Usefulness of the new SOBIstat-F® device in children with severe acute asthma attacks in the Emergency Department: A randomized clinical trial.

Background: Current protocols for the management of severe asthma exacerbations include step therapy with bronchodilators (short-acting beta 2-agonists, and ipratropium bromide) administered by nebulizer or meter doses inhaler (MDI) with a valved holding chamber, corticosteroids, and magnesium sulfate EV. This study aims to evaluate the effectiveness of a new device (SOBIstat-F ® ) for bronchodilator administration via MDI compared to the conventional method. Methods: A randomized clinical trial was conducted in children with severe acute asthma seen in two pediatric emergency departments. Patients were assigned to one of the following groups: MDI-SOBx in which they received bronchodilators in MDI through the SOBIstat-F® device, or in MDI with oxygen via cannula or mask (MDI-OxStand). The main outcome was the need for hospitalization at the end of 8 hours of treatment. Results: 84 patients participated in the study, of which 43 were treated with the MDI-SOBx device and 41 with MDI-OxStand. There were no differences in demographic characteristics or severity of the exacerbations between the groups. Those children treated with MDI-SOBx had a lower hospitalization rate versus those with the MDI-OxStand (9.3% vs. 26.8%, respectively, p=0.036). Also, a significant clinical improvement (pulmonary score) was observed from 90 minutes (p<0.001) and oxygen saturation from 60 min (p<0.001) in children in the MDI-SOBx group. Side effects were similar. Conclusions: The administration of bronchodilators using the SOBIstat-F ® device demonstrated, for the first time, to be more effective than the conventional method in reducing hospitalizations and in the clinical improvement of children with severe asthma exacerbations.