ABSTRACT
Given the potential importance of acute exacerbations of chronic obstructive pulmonary disease (AECOPD) on disease biology, expression, and progression, properly designed studies are crucial. In general, trials in this arena have focused on the treatment of acute episodes or prevention of future events. There are similar issues in the design of trials for both of these clinical scenarios, including case definition and the modalities used to assess response to therapy. On the other hand, distinct differences exist in the statistical approaches used to power studies and the patient populations examined.
