A new bronchodilator delivery device, SOBIstat-F, reduced hospitalization rates and improved clinical outcomes in children with severe acute asthma, according to a randomized clinical trial presented at the European Academy of Paediatrics (EAP) 2025.

The study, conducted in two pediatric emergency departments in Asunción, Paraguay, involved 84 pediatric patients treated for severe asthma exacerbations. The children were randomly assigned to receive bronchodilators either via the new SOBIstat-F device (pIDM-SOBx) or through conventional oxygen therapy (pIDM-OxStand).

Both groups received standard bronchodilator therapy, but the key difference was in the mode of delivery. The SOBIstat-F integrates continuous oxygen flow with simultaneous bronchodilator administration via a pressurized metered-dose inhaler, which allows for simultaneous oxygen and medication delivery without removing the mask. Conventional care required clinicians to alternate between oxygen and spacers or nebulizers, which potentially affected consistency of medication delivery. 

Children who were treated with SOBIstat-F vs those treated conventionally had a lower hospitalization rate (9.3% vs 26.8%; P = .036). Clinical improvement in pulmonary scores was noted by 90 minutes (P < .001), and oxygen saturation improved after 60 minutes (P < .001).

Lead study investigator Ricardo Iramain, MD, professor of clinic pediatrics at the Hospital de Clínicas at the National University of Asunción, said the findings highlight a practical and affordable advance for pediatric emergency care.

“There aren’t any barriers for integrating the SOBIstat-F device into emergency department protocols for acute asthma attacks,” said Iramain.

Iramain said that the product can be reused up to 20 times over a 7-year lifespan, making it “very economical and quite competitive with nebulizers or metered-dose inhaler valve-holding chamber masks used for emergency intervention, which are not reused.”

Side effects such as increased heart rate and throat irritation were comparable between the two groups, suggesting that the device is as safe as standard care, the researchers noted.

“One of the main advantages of SOBIstat is that it offers a steady flow of oxygen and uniform delivery of the drug into the airways,” Iramain said.

Unlike other oxygen masks, “it is not necessary to remove the face mask to administer the spray,” he added.

According to Iramain, both clinicians and families responded positively to the device.

“They found the use of SOBIstat very practical — that’s why we could do our trial,” said Iramain. “Our results showed better oxygenation, fewer relapses, and fewer hospitalizations.”

The SOBIstat-F device has received FDA and Health Canada clearance, and is commercially available in the US and Canada.

Karalyn Kinsella, MD, pediatrician at Pediatric Associates of Cheshire in Cheshire, Connecticut, said the findings are intriguing but preliminary.

“In our offices and in pediatric emergency rooms, we often are using duo nebs [a combination of two different types of bronchodilators], which take a long time and children are often not compliant,” Kinsella said, adding that bronchodilators may take more time to administer for younger children who can’t tolerate medication delivery and mask use.

“If this device is easier to use and provides a quicker method of administering a bronchodilator, then I do think this would be very useful.”

However, Kinsella said that cost and accessibility could be barriers to widespread use.

She also pointed out that the trial’s small sample size and lack of detail about participants’ health histories limit how broadly the results can be applied.

“It was a very small sample size, and it was not delineated whether these children had complex medical histories, had positive flu, COVID, or RSV [respiratory syncytial virus], and exactly what the ages were,” Kinsella said. “It would need to be a more comprehensive, large study for me to be convinced it would be worth the switch.”

Iramain said his team is planning larger trials. “We are preparing to initiate multicenter trials to validate these findings and assess long-term outcomes,” he said.

Iramain and Kinsella reported having no disclosures.

Lara Salahi is a health journalist based in Boston.