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Maintenance plus as needed budesonide plus formoterol was better than fixed dose for severe exacerbations in asthma

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 Q In patients with asthma, is budesonide (BUD) plus formoterol (FORM) (BUD+FORM) both for maintenance and symptom relief more effective than fixed dosing using BUD+FORM plus a short acting β2 agonist (SABA) or a 4 fold higher dose of BUD plus SABA for reducing the rate of severe asthma exacerbations?

Clinical impact ratings GP/FP/Primary care ★★★★★☆☆ Internal medicine ★★★★★★☆ Respirology ★★★★★★★

METHODS

Embedded ImageDesign:

randomised controlled trial.

Embedded ImageAllocation:

concealed.*

Embedded ImageBlinding:

blinded (patients and healthcare providers).*

Embedded ImageFollow up period:

1 year.

Embedded ImageSetting:

246 centers in 22 countries

Embedded ImagePatients:

2760 outpatients 4–80 years of age (mean age 36 y, 55% female; 12% children 4–11 y of age) with asthma who were using inhaled corticosteroids.

Embedded ImageIntervention:

BUD+FORM (budesonide, 80 μg, plus formoterol, 4.5 μg) both for maintenance and as needed (BUD+FORM for both, n = 925), BUD+FORM for maintenance plus terbutaline, 0.4 …

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Footnotes

  • * See glossary.

  • For correspondence: Dr P M O’Byrne, St Joseph’s Hospital, Hamilton, Ontario, Canada. obyrnepmcmaster.ca

  • Source of funding: AstraZeneca R&D, Lund, Sweden.