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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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Therapeutics
Low dose budesonide improved asthma control in mild asthma; adding formoterol improved control in corticosteroid treated patients

https://doi.org/10.1136/ebm.7.4.120

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    (2001) Am J Respir Crit Care Med 164, 1392; O’Byrne PM, Barnes PJ, Rodriguez-Roisin R, et al.. Low dose inhaled budesonide and formoterol in mild persistent asthma: the OPTIMA randomized trial.. Oct 15;. :. –7.
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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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    Footnotes

    • Source of funding: AstraZeneca, Lund, Sweden.

    • For correspondence: Dr P M O’Byrne, St. Joseph’s Healthcare, Hamilton, Ontario, Canada. obyrnep{at}mcmaster.ca.

    • ↵* See glossary.

    • ↵† Information provided by author.