) 500/50 mcg increases survival when used in the chronic treatment of patients with COPD?. Pulmonary-Allergy Drugs Advisory Committee May 1, 2007. Questions.

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Questions

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  1. Questions 1. Do the data provide substantial convincing evidence that Advair Diskus (fluticasone/salmeterol inhalation powder) 500/50 mcg increases survival when used in the chronic treatment of patients with COPD? Pulmonary-Allergy Drugs Advisory Committee May 1, 2007

  2. Questions 1a. If not, what additional data should be obtained?

  3. Questions 1b. Is additional dosing information needed (e.g., efficacy of Advair 500/50 vs. Advair 250/50)?

  4. Questions 2. Do the data provide substantial convincing evidence that Advair Diskus (fluticasone/salmeterol inhalation powder) 500/50 mcg provides a clinically meaningful decrease in the incidence of COPD exacerbations when used in the chronic treatment of patients with COPD?

  5. Questions 2a. If not, what additional data should be obtained?

  6. Questions 2b. Is additional dosing information needed (e.g., efficacy of Advair 500/50 vs. Advair 250/50)?

  7. Questions 3. Do the data provide sufficient evidence that Advair Diskus (fluticasone/salmeterol inhalation powder) 500/50 mcg provides substantial advantage for the treatment of patients with COPD when compared to salmeterol alone?

  8. Questions 4. Does the increased incidence of respiratory infections and pneumonia seen in these studies warrant additional evaluation?

  9. Questions 4a. If so, what additional data should be obtained?

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