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

被引:20
作者
Bickford, L [1 ]
Shakib, S [1 ]
Taverner, D [1 ]
机构
[1] Univ Adelaide, Dept Expt & Clin Pharmacol, Adelaide, SA 5005, Australia
关键词
acoustic rhinometry; double-blind method; nasal airways; oxymetazoline; randomised clinical trial; rhinomanometry;
D O I
10.1046/j.1365-2125.1999.00972.x
中图分类号
R9 [药学];
学科分类号
1007 [药学];
摘要
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 rhinomano-meter. 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 AUG, 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_HUC, 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.
引用
收藏
页码:53 / 56
页数:4
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