Ullmann Nicola, Di Marco Antonio, Columbu Fabiana, Negro Valentina, Chiarini Testa Maria Beatrice, Panetta Valentina, Tripodi Salvatore, Potapova Ekaterina, Allegorico Annalisa, Matricardi Paolo Maria, Cutrera Renato
Pediatric Pulmonology & Respiratory Intermediate Care Unit, Sleep and Long Term Ventilation Unit, Academic Department of Pediatrics, Research Institute, Bambino Gesù Children Hospital, Rome, Italy.
L'altrastatistica srl, Consultancy & Training, Biostatistics, Rome, Italy.
Front Pediatr. 2020 Dec 10;8:598690. doi: 10.3389/fped.2020.598690. eCollection 2020.
Wheezing episodes are the first causes of doctor's consultation in preschool age. Treatment is usually administered with a metered dose inhaler (MDI) spacer. At variance, many parents and doctors prefer to use a compressor nebulizer, which cannot be easily carried. The study is aimed at testing whether a pocket mesh nebulizer has similar efficacy and acceptability than a standard MDI device. The IPAC study was a randomized, controlled, non-inferiority trial (number: 1616/2018, Ospedale Pediatrico Bambino Gesu'-IRCCS). The study had two arms: cases, using MicroAIR U100, and controls, using MDI+spacer device. Both devices were adopted for long-term treatment and for exacerbations. Follow-up was organized with clinical visits and a daily e-diary connected to an application for mobile phone. One hundred patients were enrolled. The frequency of asthmatic symptoms showed a non-inferiority for MicroAIR U100 group vs. MDI. Accordingly, no significant difference was found in the average % of days with cough, wheezing, breathlessness after exercise, days lost at school, and not-programmed visits. Considering only patients with >1 day with symptoms, no significant sdifferences were found in the number of exacerbations nor in the cumulative days with symptoms. The acceptance and usability of both devices have been favorable. However, the MDI+AeroChamber® device showed better acceptability. Our study shows that MicroAIR U-100, a mesh nebulizer, has similar clinical efficacy but lower acceptance and usability than an MDI plus Aerochamber® in delivering therapy in preschool wheezers. Therefore, MicroAIR U-100 might be a valuable second choice, when the delivery of medication with an MDI plus Aerochamber® is not accepted, or wrongly used by the parents.
喘息发作是学龄前儿童就医的首要原因。治疗通常使用定量吸入器（MDI）配合储雾罐进行。不同的是，许多家长和医生更倾向于使用难以携带的压缩雾化器。本研究旨在测试便携式网状雾化器与标准MDI装置相比是否具有相似的疗效和可接受性。IPAC研究是一项随机、对照、非劣效性试验（编号：1616/2018，罗马儿童医院-IRCCS）。该研究分为两组：病例组使用MicroAIR U100，对照组使用MDI+储雾罐装置。两种装置均用于长期治疗和急性发作期治疗。通过临床随访和连接手机应用程序的每日电子日记进行随访。共招募了100名患者。MicroAIR U100组哮喘症状的发生率与MDI组相比无劣效性。因此，在咳嗽、喘息、运动后气促的天数百分比、缺课天数和非计划就诊次数方面未发现显著差异。仅考虑有症状天数>1天的患者，在急性发作次数和症状累计天数方面未发现显著差异。两种装置的可接受性和易用性都较好。然而，MDI+AeroChamber®装置显示出更好的可接受性。我们的研究表明，在为学龄前喘息儿童提供治疗时，网状雾化器MicroAIR U-100具有相似的临床疗效，但与MDI加Aerochamber®相比，其可接受性和易用性较低。因此，当家长不接受或错误使用MDI加Aerochamber®给药时，MicroAIR U-100可能是一个有价值的第二选择。
