Asthma · Inhaled steroids in mild asthma
Early intervention with budesonide in mild persistent asthma
| Design | Randomised, double-blind, placebo-controlled trial |
|---|---|
| Treatment | Budesonide 400 µg once daily (200 µg in children under 11) |
| Control | Placebo, added to usual asthma therapy |
| Population | 7241 patients aged 5 to 66 in 32 countries with mild persistent asthma of less than two years' duration and no previous regular inhaled glucocorticoid; 7165 analysed |
| Follow-up | 3 years |
| Primary endpoint | Time to first severe asthma-related event |
| Result | Severe exacerbations occurred in 198 of 3568 on placebo and 117 of 3597 on budesonide — hazard ratio 0.56 (95% CI 0.45 to 0.71, p<0.0001). Budesonide reduced courses of systemic corticosteroids and increased symptom-free days. Postbronchodilator FEV1 rose by 1.48% predicted at 1 year and 0.88% at 3 years versus placebo. In children under 11, three-year growth was 1.34 cm less with budesonide, the deficit accruing mainly in year 1 (0.58 cm, then 0.43 cm and 0.33 cm). |
| Secondary endpoints | Systemic corticosteroid courses, symptom-free days, lung function |
Long-term, once-daily treatment with low-dose budesonide decreases the risk of severe exacerbations and improves asthma control in patients with mild persistent asthma of recent onset.
The trial authors, in the published abstract
Over seven thousand patients followed for three years, and it made inhaled steroids standard from the point of diagnosis rather than after failure. Two caveats belong with it: the lung function gains are small and shrink over time, so this prevents attacks rather than altering the trajectory; and children under 11 grew 1.34 cm less over three years, which is the principal objection to treating mild childhood asthma from diagnosis. SYGMA 1 and SYGMA 2 later showed comparable protection from as-needed treatment.
Pauwels RA, Pedersen S, Busse WW, et al. Early intervention with budesonide in mild persistent asthma: a randomised, double-blind trial. Lancet 2003 Mar 29;361(9363):1071-6.