Chest
Volume 124, Issue 3, September 2003, Pages 790-794
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Clinical Investigations
ASTHMA
A Randomized Controlled Trial of Inhaled Flunisolide in the Management of Acute Asthma in Children

https://doi.org/10.1378/chest.124.3.790Get rights and content

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 (FEV1) 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. χ2 showed no significant difference in symptom severity between the two groups at any time during the study. FEV1 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.

Section snippets

Materials and Methods

A randomized, masked, placebo-controlled, parallel-group study was conducted in 55 children aged 6 to 16 years seeking care for an acute exacerbation of asthma. Patients were excluded from enrollment if they had underlying lung disease such as cystic fibrosis or bronchopulmonary dysplasia. Patients were also excluded if they required hospital admission or had an initial FEV1 <25% or > 80% of predicted.

Baseline spirometry, peak expiratory flow (PEF), heart rate, respiratory rate, pulse oximetry,

Results

A total of 58 subjects were enrolled, of whom 35 were male and 49 were African American. Baseline asthma severity, race, gender, and age were balanced between the two treatment groups (Table 1). Twelve patients (seven patients in the ICS group) were enrolled who were routinely receiving maintenance doses of ICS. Prior use of ICS did not alter the study results.

Contingency analysis showed no significant difference in symptom severity between the two groups at any time during the study.

Discussion

Earlier studies suggest that high-dose ICS are as effective as OCS in treating acute asthma in adults24,25 and children,26,27,28,29 although data regarding pediatric asthma were not as clear.30 In a study comparing budesonide, 1,600 μg/d, by Turbuhaler (Astra; Lund, Sweden), or oral prednisone, 2 mg/kg, therapy in children with acute asthma, there was an earlier response in those treated with budesonide as measured by pulmonary index scores and PEF. They also found serum cortisol levels were

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    Presented at the American Academy of Pediatrics 2000 Annual Meeting, Chicago, IL; October 27–31, 2000.

    Funded by a grant from Forest Laboratories.

    Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (e-mail: [email protected]).

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