The nasal decongestant effect of xylometazoline in the common cold.
BACKGROUND
Xylometazoline is a nasal decongestant spray that constricts nasal blood vessels and increases nasal airflow, enabling patients with a blocked nose to breathe more easily. The purpose of this study was to characterize objectively and subjectively the decongestant and additional effects of xylometazoline in the common cold.


METHODS
A double-blind, placebo-controlled, parallel group study was performed. Patients with a common cold (n = 61) were treated with xylometazoline 0.1% (n = 29) or placebo (saline solution; n = 32; 1 spray three times a day for up to 10 days). The primary objective was to determine the decongestant effect (nasal conductance); the secondary objectives were to determine the peak subjective effect (visual analog scale), duration of relief of nasal congestion, total and individual cold symptoms and general well-being (patients' daily diary), and adverse events (AEs).


RESULTS
The decongestant effect of xylometazoline was significantly greater than placebo, as shown by the nasal conductance at 1 hour (384.23 versus 226.42 cm(3)/s; p <or= 0.0001) and peak subjective effect (VAS, 20.7 mm versus 31.5 mm; p = 0.0298). Nasal conductance was significantly superior for up to 10 hours (p = 0.0009) and there was a trend in favor of xylometazoline for up to 12 hours (not statistically significant). Xylometazoline significantly improved total and some individual common cold symptoms scores (p < 0.05), leading to significantly greater patient general evaluation and satisfaction with treatment (p < 0.05). Nineteen AEs were reported: 8 with xylometazoline (all mild-moderate) and 11 with placebo (1 severe).


CONCLUSIONS
Xylometazoline is an effective and well-tolerated decongestant nasal spray that significantly relieved nasal congestion compared with placebo in the common cold and provided long-lasting relief with just 1 spray, helping patients to breathe more easily for a longer period of time.
Eccles
Ronald
R
Common Cold Centre & Healthcare Clinical Trials, Cardiff University, Cardiff, United Kingdom. eccles@cardiff.ac.uk
Eriksson
Margareta
M
Garreffa
Steve
S
Chen
Shirley C
SC
D000281:Administration, Intranasal; D000316:Adrenergic alpha-Agonists; D000328:Adult; D003139:Common Cold / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage*; D008297:Male; D014663:Nasal Decongestants / Q000008:administration & dosage*; D017060:Patient Satisfaction; D012189:Retrospective Studies; D016896:Treatment Outcome
D000316:Adrenergic alpha-Agonists; D007093:Imidazoles; D014663:Nasal Decongestants; C009695:xylometazoline