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Effect of budesonide/formoterol pMDI on COPD exacerbations: A double-blind, randomized study
Respiratory Medicine, 12/27/2011
Clinical Article
Sharafkhaneh A et al. - Over 12 months, both budesonide/formoterol doses reduced the exacerbation rate (defined with or without antibiotic treatment) versus formoterol. Budesonide/formoterol pressurized metered-dose inhaler (pMDI) is an appropriate treatment for reducing exacerbations in chronic obstructive pulmonary disease (COPD) patients with a history of exacerbations.
Methods- Following a 2-week run-in during which COPD patients aged ≥40 years with an exacerbation history discontinued medications except ICSs, 1219 patients were randomized 1:1:1 to twice-daily budesonide/formoterol pMDI 320/9 μg, budesonide/formoterol pMDI 160/9 μg, or formoterol dry powder inhaler 9 μg.
- An exacerbation was defined as COPD worsening requiring oral corticosteroids and/or hospitalization.
- A post hoc analysis, with antibiotic treatment added to the exacerbation definition, was also performed.
- Budesonide/formoterol 320/9 and 160/9 reduced exacerbation rates (number per patient-treatment year) by 34.6% and 25.9%, respectively, versus formoterol (p ≤ 0.002).
- Budesonide/formoterol 320/9 prolonged time to first exacerbation versus formoterol, corresponding to a 21.2% reduction in hazard ratio (0.788 [95% CI: 0.639, 0.972]; p = 0.026).
- Exacerbation rates (number per patient-treatment year) including antibiotic treatment (post hoc analysis) were reduced by 25.9% and 18.7% with budesonide/formoterol 320/9 and 160/9, respectively, versus formoterol (p ≤ 0.023).
- Both budesonide/formoterol doses were well tolerated with safety profiles similar to formoterol.
- Pneumonia adverse events occurred in 6.4%, 4.7%, and 2.7% of patients in the budesonide/formoterol 320/9, 160/9, and formoterol groups.