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A proof-of-concept study to assess the putative dose response to topical corticosteroid in persistent allergic rhinitis using adenosine monophosphate challenge.

机译:使用一磷酸腺苷激发评估持续性过敏性鼻炎中局部皮质类固醇的假定剂量反应的概念验证研究。

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INTRODUCTION: The aim of this proof-of-concept study was to assess whether nasal adenosine monophosphate (AMP) challenge may be used to quantify dose response to topical fluticasone propionate (FP) in persistent allergic rhinitis (PER). METHODS: Eligible subjects with PER entered a randomized double-blind crossover study of 2 weeks of intranasal FP at 100 microg or 400 microg daily, with a 2-week placebo washout period before each randomized treatment. Measurements after each washout or treatment comprised: peak nasal inspiratory flow (PNIF) response to nasal AMP (the primary outcome), domiciliary PNIF, the mini rhinoconjunctivitis quality of life questionnaire (miniRQLQ), symptom scores, nasal nitric oxide levels and overnight urinary cortisol:creatinine ratios. RESULTS: Thirteen patients completed per protocol. Maximal PNIF response to AMP was attenuated 0.9% (95% confidence interval -7.1 to 9.0, P=NS) by FP 100 microg, and 12.9% (4.8-20.9, P=0.009) by FP 400 microg. The 400-100 microg difference was12.0% U (2.6-21.3, P=0.049). None of the other outcomes were responsive enough to detect any significant treatment effects. The standardized response means to FP 400 microg were 81% for AMP challenge, 54% for domiciliary PNIF, 53% for miniRQLQ, 24% for symptom scores and 18% for nasal nitric oxide. No adrenal suppression was detected at either dose. CONCLUSION: FP exhibited dose-related suppression of nasal airway hyperresponsiveness to AMP challenge, but without associated detectable adrenal suppression at the higher dose. Moreover, the AMP response demonstrated the highest signal to noise ratio compared with other outcome measures in PER.
机译:简介:这项概念验证研究的目的是评估是否可以使用鼻腔一磷酸腺苷(AMP)攻击来量化持续性变应性鼻炎(PER)对局部丙酸氟替卡松(FP)的剂量反应。方法:符合条件的PER受试者参加了一项随机双盲交叉研究,该研究为期2周,每日100微克或400微克的鼻内FP,每次安慰剂治疗期为2周。每次冲洗或治疗后的测量包括:对鼻AMP的最大鼻吸气流量(PNIF)(主要结局),住所PNIF,微型鼻结膜炎生活质量问卷(miniRQLQ),症状评分,鼻中一氧化氮水平和过夜尿皮质醇:肌酐比率。结果:每项方案完成了13例患者。 FP 100 microg对AMP的最大PNIF响应衰减了0.9%(95%置信区间-7.1至9.0,P = NS),FP 400 microg对AMPIF的响应最大衰减了12.9%(4.8-20.9,P = 0.009)。 400-100微克的差异为12.0%U(2.6-21.3,P = 0.049)。其他结果都没有足够的反应性来检测任何显着的治疗效果。对FP 400 microg的标准应答方法是:AMP挑战为81%,家系PNIF为54%,miniRQLQ为53%,症状评分为24%,鼻腔一氧化氮为18%。两种剂量均未检测到肾上腺抑制作用。结论:FP对AMP激发表现出剂量相关的鼻气道高反应性抑制作用,但在高剂量时没有相关的可检测的肾上腺抑制作用。此外,与PER中的其他结果指标相比,AMP响应显示出最高的信噪比。

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