Study objectives: Asthmatic patients lose lung function faster than normal subjects. The effectiveness of early intervention with inhaled corticosteroids on this decline in lung function is not established in recent-onset disease. Design: The Inhaled Steroid Treatment as Regular Therapy in Early Asthma study was a randomized, double-blind study in 7,165 patients (5 to 66 years old), with persistent asthma for < 2 years to determine whether early intervention with low-dose inhaled budesonide prevents severe asthma-related events and the decline in lung function. Patients received budesonide (200 μg qd for children < 11 years old and 400 μg qd for others) or placebo for 3 years in addition to usual asthma medications. Results: Treatment with budesonide significantly improved prebronchodilator and postbronchodilator FEV1 percentage of predicted and reduced the mean declines from baseline for postbronchodilator FEV1 at 1 year and 3 years: - 0.62% and - 1.79% for budesonide and - 2.11% and - 2.68% for placebo, respectively (p < 0.001). The decline was more marked for male patients, active smokers, and patients > 18 years old, and the smallest treatment effects were in adolescents. Conclusions: Long-term, once-daily treatment with low-dose budesonide improved both prebronchodilator and postbronchodilator FEV1 in patients with recent-onset, persistent asthma, and reduced the loss of lung function over time.
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