Efficacy of a device for training metered dose inhaler breathing proficiency: a crossover, double-blind, pilot trial in healthy volunteers
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Keywords
metered dose inhaler, MDI, breathing proficiency, NU_spiroBreathe
Abstract
Background: The accurate administration of inhalation medications, including metered dose inhalers (MDI), is crucial for achieving desired treatment outcomes in patients with chronic airway diseases. A simple, inexpensive, and validated device for measuring respiratory force, the NU_spiroBreathe (NUB), has been invented. Although preliminary use of NUB indicated its potential as a training tool for improving breathing proficiency among MDI users, its efficacy in this application has not yet been studied. Objective: This study aimed to examine the efficacy of NUB in training MDI breathing proficiency among healthy volunteers. Methods: A mixed-method pilot study was conducted, combining a crossover, double-blinded, placebo-controlled trial with an AI-assisted qualitative study. Healthy participants were instructed to perform oral inhalation using NUB, a placebo MDI (pMDI), and a NUBassisted MDI (NUB-MDI) in a crossover manner. MDI breathing proficiency was assessed by measuring inhalation time (Ti) and inhalation force (Fi). Cardiopulmonary safety was evaluated using blood pressure (BP), heart rate (HR), and arterial oxygen saturation (SpO2). Participants’ opinions on NUB and other interventions were collected via a self-administered questionnaire. Results: A total of 30 participants completed the trial. They were healthy adults with an average age of 22.05 years, predominantly females. None of them had experience with any oral inhalation medications. Compared to the pMDI, the mean Ti for both NUB and NUB-MDI were statistically higher with the mean differences of 6.73 seconds [95% confidence interval (CI) 3.22 to 10.245, p < .001] and 6.10 seconds [95%CI 3.00 to 9.20, p < .001], respectively. While no significant difference in Ti was found between NUB and NUB-MDI, the mean Fi for NUB-MDI was marginally higher than that of the NUB group (mean difference of 1.48 cmH2O, [95%CI 0.36 to 2.60, p = .011]). Cardiopulmonary parameters showed no statistical changes. Content analysis of participants’ opinions corroborated the quantitative findings. Conclusion: The NUB device could serve as a useful training tool for improving MDI breathing proficiency. However, further studies in real-world clinical settings were warranted (registration number: TCTR20230401004)
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