A New Method for Evaluating Antitussive Medications Using the Citric Acid Challenge Technique

¹ Food and Drug Research Laboratories, Inc., Maspeth, L. I., N. Y.

A modification of the citric acid aerosol challenge procedure for assessing the potency and duration of action of antitussive medications, representing an improvement on the currently accepted technique, is reported. Instead of determining the number and intensity of coughs induced by a citric acid stimulus well over the threshold, the threshold, itself is measured. A procedure is described in which time can be used to quantitate the citric acid stimulus and to serve as the parameter for evaluating antitussive effectiveness. The method thus far has yielded consistent and significant results with trials on ten subjects, or less, using duplicate runs on occasion, with a special schedule that limits the trials to four a day, spaced at least two hours apart. The procedure shows promise of improve precision in screening new antitussive agents and in evaluating modifications of existing formulations in human subjects.

Note:

The methodology described in this report was developed under a grant from Chesebrough-Pond's, Inc., New York, N. Y. The author acknowledges the technical assistance of B. Barnett, J. Scheimberg, and E. Clemente.

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