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Evidence-Based Medicine 2006;11:138; doi:10.1136/ebm.11.5.138
Copyright © 2006 by the BMJ Publishing Group Ltd.

Therapeutics

Combined budesonide and formoterol for maintenance and relief provided better asthma control than budesonide for maintenance and terbutaline for relief

Rabe KF, Pizzichini E, Ställberg B, et al. Budesonide/formoterol in a single inhaler for maintenance and relief in mild-to-moderate asthma: a randomized, double-blind trial. Chest 2006;129:246–56.[Abstract/Free Full Text]

Q In patients with mild to moderate asthma, what is the efficacy and safety of budesonide plus formoterol in a single inhaler for both maintenance therapy and symptom relief compared with budesonide for maintenance therapy plus terbutaline for symptom relief?

Clinical impact ratings GP/FP/Primary care ******{star} Allergy & immunology ******* Respirology *****{star}{star}

Key Words: asthma • bronchodilator agents • budesonide • ethanolamines

The first 150 words of the full text of this article appear below.

METHODS

Formula Design: randomised controlled trial.

Formula Allocation: concealed (unclear).*

Formula Blinding: blinded (patients).*

Formula Follow up period: 6 months.

Formula Setting: 77 centres in Argentina, Brazil, China, Denmark, Indonesia, Norway, the Philippines, Spain, and Sweden.

Formula Patients: 697 patients 11–79 years of age (mean age 38 y, 61% women) with asthma for >=6 months. Exclusion criteria included systemic corticosteroids or inhaled cromones in the past 30 days, recent respiratory infection, smoking history >10 pack years, and failure to complete a run in period as planned.

Formula Intervention: budesonide/formoterol, 80 µg/4.5 µg, 2 inhalations every evening plus budesonide/formoterol as needed (n = 355) or budesonide, 160 µg, 2 inhalations every evening plus terbutaline, 0.4 mg as needed (n = 342). As needed inhalations were limited to <=10/day.

Formula Outcomes: change from baseline in morning peak expiratory flow (PEF). Secondary outcomes were evening PEF, severe exacerbations, asthma symptom control, and adverse events.

Formula Patient follow up: 639 patients (92%) (1 patient . . . [Full text of this article]

Bernard Adelsberg, MD

CT Medical Group, New Haven, Connecticut, USA


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Evid. Based Med. 2006 11: 159a. (in Glossary) [Extract] [Full Text] [PDF]

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