Budesonide/formoterol as effective as prednisolone plus formoterol in acute exacerbations of COPD: a double-blind, randomised, non-inferiority, parallel-group, multicentre study
Oral corticosteroids and inhaled bronchodilators with or without antibiotics represent standard treatment of COPD exacerbations. Frequent courses of oral steroids may be a safety issue.
We wanted to evaluate in an out-patient setting whether a 2-week course of inhaled budesonide/formoterol would be equally effective for treatment of acute COPD exacerbations as standard therapy in patients judged by the investigator not to require immediate hospitalisation.
Methods: This was a double-blind, randomised, non-inferiority, parallel-group, multicentre study comparingtwo treatment strategies; two weeks' treatment with inhaled budesonide/formoterol (320/9 ug, qid) was compared with prednisolone (30 mg once daily) plus inhaled formoterol (9ug bid) in patients with acute exacerbations of COPD attending a primary healthcare centre. Inclusion criteria were progressive dyspnoea for less than one week, FEV1 30-60% of predicted normal and no requirement for immediate hospitalisation.A total of 109 patients (mean age 67 years, 33 pack-years, mean FEV1 45% of predicted) received a single dose of oral corticosteroid plus nebulised salbutamol/ipratropium bromide followed by two weeks' double-blind treatment (budesonide/formoterol or prednisolone plus formoterol) and subsequent open-label budesonide/formoterol (320/9 ug bid) for another 12 weeks.
Change in FEV1 was the primary efficacy variable. Non-inferiority was predefined.
Results: Non-inferiority of budesonide/formoterol was proven because the lower limit of FEV1-change (97.5% CI) was above 90% of the efficacy of the alternative treatment.
Symptoms, quality of life, treatment failures, need for reliever medication (and exacerbations during follow-up) did not differ between the groups. No safety concerns were identified.
Conclusions: Budesonide/formoterol was as effective as prednisolone plus formoterol for the treatment of acute exacerbations in COPD and may be an alternative for patients not immediately requiring hospitalisation.
Author: Bjorn Stallberg, Olof Selroos, Claus Vogelmeier, Eva Andersson, Tommy Ekstrom and Kjell Larsson
Credits/Source: Respiratory Research 2009, 10:11
Published on: 2009-02-19
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