The nasal airways response in normal subjects to oxymetazoline spray: randomized double-blind placebo-controlled trial

Abstract

Aims: The effects of a single dose of oxymetazoline nasal spray on nasal patency have been compared with placebo using three separate measuring systems in normal subjects.

Methods: The study was a placebo-controlled, randomised double-blind crossover trial. Subjects without ear, nose or throat disease and with resting nasal airways resistance >0.15 Pa s cm-3 were selected so that a fall in airways resistance could be detected. Nasal airways resistance (NAR) was measured by NR6-2 rhinomanometer. Acoustic rhinometry (SR-2000 rhinometer) provided the sum of the minimum cross-sectional areas (tMCA) and volume (tVOL) of the left and right nasal cavities. Symptoms of congestion were assessed on a visual analogue scale (CON, range 0-100). Measurements were made for 60 min before and for 120 min after bilateral administration of oxymetazoline nasal spray (0.9 mg) or placebo (0.9% saline). Crossover occurred 7-21 days later. Results for all measures were analysed as change from average baseline value by trapezoidal AUC, and statistical significance was tested by 2-way anova.

Results: NAR, tMCA, tVOL and CON did not change after placebo, but NAR and CON fell and tMCA and tVOL increased significantly at all timepoints after oxymetazoline. NAR_AUC, tVOL_AUC, tMCA_AUC were significantly different between placebo and oxymetazoline (P<0.001) as was CON_AUC (P=0.012). The day-to-day intraindividual repeatability of baseline NAR tMCA and tVOL was <10%.

Conclusions: Normal subjects can be used to detect the effects of nasally vasoactive drugs with a variety of complementary systems, with the advantages of easy subject recruitment and low variability.

Figures

Figure 1

NAR change from baseline at times after dosing of placebo or oxymetazoline (0.9 mg) (mean SE).

Figure 2

tVOL change from baseline at times after dosing of placebo or oxymetazoline (0.9 mg) (±s.e. mean).

Figure 3

tCSA change from baseline at times after dosing of placebo (▵) or oxymetazoline (0.9 mg, ▪) (±s.e. mean).

Figure 4

CON change from baseline at times after dosing of placebo (▵) or oxymetazoline (0.9 mg, ▪) (±s.e. mean).