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Comparisons of the efficacy, onset and duration of action of fexofenadine and montelukast are limited. This study evaluated the pharmacodynamic properties of these agents in an allergen-induced wheal-and-flare model. This randomized, placebo-controlled, crossover study was composed of three treatment periods and two visits on consecutive days for each period, with each period separated by a 14-day (±4) washout. At each treatment visit, subjects received a predose allergen skin-prick test followed by either a single dose of fexofenadine HCl 180 mg, montelukast sodium 10 mg, or placebo. Allergen skin-prick testing was performed at 20, 40, and 60 minutes, then hourly through 12 hours and at 23 hours and 24 hours postdose. Adults (n = 48) with positive skin-prick tests were included in the analysis. Significant flare inhibition occurred from 40 minutes through 24 hours postdose for fexofenadine versus placebo (p < 0.05), whereas montelukast did not reach statistical significance for flare inhibition at any time point compared with placebo. Significant wheal inhibition occurred from 60 minutes through 24 hours postdose for fexofenadine versus placebo (p < 0.0012); montelukast did not significantly suppress wheal versus placebo at any time point. Fexofenadine had greater suppression than montelukast for both wheal and flare from 40 minutes through 24 hours (p < 0.05). Maximum suppression of flare and wheal reached 79.0 and 72.3% for fexofenadine, and 7.3 and 9.6% for montelukast. Fexofenadine suppressed the allergen-induced wheal-and-flare response to a significantly greater extent, and had a significantly faster onset of action, compared with montelukast.
Document Type: Research Article
Publication date: May 1, 2005
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