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Challenges and Opportunities for Combination Therapy in Chronic Obstructive Pulmonary Disease

Pulmonary and Critical Care Medicine Section, Department of Internal Medicine, University of Nebraska Medical Center, Omaha, Nebraska

Correspondence and requests for reprints should be addressed to Stephen I. Rennard, M.D., F.C.C.P., Pulmonary and Critical Care Medicine Section, Department of Internal Medicine, 985125 Nebraska Medical Center, Omaha, NE 68198-5125. E-mail: srennard{at}unmc.edu

Advances in the understanding of chronic obstructive pulmonary disease have presented a number of novel therapeutic opportunities. More extensive use of drug combinations is likely, but the development of these therapies presents a number of challenges. In clinical trials, a combination must be tested not only against placebo but also against each of its components, and the false-positive error rate increases rapidly with multiple comparisons. Thus, more groups of subjects must be studied, and more individuals within each group must be studied, in order to ensure statistical significance. Another challenge is that the relatively slow progression of chronic obstructive pulmonary disease and the lack of specificity of commonly used outcome variables complicate the evaluation of all therapies, including combinations. In analogy to genomics and proteomics (evaluation of the pattern of expression of many things simultaneously), it may be more useful to adopt an approach that is here dubbed "clinicomics": consideration of multiple features of chronic obstructive pulmonary disease that are evaluated routinely, for example, with a well-done history and physical examination. The use of a truly multidimensional outcome parameter promises an entirely novel paradigm for the assessment of novel combinations of therapies.

Key Words: biostatistics • clinical trials • drug development • outcome measures