RT Journal Article
SR Electronic
T1 Budesonide/formoterol vs formoterol, both via Turbuhaler®, in patients with moderate to severe COPD: Phase III study results
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP P2108
VO 40
IS Suppl 56
A1 Masakazu Ichinose
A1 Ronnie Samoro
A1 Rustem Fassakhov
A1 Mitsuru Oguri
A1 Jan Ekelund
A1 Lars-Goran Carlsson
A1 Yoshinosuke Fukuchi
YR 2012
UL http://erj.ersjournals.com/content/40/Suppl_56/P2108.abstract
AB Background: This study evaluated the efficacy and tolerability of budesonide/formoterol (BUD/FORM) vs formoterol (FORM) in patients with moderate to severe COPD.Methods: In this randomised, double-blind, parallel-group, phase III study (NCT01069289) patients with moderate to severe COPD for ≥2 years received either BUD/FORM 160/4.5 µg 2 inhalations twice daily via Turbuhaler® or FORM 4.5 µg 2 inhalations twice daily via Turbuhaler® for 12 weeks. Reliever medication: salbutamol 100 μg/actuation via pMDI. Primary outcome variable: change from baseline over the treatment period in predose FEV1; secondary outcome variables included: lung function, time to first exacerbation, tolerability.Results: 1293 patients were randomised. Both BUD/FORM and FORM improved predose FEV1 (improvements of 4.6% and 1.5%, respectively); the change from baseline was significantly greater with BUD/FORM vs FORM (BUD/FORM:FORM ratio: 1.032; 95% CI: 1.013–1.052; p=0.0011). Significantly greater improvements in other lung function measures were also observed. BUD/FORM patients had a statistically significantly prolonged time to first exacerbation vs FORM patients (hazard ratio: 0.679; 95% CI: 0.507–0.909; p=0.0094). Both treatments were well tolerated. The incidence and type of adverse events were similar in both groups; most commonly reported adverse events (BUD/FORM vs FORM): COPD (8.0% vs 9.4%), nasopharyngitis (5.5% vs 4.9%) and bronchitis (2.0% vs 2.3%).Conclusions: BUD/FORM 160/4.5 µg two inhalations twice daily was more effective than FORM 4.5 µg two inhalations twice daily in patients with moderate to severe COPD. Both treatments were well tolerated.Funding: AstraZeneca.