PURPOSE:This study was undertaken to compare the clinical efficacy and safety of high dose inhaled Fluticasone propionate versus intravenous hydrocortisone in the treatment of severe asthma exacerbation in children.
METHODS:This is a randomized double-blind placebo-controlled trial conducted in the emergency department (ED) in 24 children (12 in each group). Group 1 received Fluticasone propionate (1500 mcg) 125 mcg/actuation; 4 actuations via metered-dose inhaler and spacer administered every 20 minutes for 3 doses while group 2 received a single dose of intravenous hydrocortisone (4 mg/kg; maximum of 200mg). Peak expiratory flow rate (PEFR) and Modified Pulmonary Index Score (MPIS) were assessed at baseline and at 1, 2, 3, 4, 5, and 6 hours. Mean percentages of change of the PEFR and MPIS from baseline were computed. Admission rate and adverse effects were determined.
RESULTS:The mean (+ SD) baseline PEFR was 40.22 + 8.23 in the fluticasone group and 39.10 + 9.17 in the hydrocortisone group with a mean increase of 41.8 + 29.9 percent in the fluticasone group and 65.9 + 60.0 percent in the hydrocortisone group, six hours after therapy. Mean baseline MPIS was 12.75 + 1.06 in the fluticasone group and 13.08 + 1.16 in the hydrocortisone group with a final reduction from baseline score of almost 60 percent for both groups. No significant differences in PEFR and MPIS were noted between the two groups over time. Five (42 percent) of the children treated with hydrocortisone were admitted, as compared with two (17 percent) of those treated with fluticasone (not statistically significant, p=0.370). No adverse events were seen in both groups.
CONCLUSION:Data suggest comparable efficacy of high dose inhaled fluticasone and intravenous hydrocortisone in improving PEFR and reducing MPIS in children with severe asthma exacerbation.
CLINICAL IMPLICATIONS:Use of high dose inhaled corticosteroids in acute severe asthma in children may offer advantages of ease of administration and reduced systemic side effects as compared to systemic corticosteroids. Further studies are needed to evaluate its role in children.
DISCLOSURE:Vivian Ancheta, No Financial Disclosure Information; No Product/Research Disclosure Information