PEDIATRICS Vol. 56 No. 5s November 1975, pp. 935-936
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Application of Challenge Methods to the Evaluation of New Drugs

Joseph Oren M.D.1

1 Department of Pediatrics, Stanford University School of Medicine, and the Syntex Research Corporation, Palo Alto, California

Exercise-induced bronchspasm (EIB), as opposed to asthma precipitated by exercise, is a valuable laboratory tool in the study of the newer pharmacologic agents being developed for asthma therapy. EIB is uniquely suited for the screening of agents with cromolyn-sodium-like activity prior to extended clinical drug studies in large patient populations. To be used meaningfully, the challenge technique must be subjected to rigorous controls, standardization, and evaluation in preselected patient populations. Because of the inherent variability of the method, careful study design and the use of double-blind statistical controls are necessary to minimize misleading placebo effects.