Use of mouthpiece with the VR647 inhalation system in children aged 1 to 4 years

<b>Introduction:</b> It is perceived that young children have difficulty inhaling with a mouthpiece. The VR647 inhalation system (VR647IS) is a breath-actuated device for paediatric patients that guides inhalation flow rate and volume to improve delivery to the lung and provides real-time feedback to improve the patient’s inhalation technique. <b>Aims:</b> To assess if young children could use the VR647IS with a mouthpiece. <b>Methods:</b> Children aged 1–4 years with cough and/or recurrent wheeze in the past year, and who had used either a MDI with a spacer or a nebulizer, were included in this open-label study. Patients inhaled isotonic saline for nebulization using VR647IS with a mouthpiece, during two clinic visits (V1/V2), 4–8 days apart. Inhalation success was assessed at the third attempt at each visit. In a human factors study use of VR647IS with a mouthpiece and a face mask was also assessed in 15 children aged 1-8 years. <b>Results:</b> Overall, 40/41 patients attempted at least one inhalation. Most patients used VR467IS with a mouthpiece successfully (65% and 70% at V1 and V2, respectively); 90% of patients aged 3–4 years, 64% aged 2 years and 17% aged 1 year were successful at using VR647IS with a mouthpiece at V2. Most patients (89%) aged 4 years inhaled with a mouthpiece without hands-on assistance at V2 and 43% of children aged 2 years could use it without assistance. In the human factors study 80% of all participants and 83% of children aged 1-2 years were able to use VR647IS with the mouthpiece. <b>Conclusions:</b> 90% of children aged &gt; 2 years were able to use VR647IS with a mouthpiece, and 89% of children aged 4 years could use VR647IS, without assistance.