Synexus (Formerly Radiant Research), Cincinnati, OH, USA.
Clinical Development and Medical Affairs, GlaxoSmithKline Consumer Healthcare, Warren, NJ, USA.
Adv Ther. 2019 Aug;36(8):1975-1985. doi: 10.1007/s12325-019-01005-5. Epub 2019 Jun 17.
Two multicenter, double-blind, randomized controlled trials assessed the effect of Breathe Right Nasal Strips (BRNS) on sleep-related quality of life in otherwise healthy subjects with chronic nocturnal nasal congestion who reported trouble sleeping.
Subjects were randomized to BRNS or a placebo strip for approximately 8 h each night for 14 days. Efficacy was assessed in the clinic using the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ).
A total of 140 subjects were randomized in Study 1, and 130 in Study 2. There was no significant difference between BRNS and placebo on either the NRQLQ "Sleep Problems" domain or the "Feel Tired and Unrefreshed" item of the "Symptoms on Waking in the Morning" domain at day 7 or 14. There was, however, a significant change in the least squares mean difference from baseline to days 7 and 14 in both the BRNS and placebo arms for each of these endpoints. BRNS were well tolerated.
BRNS did not significantly improve subjective measures of sleep quality and nasal congestion compared with placebo strips in this population of chronic nocturnal congestion sufferers with self-reported sleep impairment, possibly due to a strong placebo effect.
GlaxoSmithKline Consumer Healthcare. CLINICALTRIALS.
Study 1: NCT03549117; Study 2: NCT03549130.
两项多中心、双盲、随机对照试验评估了 Breathe Right 鼻贴（BRNS）对报告睡眠困难的慢性夜间鼻塞且健康的受试者的睡眠相关生活质量的影响。
受试者随机分配到 BRNS 或安慰剂贴，每晚约 8 小时，持续 14 天。使用夜间鼻炎生活质量问卷（NRQLQ）在诊所评估疗效。
共有 140 名受试者被随机分配到研究 1，130 名受试者被随机分配到研究 2。在第 7 天或第 14 天，BRNS 与安慰剂在 NRQLQ“睡眠问题”域或“早晨醒来时的症状”域的“感觉疲倦和不清醒”项目上，均无统计学差异。然而，在这两个终点，BRNS 和安慰剂组的从基线到第 7 天和第 14 天的最小二乘均值差异均有显著变化。BRNS 耐受性良好。
与安慰剂贴相比，BRNS 并未显著改善报告有睡眠障碍的慢性夜间鼻塞患者的睡眠质量和鼻塞的主观测量指标，这可能是由于强烈的安慰剂效应。
葛兰素史克消费者保健公司。临床试验。
研究 1：NCT03549117；研究 2：NCT03549130。
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