TORONTO-- Oral prednisone is more effective than inhaled fluticasone for severe acute asthma in children, a new study shows.[1] "The findings were quite striking," said lead author Suzanne Schuh, MD, an Associate Professor of Pediatrics at the University of Toronto in Canada. Dr. Schuh noted that the hospitalization rate was three times higher among the children who got inhaled fluticasone than among those who got oral prednisone. She added, "Lung function was a lot better in the prednisone group, too."

The findings suggest that physicians should avoid substituting inhaled fluticasone for oral prednisone in children with severe acute asthma, a common practice prompted by concern about the latter's side effects. In fact, Dr. Schuh and her colleagues strongly recommend that fluticasone or other inhaled corticosteroids not be used for treating severe asthma in the emergency department.

The randomized, double-blind study included 103 children (mean age, about 9.5 years) who presented to the emergency department with severe acute asthma. All the children were at least 5 years of age, had a baseline forced expiratory volume in one second (FEV1) less than 60% of predicted, and were able to use an inhaler and undergo pulmonary function tests reliably. To be included in the study, all the children had to be evaluated in the presence of a nurse researcher.

At baseline, 51 children were given oral prednisone syrup (2 mg/kg, up to a maximum of 60 mg). The remaining 52 received 2 mg of inhaled fluticasone through an inhaler and spacer with a mouthpiece. Both groups were also given placebos designed to resemble the other drug.

Within 20 minutes before baseline, at baseline, and at 20, 40, 60, 80, and 140 minutes afterward, all of the children inhaled 0.15 mg/kg of albuterol from a jet nebulizer. The first three nebulizer treatments also delivered 250 µg of ipratropium bromide. The children were assessed hourly for four hours after the start of treatment.

RESULTS FAVOR PREDNISONE

The primary outcome measure--the change in FEV1 (expressed as a percentage of predicted)--increased in both groups, but the improvement was significantly greater in the prednisone group (Table 1). At four hours after treatment, for example, this measurement had risen by a mean of 18.9 percentage points in the prednisone group versus 9.4 percentage points in the fluticasone group. Furthermore, none of the children in the prednisone group experienced a decline in FEV1 during the four-hour observation period, but 25% of those in the fluticasone group did.

The peak expiratory flow rate and forced vital capacity (both of which were measured as a percentage of predicted) also rose in the two groups; once again, however, the increase was significantly greater in the children given prednisone. The two forms of treatment produced a similar small decline in the respiratory rate, and neither had any impact on oxygen saturation.

Prednisone administration was also associated with a markedly lower rate of hospitalization (10% vs 31% in the fluticasone group). Surprisingly, 50 children in the fluticasone group, but only 14 in the prednisone group, experienced adverse events, such as vomiting, tremor, or a need for intravenous hydration.

Thirty-nine children--13 fluticasone recipients and 26 prednisone recipients--completed the home phase of the study, in which they continued their corticosteroid and albuterol treatment for seven days after discharge. When these children returned for follow-up on day 8, FEV1 had improved by 42.1 percentage points from baseline in the prednisone group and 37.6 percentage points in the fluticasone group.

A limitation of this study is that only 103 children were included; 8,001 children with severe acute asthma were actually seen in the emergency department during the study period. However, the vast majority of the excluded children were either too young or were not evaluated in the presence of a research nurse. Thus, it is unlikely that their exclusion would have altered the study's findings.

FUTURE RESEARCH

Now that oral prednisone has been proved superior to inhaled fluticasone for severe acute asthma, the next step, said Dr. Schuh, is to compare the two drugs in children with mild acute asthma. "We are preparing a protocol for just that purpose," she noted.

--Timothy Begany

Reference
1. Schuh S, Reisman J, Alshehri M, et al. A comparison of inhaled fluticasone and oral prednisone for children with severe acute asthma. N Engl J Med. 2000;343:689-694.