Budesonide/formoterol via Turbuhaler® versus formoterol via Turbuhaler® in patients with moderate to severe chronic obstructive pulmonary disease: Phase III multinational study results. Issue 5 (21st June 2013)

• Record Type: Journal Article
• Authors: Fukuchi, Yoshinosuke; Samoro, Ronnie; Fassakhov, Rustem; Taniguchi, Hiroyuki; Ekelund, Jan; Carlsson, Lars‐Goran; Ichinose, Masakazu
• Is Part Of: Respirology. Volume 18:Issue 5(2013)
• Page Start: 866
• Page End: 873
• Publication Date: 2013-06-21
• Subjects: Respiratory organs -- Diseases -- Periodicals; Respiratory organs -- Periodicals; 612.2
• DOI: 10.1111/resp.12090
• Languages: English
• ISSNs: 1323-7799

Abstract

<abstract abstract-type="main"> <title>Abstract</title> <sec id="resp12090-sec-0001" sec-type="section"> <title>Background and objective</title> <p>The efficacy and tolerability of budesonide/formoterol versus formoterol in patients with moderate to severe chronic obstructive pulmonary disease (COPD) was evaluated.</p> </sec> <sec id="resp12090-sec-0002" sec-type="section"> <title>Methods</title> <p>In this randomized, double‐blind, parallel‐group, phase III study (NCT01069289), patients with moderate to severe COPD for ≥2 years received either budesonide/formoterol 160/4.5 μg two inhalations twice daily via Turbuhaler® or formoterol 4.5 μg two inhalations twice daily via Turbuhaler® for 12 weeks. Salbutamol was available as reliever medication. Primary outcome variable: change from baseline to average during treatment in pre‐dose forced expiratory volume in 1 s (FEV<sub>1</sub>).</p> </sec> <sec id="resp12090-sec-0003" sec-type="section"> <title>Results</title> <p>One thousand two hundred ninety‐three patients were randomized (budesonide/formoterol <italic>n</italic> = 636; formoterol <italic>n</italic> = 657). Both budesonide/formoterol and formoterol increased pre‐dose FEV<sub>1</sub> versus baseline (improvements of 4.6% and 1.5% over baseline, respectively), with the increase from baseline being significantly greater with budesonide/formoterol versus formoterol (budesonide/formoterol:formoterol ratio 1.032; 95% confidence interval: 1.013–1.052; <italic>P</italic> = 0.0011). The budesonide/formoterol group had a significantly prolonged time to first exacerbation versus the formoterol group (hazard ratio: 0.679; 95% confidence interval: 0.507–0.909; <italic>P</italic> = 0.0094) and significantly greater improvements in many secondary outcome measures. Both treatments were well tolerated; the incidence and type of adverse events were similar: most commonly reported (budesonide/formoterol vs formoterol): COPD (8.0% vs 9.4%) and nasopharyngitis (5.5% vs 4.9%).</p> </sec> <sec id="resp12090-sec-0004" sec-type="section"> <title>Conclusions</title> <p>Budesonide/formoterol 160/4.5 μg two inhalations twice daily was effective and well tolerated in patients with moderate to severe COPD, offering benefits over formoterol alone in terms of improved lung function and reduced risk of exacerbation.</p> </sec> </abstract>