Randomized Clinical Trial Comparing Breath-Enhanced to Conventional Nebulizers in the Treatment of Children with Acute Asthma.

OBJECTIVE

To compare the efficacy of a breath-enhanced and a conventional jet nebulizer in the treatment of children with moderate to severe acute asthma.

STUDY DESIGN

We enrolled subjects between 6 and 18 years of age presenting to the emergency department (ED) with acute asthma and an initial forced expiratory volume in 1 second (FEV) <70% of predicted. We excluded patients with chronic disease, who required immediate resuscitation, or failed spirometry. Subjects were randomized to breath-enhanced or conventional jet delivery of a 5-mg albuterol treatment. Our primary outcome was change in FEV, and secondary outcomes included change in clinical asthma scores, ED length of stay, disposition, and side effects. Student t test and multivariable linear regression were used to evaluate the primary outcome.

RESULTS

In total, 497 patients were assessed for eligibility with 118 enrolled and 107 subjects available for analysis of the primary outcome. Improvement in FEV was significantly greater with conventional jet nebulizer (mean ΔFEV +13.8% vs +9.1%, P = .04). This difference remained significant after adjustment for baseline differences. Subgroup analysis of 57 subjects with spirometry meeting American Thoracic Society/European Respiratory Society guidelines yielded similar results (mean ΔFEV +14.5% vs +8.5%, P=.03). There were no significant differences in clinical asthma scores, ED length of stay, disposition, or side effects.

CONCLUSIONS

Albuterol delivered via conventional jet nebulizer resulted in significantly greater improvement in FEV than albuterol delivered by breath-enhanced nebulizer, without significant differences in clinical measures. Conventional jet nebulizers may deliver albuterol to children with acute asthma more effectively than breath-enhanced nebulizers.

TRIAL REGISTRATION

ClinicalTrials.gov: NCT02566902.