The usefulness of the new SOBIstat-F® device in children with severe acute asthma attacks in the emergency department: a randomized clinical trial

ABSTRACT

Introduction
Protocols for managing severe asthma exacerbations include bronchodilators (short-acting beta-2 agonists and ipratropium bromide) administered by nebulizer or pressurized metered-dose inhaler (pMDI) with a valved holding chamber, corticosteroids IV, and magnesium sulfate IV. This study aims to evaluate the effectiveness of a new device (SOBIstat-F®) for bronchodilator administration via pMDI compared with the conventional method.

Methods
A randomized superiority clinical trial was conducted in children with severe acute asthma at the emergency department. Patients were assigned to one of the following groups: pMDI-SOBx, in which they received bronchodilators in pMDI through the SOBIstat-F® device, or in pMDI with oxygen via cannula or mask (pMDI-OxStand). The primary outcome was the need for hospitalization at the end of 8 h.

Results
84 patients participated in the study, of which 43 were treated with the pMDI-SOBx device and 41 with pMDI-OxStand. There were no baseline differences between the groups. Children treated with pMDI-SOBx had a lower hospitalization rate compared to those with pMDI-OxStand (9.3% vs. 26.8%, respectively, p = 0.036; absolute risk difference: -17.5% [95% CI: -33.6 to -1.4] and OR: 0.26 [95% CI: 0.08-0.91]). Additionally, a significant clinical improvement (pulmonary score) was observed from 90 min (p < 0.001), and an increase in SpO2 was observed from 60 min (p < 0.001) in the pMDI-SOBx group. Side effects were similar.

Conclusions
For the first time, bronchodilator administration using the SOBIstat-F® device was more effective than the conventional method in reducing hospitalizations and improving the clinical condition of children with severe asthma exacerbations.