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.

• Authors: Jenny Latte, David Taverner
• Journal: American journal of rhinology (Am J Rhinol) 2007 Jul-Aug Vol. 21 Issue 4 Pg. 452-5 ISSN: 1050-6586 [Print] United States
• PMID: 17882915 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Vasoconstrictor Agents
• Pseudoephedrine

Topics

• Adolescent
• Adult
• Aged
• Australia
• Common Cold (drug therapy)
• Double-Blind Method
• Female
• Humans
• Male
• Middle Aged
• Pseudoephedrine (administration & dosage)
• Treatment Outcome
• Vasoconstrictor Agents (administration & dosage)