BPAP Intervention Flops in Asthma Study

Children with acute asthma exacerbations who received bilevel positive airway pressure (BPAP) in the emergency department (ED) needed continuous albuterol therapy for a similar duration as those receiving sham BPAP with minimal pressure, a randomized trial showed.

At the time of a prespecified interim analysis with 50% enrollment, those in the BPAP group received a mean 8.3 hours of continuous albuterol therapy compared with 8.7 hours in the control group (P=0.84), reported Patrick T. Wilson, MD, MPH, and colleagues at the University of Colorado Anschutz School of Medicine in Aurora, in JAMA Network Open.

There were also no statistical differences in pediatric respiratory assessment measure (PRAM) or vital signs over time, length of stay, or adverse events observed between the two study arms.

“The results of the study may indicate that early BPAP commenced in the ED offers no clinical benefit in acute pediatric asthma exacerbations,” Wilson and colleagues wrote. “However, sham BPAP may not have accurately represented true control because it still delivers low pressures and provides a sealed interface over the nose and mouth, delivering heated and humidified gas flow, which potentially contributes to physiologic reversal of acute asthma exacerbations.”

“Although the use of sham BPAP was safe, it may not be the best option in future [randomized trials] given the potential positive benefits it may provide,” they pointed out.

Patients with severe asthma frequently receive continuous beta-agonist therapy in the pediatric intensive care unit (PICU), but longer therapy duration confers risks that include tachycardia, diastolic hypotension, and lactatemia, the authors noted.

“Any intervention that decreases the duration of continuous beta-agonist therapy will not only directly benefit the patient clinically but also decrease the consumption of acute care resources,” they added.

Asthma accounts for about 140,000 to 230,000 hospital admissions each year. In 2017, the estimated direct cost for asthma-related hospitalizations in children was $3.9 billion, with a median cost of $28,322 per admission to the PICU.

Wilson and team included 66 patients ages 5 to 17 years who were prescribed continuous albuterol therapy between June 2023 and May 2025. Median age was 10.2, 53% were boys, 31.8% were white, and 31.8% were Black or African American. Mean PRAM was 5.2 (minimum 4 for enrollment).

Patients were randomly assigned to either true BPAP or sham. The intervention group started on an inspiratory positive airway pressure of 10 cm H₂O and an expiratory positive airway pressure of 5 cm H₂O, and this was titrated per the blinded physician. Those in the control group had a BPAP with an orifice restrictor that limited inspiratory positive airway pressure to 2.1 cm H₂O and expiratory positive airway pressure to 1.2 cm H₂O.

Participants in the intervention group continued to receive BPAP for up to 4 hours or until weaned off continuous beta-agonist therapy, while continuation of BPAP after 4 hours in the control arm was up to the treating clinician.

Those weighing at least 20 kg received 15 mg/hour of continuous albuterol, and those weighing less received 10 mg/hour. After Pediatric Asthma Scores improved by 2 points or dropped below 7, therapy was reduced to intermittent inhaled albuterol.

Given preliminary data showing a mean duration of 24 hours for continuous beta-agonist therapy in moderate to severe pediatric exacerbations, the investigators aimed “to detect a clinically meaningful difference of at least 10 hours less the mean duration of continuous albuterol therapy in patients treated with BPAP (i.e., 24 vs 14 hours).” A futility analysis at 50% enrollment was prespecified, with termination planned “if the lower bound of the 95% CI for the treatment-control difference at the interim was greater than 50% of the mean in the control arm.”

Futility was determined and the trial was terminated since “it was highly unlikely that the mean number of hours receiving continuous albuterol would be found significantly between the groups,” Wilson and team noted. Since some patients did not receive treatment because of improvement or equipment failure, the investigators conducted a per-protocol analysis of 59 patients, with 34 receiving BPAP and 25 receiving sham, which showed similar findings.

Adverse events were typical for therapy; no serious events occurred.