A randomized controlled trial of inhaled flunisolide in the management of acute asthma in children

Chest. 2003 Sep;124(3):790-4. doi: 10.1378/chest.124.3.790.


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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Disease
  • Administration, Inhalation
  • Administration, Oral
  • Adolescent
  • Anti-Asthmatic Agents / administration & dosage*
  • Anti-Asthmatic Agents / adverse effects
  • Anti-Inflammatory Agents / administration & dosage*
  • Anti-Inflammatory Agents / adverse effects
  • Asthma / drug therapy*
  • Child
  • Female
  • Fluocinolone Acetonide / administration & dosage*
  • Fluocinolone Acetonide / adverse effects
  • Fluocinolone Acetonide / analogs & derivatives*
  • Humans
  • Lung Volume Measurements
  • Male
  • Oxygen / blood
  • Prednisone / administration & dosage
  • Prednisone / adverse effects
  • Treatment Outcome


  • Anti-Asthmatic Agents
  • Anti-Inflammatory Agents
  • Fluocinolone Acetonide
  • flunisolide
  • Oxygen
  • Prednisone