PURPOSE OF THE STUDY.
The 3-year Steroid Treatment as Regular Therapy (START) study evaluated the symptom-based cutoff of >2 days per week for starting daily inhaled steroid therapy for management of mild asthma.
Participants (N = 7138, ages 4–66 years) were from 32 countries, had mild asthma diagnosed within the past 2 years, and no previous regular corticosteroid therapy.
This post-hoc analysis of a randomized control trial comparing once-daily inhaled budesonide (n = 3577, 200 μg for ages <11 years and 400 μg for ages ≥11 years) with placebo (n = 3561) was conducted for time to first severe asthma-related event (SARE) (hospital admission, emergency treatment, or death) and change from baseline lung function. Interaction with baseline symptom frequency was investigated.
Baseline days of symptoms per week were 0 to 1 for 2184 participants (31%), 2 for 1914 (27%), and >2 for 3040 (43%). In the budesonide group, time to first SARE was longer for all symptom frequencies (hazard ratios 0.54 [95% CI: 0.34–0.86] for 0 to 1 days/week, 0.60 [0.39–0.93] for 2 days/week, and 0.57 [0.41–0.79] for >2 days/week, P = .94). The decline in postbronchodilator lung function was lower after 3 years (P = .32).
In mild, recent-onset asthma, once-daily, low-dose budesonide decreases SARE risk, reduces lung function decline, and improves symptom control similarly for children and adults with symptom frequency of ≤2 days and >2 days per week.
The occurrence of life-threatening, asthma-related events in some patients with infrequent asthma symptoms encourages consideration of daily inhaled corticosteroid treatment in selected individuals. Data for children are not reported separately, but previous publications of the START study show inclusion of 1897 children ages <11 years and 1148 children ages 11 to 17 years. Inhaled steroid side effects are not reported in this study. A direct comparison of rates of side effects between the low-dose budesonide and placebo groups in children and adults would help to weigh the potential benefits and drawbacks of low-dose daily inhaled corticosteroid treatment in individual patients with infrequent asthma symptoms.
- Copyright © 2017 by the American Academy of Pediatrics