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A2018 - Does Flunisolide HFA Improve Small Airway Function in Children?
Author Block: S. G. Bickel, J. Myers, R. L. Morton, A. R. O'Hagan, N. S. Eid; Pediatrics, University of Louisville, Louisville, KY, United States.
Introduction: Flunisolide is an inhaled corticosteroid which was first approved in 1981 and has since been in use as an asthma maintenance therapy. The current hydrofluoroalkane (HFA) formulation has superior lung deposition when compared to its chlorofluorocarbons (CFC) counterpart (68% versus 20%). In addition, flunisolide has no measurable effect on growth over one year. Despite these compelling attributes, there is no data focusing on the effect of flunisolide on pediatric small airway lung function parameters. Objective: To assess the impact of flunisolide on small airway parameters using spirometry and impulse oscillometry and determine whether there is a dose-related difference (320 mcg vs 160 mcg) with flunisolide HFA in pediatric patients who have evidence of small airway obstruction. Methods: We enrolled 26 pediatric patients (ages 6-18) with mild to moderate persistent asthma. Of the initial 26, 19 completed the study. Patients were naïve to inhaled steroids for at least one week and to systemic steroids for at least four weeks. Prior to enrollment, patients demonstrated evidence of small airway disease based on pre-bronchodilator FEF25-75% of less than 65% predicted. Patients were randomized to receive flunisolide at either 80mcg twice a day (160 mcg group) or 160 mcg twice a day (320 mcg group). Prior to starting therapy, baseline IOS and spirometry pre and post bronchodilator were obtained. Patients were followed for six weeks after which IOS and spirometry were repeated. The change in scores from baseline to six-week follow-up was compared using paired t-tests and Chi-squared for trend tests. Results: There were no statistically significant differences between patients enrolled in the two groups. When all subjects were analyzed together (n=19), a modest trend towards improvement was seen in R5 (p=0.15) though no outcomes reached statistical significance. When broken into subgroups, there were no within group differences nor were there any differences when comparing between the two groups. FEF25-75% showed a modest trend towards significance in the 320 mcg group (p = 0.10) not observed in the 160 mcg group (p=0.78). The small sample size in this trial may partially explain the failure to reach statistical significance. Conclusion: Our data suggests that flunisolide may have an impact on the composite measures of small airways function, with trend in improvements noted 6 weeks after starting either low or medium dose in R5 and with medium dose in FEF25-75%, though not currently statistically significant.