Guidance Aids Drug Development for COPD Patients

The Food and Drug Administration has released draft guidance to help clinical trial sponsors and investigators develop antimicrobial drugs for treating acute bacterial exacerbations of chronic bronchitis in patients with chronic obstructive pulmonary disease. FDA said its thinking in this area has evolved in recent years, and the guidance will explain the changes in its recommendations; the Food and Drug Administration Amendments Act of 2007 also required FDA to publish such guidance.

Advisory committees have focused on the development of specific drugs, according to the notice FDA published last week. The guidance recommends that clinical trials be designed as superiority rather than noninferiority trials and discusses possible study designs that might be employed in a trial designed to show superiority. The guidance also discusses patient-reported outcome instruments for assessing clinical response and the use of time to resolution of symptoms as a possible approach to assessing the primary endpoint in clinical studies.

FDA said it will accept comments on the guidance until Nov. 20; submit them via www.regulations.gov or mail them to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Room 2201, Silver Spring, MD 20993-0002.

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