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Abstract
Although inhaled glucocorticosteroids are recommended for persistent asthma, their
long-term effect on recent onset, mild, persistent asthma has yet to be established.
We did a randomised, double-blind clinical trial in 7241 patients in 32 countries
to assess the effects of budesonide in patients who had had mild persistent asthma
for less than 2 years and who had not had previous regular treatment with glucocorticosteroids.
Patients aged 5-66 years received either budesonide or placebo once daily for 3 years
in addition to their usual asthma medications. The daily budesonide dose was 400 microg,
or 200 microg for children younger than 11 years. The primary outcome was time to
first severe asthma-related event, and analysis was by intention to treat.
198 of 3568 patients on placebo and 117 of 3597 on budesonide had at least one severe
asthma exacerbation; hazard ratio 0.56 (95% CI 0.45-0.71, p<0.0001). Patients on budesonide
had fewer courses of systemic corticosteroids and more symptom-free days than did
those on placebo. Compared with placebo, budesonide increased postbronchodilator forced
expiratory volume in 1 s (FEV1) from baseline by 1.48% (p<0.0001) after 1 year and
by 0.88% (p=0.0005) after 3 years (expressed as percent of the predicted value). The
corresponding increase in prebronchodilator FEV1 was 2.24% after 1 year and 1.71%
after 3 years (p<0.0001 at both timepoints). The effect of treatment on all outcome
variables was independent of the baseline lung function (prebronchodilator or postbronchodilator)
or baseline medication. In children younger than 11 years, 3-year growth was reduced
in the budesonide group by 1.34 cm. The reduction was greatest in the first year of
treatment (0.58 cm) than years 2 and 3 (0.43 cm and 0.33 cm, respectively).
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.