Oommen A, Lambert P, Grigg J. Lancet. 2003;362:1433–1438
Purpose of the Study.
To determine whether a parent-initiated, short course of oral prednisolone treatment for viral wheeze decreased mean 7-day daytime and nighttime lower respiratory symptom scores among children 1 to 5 years of age.
Children 1 to 5 years of age who were admitted for treatment of viral wheeze, which was defined as an acute episode of wheezing that occurred within 2 days of coryzal upper respiratory tract symptoms, were studied.
Children were recruited for this double-blind, randomized, placebo-controlled trial from the University Hospitals of Leicester National Health Service Trust Hospital. A pediatrician confirmed the diagnosis of rhinitis and wheeze. Blood samples were obtained from recruited patients, for determination of eosinophil cationic protein (ECP) and eosinophil protein X (EPX) levels. Patients were stratified with respect to eosinophil priming, to investigate whether high-risk patients would demonstrate greater responses to corticosteroids. On the basis of ECP and EPX levels, patients were stratified to a high-primed stratum (ECP levels of ≥20 g/L or EPX levels of ≥40 g/L) or a low-primed stratum (ECP levels of <20 g/L or EPX levels of <40 g/L). Patients in the high-primed stratum were considered at high risk for developing persistent wheeze. Patients were then randomized to receive 5 days of oral prednisolone (20 mg) or placebo treatment. Parents were told to initiate medication for the next episode of viral wheezing. Parents recorded daytime and nighttime lower respiratory tract symptoms for 7 days after the initiation of trial medication. Inhaled salbutamol was administered to patients as needed, and parents were instructed to record use. The children’s physicians could substitute orally administered prednisolone if it was deemed clinically necessary. Patients who did not experience an episode of viral wheezing within 12 months after randomization were withdrawn from the study.
Of the 230 children who were randomized, 121 completed the study protocol and were included in the data analysis. There was no difference in mean 7-day daytime and nighttime symptom scores between the prednisolone group and the placebo group. There was no difference between the 2 groups in salbutamol usage, substitution of trial medication for oral prednisolone therapy, or parental opinions regarding the efficacy of treatment. There was a trend toward increased hospitalizations in the prednisolone group, but this was not significant. Stratification of children into high-primed and low-primed groups did not demonstrate any differences in outcomes.
A parent-initiated, short course of oral prednisolone therapy did not have any benefit among children with viral wheeze, compared with placebo. This was true also when children were stratified into groups with high and low eosinophil priming.
Wheezing among preschool-aged children with respiratory tract illnesses is common. Many of these children may be treated with corticosteroids for alleviation of symptoms. However, this study shows that parent initiation of oral corticosteroid therapy for their children is not efficacious. Correctly diagnosing wheeze among preschool-aged children can be difficult. Therefore, parents may be initiating treatment on the basis of faulty diagnoses. At this time, it seems prudent for preschool-aged children who develop wheeze to be examined by their doctors, for diagnosis of wheeze and initiation of treatment