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Comparison of serious inhaler technique errors made by device-na?ve patients using three different dry powder inhalers: a randomised, crossover, open-label study

机译:初治患者使用三种不同的干粉吸入器对吸入器技术造成的严重错误的比较:一项随机,交叉,开放标签的研究

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Serious inhaler technique errors can impair drug delivery to the lungs. This randomised, crossover, open-label study evaluated the proportion of patients making predefined serious errors with Pulmojet compared with Diskus and Turbohaler dry powder inhalers. Patients ≥18?years old with asthma and/or COPD who were current users of an inhaler but na?ve to the study devices were assigned to inhaler technique assessment on Pulmojet and either Diskus or Turbohaler in a randomised order. Patients inhaled through empty devices after reading the patient information leaflet. If serious errors potentially affecting dose delivery were recorded, they repeated the inhalations after watching a training video. Inhaler technique was assessed by a trained nurse observer and an electronic inhalation profile recorder. Baseline patient characteristics were similar between randomisation arms for the Pulmojet-Diskus (n?=?277) and Pulmojet-Turbohaler (n?=?144) comparisons. Non-inferiority in the proportions of patients recording no nurse-observed serious errors was demonstrated for both Pulmojet versus Diskus, and Pulmojet versus Turbohaler; therefore, superiority was tested. Patients were significantly less likely to make ≥1 nurse-observed serious errors using Pulmojet compared with Diskus (odds ratio, 0.31; 95?% CI, 0.19–0.51) or Pulmojet compared with Turbohaler (0.23; 0.12–0.44) after reading the patient information leaflet with additional video instruction, if required. These results suggest Pulmojet is easier to learn to use correctly than the Turbohaler or Diskus for current inhaler users switching to a new dry powder inhaler. ClinicalTrials.gov Identifier: NCT01794390 (February 14, 2013)
机译:严重的吸入器技术错误会损害药物向肺部的输送。这项随机,交叉,开放标签的研究评估了与Diskus和Turbohaler干粉吸入器相比,使用Pulmojet发生预定义严重错误的患者比例。 ≥18岁的哮喘和/或COPD的患者,他们是目前吸入器的使用者,但对研究设备不了解,被随机分配到Pulmojet和Diskus或Turbohaler上进行吸入器技术评估。阅读患者信息传单后,患者通过空设备吸入。如果记录到可能影响剂量输送的严重错误,他们会在观看培训视频后重复吸气。吸入器技术由训练有素的护士观察员和电子吸入曲线记录仪评估。 Pulmojet-Diskus(n?=?277)和Pulmojet-Turbohaler(n?=?144)比较的随机分组之间的基线患者特征相似。 Pulmojet与Diskus以及Pulmojet与Turbohaler的病例均显示出无劣势,没有记录到护士观察到的严重错误。因此,优越性得到了检验。在阅读患者后,使用Pulmojet与Diskus(比值比,0.31; 95%CI,0.19-0.51)或Pulmojet与Turbohaler(0.23; 0.12-0.44)相比,患者发生≥1个护士观察到的严重错误的可能性要小得多如果需要,还提供带有附加视频说明的信息传单。这些结果表明,对于当前的吸入器用户而言,改用新的干粉吸入器时,Pulmojet比Turbohaler或Diskus更易于学习正确使用。 ClinicalTrials.gov标识符:NCT01794390(2013年2月14日)

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