Cetero Research, 4520 Dixie Road, Mississauga, Ontario, Canada.
Am J Rhinol Allergy. 2010 Nov-Dec;24(6):433-8. doi: 10.2500/ajra.2010.24.3548. Epub 2010 Nov 10.
Patients report nasal congestion as the most bothersome seasonal allergic rhinitis (SAR) symptom. Measurement of this symptom in previous research has largely been based on subjective patient ratings. This study was designed to measure efficacy, onset, and duration of action of the corticosteroid mometasone furoate nasal spray (MFNS) on nasal congestion using an environmental exposure chamber (EEC) and the objective assessment acoustic rhinometry (AcR).
In a randomized, double-blind, placebo-controlled study, ragweed-sensitive subjects were exposed to ragweed pollen (3500 ± 500 pollen grains/m(3)) in an EEC (day 1). Subjects rated instantaneous total nasal symptom score (TNSS), including NSS for congestion (NSS-C). Qualifying subjects received MFNS, 200 micrograms, or placebo and rated postdosing symptoms; a subset received MFNS, 200 micrograms, or placebo q.d. for 6 subsequent days, returning to EEC on day 8. Days 1 and 8 assessments included AcR, TNSS, and the Rhinoconjunctivitis Quality of Life Questionnaire developed for use in the EEC (RQOLQ-EEC).
At day 1, hour 6, patients receiving MFNS (n = 155) reported significantly reduced congestion versus placebo (n = 155) per AcR and NSS-C after one dose, showing numerically superior TNSS change from baseline (p = NS). Among the subset who received 6 additional days of treatment, MFNS (n = 78) yielded significantly lower TNSS versus placebo (n = 77) before day 8 EEC entry and throughout 4-hour exposure (p < 0.05), except at 3.5 hours. AcR showed lower congestion with MFNS versus placebo before day 8 EEC exposure and at 24 and 26 hours after final dose (p < 0.05 for all). AcR and NSS-C correlated at multiple time points. Day 8 RQOLQ-EEC between-group scores were significantly different (p = 0.02) for practical problems.
MFNS, 200 micrograms, showed onset of nasal congestion relief at 6 hours and duration of action beyond 24 hours postdosing. Objective and subjective assessments were correlated in subjects with maximal (placebo) or minimal (MFNS treatment) congestion symptoms; both assessments were correlated with improved QOL.
患者报告鼻塞是最恼人的季节性过敏性鼻炎（SAR）症状。既往研究中对该症状的测量主要基于患者的主观评分。本研究旨在使用环境暴露室（EEC）和客观评估声学鼻测量法（AcR）来测量糠秕花粉过敏患者使用皮质类固醇糠酸莫米松鼻喷雾剂（MFNS）后的鼻塞缓解效果、起效时间和作用持续时间。
在一项随机、双盲、安慰剂对照研究中，豚草敏感受试者在 EEC 中暴露于豚草花粉（3500±500 花粉粒/m3）（第 1 天）。受试者即时评估总鼻症状评分（TNSS），包括鼻塞的 NSS（NSS-C）。合格受试者接受 MFNS 200μg 或安慰剂治疗，并在给药后评估症状；一部分受试者接受 MFNS 200μg 或安慰剂 q.d. 连续 6 天，在第 8 天返回 EEC。第 1 天和第 8 天的评估包括 AcR、TNSS 和为 EEC 开发的 Rhinoconjunctivitis 生活质量问卷（RQOLQ-EEC）。
第 1 天，在第 6 小时，接受 MFNS（n=155）的患者报告鼻塞缓解与安慰剂（n=155）相比，单次剂量后经 AcR 和 NSS-C 评估，显示出具有统计学意义的改善（p=NS）。在接受 6 天额外治疗的亚组中，MFNS（n=78）在第 8 天 EEC 进入前和整个 4 小时暴露期间与安慰剂（n=77）相比，TNSS 显示出显著更低的变化（p<0.05），但在 3.5 小时除外。在第 8 天 EEC 暴露前、末次给药后 24 小时和 26 小时，MFNS 组的 AcR 显示出较安慰剂组更低的鼻塞（p<0.05）。在多个时间点，AcR 和 NSS-C 均呈显著相关性。第 8 天 EEC 的 RQOLQ-EEC 组间评分在实际问题上具有显著差异（p=0.02）。
MFNS 200μg 在给药后 6 小时即可缓解鼻塞症状，作用持续时间超过 24 小时。在最大鼻塞症状（安慰剂）或最小鼻塞症状（MFNS 治疗）的受试者中，客观和主观评估结果均呈显著相关性；两者评估均与 QOL 改善相关。
