A randomized controlled trial of inhaled flunisolide in the management of acute asthma in children.
Author(s): Nakanishi AK, Klasner AK, Rubin BK
Affiliation(s): Department of Pediatrics, St. Louis University School of Medicine, Cardinal Glennon Children's Hospital, 1465 S. Grand Boulevard, St. Louis, MO 63119, USA. Nakanimk@slu.edu
Publication date & source: 2003-09, Chest., 124(3):790-4.
Publication type: Clinical Trial; Randomized Controlled Trial
BACKGROUND: Inhaled corticosteroids (ICS) may provide benefit in the therapy of acute asthma. The purpose of this study was to test the hypothesis that ICS are as effective as oral corticosteroids (OCS) in the management of acute childhood asthma. METHODS: A randomized, masked, placebo-controlled study was conducted in children aged 6 to 16 years seeking emergent care for an acute exacerbation of asthma. Patients were randomized into one of two groups: group 1 (OCS), oral prednisone, 2 mg/kg (maximum of 60 mg/d) for 7 days, and placebo pressurized metered-dose inhaler with valved holding chamber, four inhalations bid; and group 2 (ICS), flunisolide, four inhalations (1 mg) bid for 7 days, and daily placebo tablets. Spirometry (FEV(1)) was performed at baseline, day 3, and day 7 of the study. A symptom diary and twice-daily peak expiratory flow were recorded. RESULTS: A total of 58 subjects receiving ICS (n = 27) or OCS (n = 28) were enrolled. Baseline asthma severity, race, gender, and age were balanced between the two groups. chi(2) showed no significant difference in symptom severity between the two groups at any time during the study. FEV(1) percentage of predicted was lower in the ICS group on day 3 (65% vs 78%, p = 0.03) and on day 7 (77% vs 95%, p = 0.002). CONCLUSION: ICS were found to be useful in the management of acute asthma in children; however, spirometry data suggested a more rapid resolution of asthma with OCS.
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