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Low dose budesonide improved asthma control in mild asthma; adding formoterol improved control in corticosteroid treated patients
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 QUESTION: In patients with mild asthma, do regular low doses of inhaled budesonide, with or without low doses of inhaled formoterol, reduce severe exacerbations and improve asthma control?

Design

Randomised {allocation concealed*}, blinded {patients, clinicians, data collectors, outcome assessors, data analysts, and monitoring committee},* placebo controlled trial with 1 year of follow up.

Setting

198 centres in 17 countries.

Patients

1970 patients who were ≥ 12 years of age and had mild asthma. 698 corticosteroid free patients (group A) (mean age 31 y, 60% women) had not used an inhaled corticosteroid for ≥ 3 months and had an FEV1 ≥ 80% of predicted normal after inhaling terbutaline, 1 mg. 1272 corticosteroid treated patients (group B) (mean age 37 y, 57% women) were receiving ≤ 400 μg/day of inhaled budesonide or the equivalent for ≥ 3 months, with an FEV1 ≥ 70% of predicted normal after terbutaline. Data from 1947 patients (99%) were included in the analysis.

Intervention

During a 4 week run-in period, group A patients …

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