Clinical Trial of 3 Days of Treatment with Oral Pseudoephedrine for the Common Cold in the Southern Hemisphere

Abstract

Background Single-dose studies indicate that pseudoephedrine (PSE) provides moderate relief for congestion in coryza, but there is a lack of repeated-dose studies. Methods Two hundred sixteen subjects participated in this double-blind, randomized placebo-controlled trial over 3 days. Measurements included posterior rhinomanometry, acoustic rhinometry, and subjective measures of congestion using a categorical scale and visual analog scale (VAS). Treatment was with one 60-mg PSE tablet four times daily or matching placebo. Results After the first dose, PSE relative to placebo consistently showed small improvements for all objective assessments of nasal congestion. The prespecified primary efficacy outcome (day 1 nasal airway resistance area under the curve) was not significantly different between groups. PSE produced a 5.5% (p = 0.031) increase in total nasal volume for 0.5–3 hours after dosing. A pooled analysis of days 1 and 3 data showed a VAS score decrease of 7.0% (p = 0.072) for the 0.5- to 3-hour period on PSE. Conclusion PSE showed small but nonsignificant improvements in objective assessments of nasal congestion relative to placebo after a single dose.