Although inhaled glucocorticosteroids are recommended and commonly used for more severe forms of persistent asthma, their long-term effect on recent onset, mild, persistent asthma is uncertain. Investigators from 7 countries performed a randomized, double-blind, placebo-controlled study of 7,241 patients in 32 countries to assess the effects of budesonide in patients who had not had previous regular treatment with corticosteroids and had symptoms of mild asthma for less than 2 years. Mild asthma was defined as wheeze, cough, dyspnea, or chest tightening at least once per week, but not daily. The patients ranged in age from 5–66 years, 3,195 of whom were under 18 years; 1,640 received budesonide and 1,535 received placebo once daily for 3 years in addition to their usual asthma medications. The daily budesonide dose was 400 μg or 200 μg for children under 11 years.
Budesonide significantly reduced the risk of a first severe asthma-related event by 44% for all patients. After 3 years, 117 patients in the budesonide group had at least 1 severe asthma-related event compared with 198 patients on placebo. Nine patients in the budesonide group and 24 in the placebo had a life-threatening exacerbation. In addition to study treatment, 45% of patients on placebo received inhaled, oral, or systemic corticosteroids during the study compared with 31% on budesonide, and this medication was prescribed earlier in the placebo group than in the active treatment group (P<.001). Compared with those in placebo, patients taking budesonide had significantly improved pre- and post-bronchodilator FEV1 after 1 and 3 years, though this declined over time. Eleven patients died during the study, 3 budesonide and 8 placebo, although only 1 death (placebo group) was directly related to asthma. Children in the budesonide group aged 5-15 years grew less than those in the placebo group (0.43 cm/year).
The increasing prevalence, morbidity, and potential mortality of asthma demands that we vigorously pursue every avenue that may lead to a decrease in morbidity and mortality of this ubiquitous entity. This study supports current recommendations by the National Asthma Education and Prevention Program for the use of low-dose, inhaled corticosteroids in mild persistent asthma.1 Initial concerns over the negative growth patterns produced by inhaled corticosteroids have been ameliorated by studies demonstrating that, despite these initial decrements in growth, children on budesonide achieved normal adult height.2,3