Acute exacerbation of asthma is one of the most common medical reasons for emergency department visits in children. In this setting, standard therapy consists of supplemental oxygen, inhaled beta2-adrenergic agonists, anticholinergic agents and, usually, systemic corticosteroids. Corticosteroids, whether oral or inhaled, have been shown to decrease hospitalizations and prevent progression of symptoms in children with acute asthma. Because of concerns about the safety of repeated doses of systemic steroids, there has been a growing trend toward the use of inhaled steroids as an alternative therapy. However, the data to support this practice are limited. Schuh and colleagues performed a study to compare the efficacy of inhaled fluticasone with oral prednisone in children with severe acute asthma.
Children enrolled in the study were seen in a pediatric emergency department with a diagnosis of acute asthma. The children were at least five years of age and had a forced expiratory volume in one second (FEV1) of less than 60 percent of the predicted value. Children were excluded who had not previously wheezed, who had received oral prednisone within the past seven days or who had already taken regular doses of inhaled corticosteroids.
Eligible children were randomized to receive a single 2-mg dose of inhaled fluticasone (via an inhaler with a spacer) or oral prednisone syrup in a dosage of 2 mg per kg. Placebo inhalers and syrup were used as well. In addition, all children received five doses of nebulized albuterol. Ipratropium bromide was added to the first three doses of albuterol.
Parents of the children who responded to the initial therapies were instructed to continue giving the inhaled steroid or prednisone for an additional seven days after discharge. The parents of all children were instructed to continue giving albuterol via inhaler four times a day for seven days. Children who were persistently in respiratory distress four to five hours after the experimental interventions were admitted to the hospital. The primary outcome of the study was a change in FEV1 from baseline to 240 minutes. Secondary outcomes were the changes in forced vital capacity (FVC), peak expiratory flow rate, respiratory rate, oxygen saturation on room air and rate of hospitalization.
In the study, 51 children were randomized to the fluticasone group and 49 to the oral prednisone group. The mean age was nine years, with a range of five to 17 years. The FEV1 increased from baseline to 240 minutes by a mean of 19 percent in the oral steroid group (P <0.001) compared with 9.4 percent in the inhaled steroid group. Thirteen of the children in the oral prednisone group had an “excellent” response (an increase of FEV1 greater than 25 percent) but only five in the inhaled fluticasone group had such a response. In contrast, 16 in the latter group had a “poor” response (an increase in FEV1 of less than 5 percent) compared with just four children taking oral prednisone. Moreover, 25 percent of children in the inhalation therapy group actually had a reduction in baseline FEV1 at 240 minutes, whereas no children in the oral prednisone group showed a decline in FEV1. The FVC and predicted peak expiratory flow rates were also significantly greater in the oral steroid group. Following the study, 16 children (31 percent) in the fluticasone group were admitted to the hospital compared with only five (10 percent) in the prednisone group.
The authors conclude that oral prednisone is superior to inhaled fluticasone in the treatment of children with acute exacerbations of asthma. They recommend that inhaled corticosteroids not be used for children in this clinical setting.