Pauwels RA, et al. Early intervention with budesonide in mild persistent asthma. Lancet. 2003. PMID 12672309

One-paragraph summary

START randomized 7,241 participants aged 5–66 with recent-onset mild persistent asthma to once-daily budesonide or placebo for three years, added to usual therapy. Severe asthma-related events occurred in 117/3,597 budesonide versus 198/3,568 placebo recipients, HR 0.56 (95% CI 0.45–0.71). Budesonide reduced systemic-steroid courses and increased symptom-free days. Lung-function differences were statistically significant but small; in children under 11, three-year growth was 1.34 cm less, concentrated in the first year.

Key findings

• Relative severe-event reduction was 44%; the absolute event proportions were 3.3% versus 5.5%.
• Post-bronchodilator FEV1 advantage was 1.48 percentage points at year 1 and 0.88 at year 3.
• Attack prevention was more clinically prominent than the average lung-function change.

Limitations

• Background “usual therapy” and adherence may differ from contemporary anti-inflammatory reliever care.
• The trial predates current asthma definitions and mild-disease reliever options.
• Growth and efficacy estimates apply to the studied molecules/doses and should not be generalized mechanically.

Why it matters

START established that mild symptoms do not imply negligible future risk and that low-dose ICS changes clinically important outcomes. It also quantifies the treatment tradeoff: substantial attack prevention alongside a small early growth effect in children.

Cited by wiki pages

• mild and moderate asthma
• clinical trials landscape