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Comparison of a combination of tiotropium and formoterol to salmeterol and fluticasone in moderate COPD

¹ Department of Pulmonology C3-P, Leiden University Medical Center, Albinusdreef 2 Postbus, NL-2300 Leiden ² Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany

k.f.rabe{at}lumc.nl

Abstract

Background: A six-week, multicentre, randomized, double-blind, parallel group study was conducted in patients with chronic obstructive lung disease (COPD) to compare lung function improvements of tiotropium (Spiriva^®) 18 µg once daily plus formoterol 12 µg b.i.d. to salmeterol 50 µg b.i.d. plus fluticasone 500 µg b.i.d.

Methods: Following a screening visit, subjects entered a run-in period in which they received regular ipratropium (Atrovent^â). At randomisation, patients were assigned to either tiotropium plus formoterol or salmeterol plus fluticasone. After six weeks of treatment, a 12-hour lung function profile was obtained. The co-primary endpoints were FEV₁ area under the curve for the time period 0 to 12 hours (FEV₁ AUC_0-12) and peak FEV₁.

Results: 729 patients were screened, 605 were randomised and treated. 592 patients (baseline FEV₁ (±SD): 1.32 L (±0.43 L)) were included in the analysis. After six weeks, the 12-hour lung function profiles in the group receiving tiotropium plus formoterol were superior to the salmeterol plus fluticasone group (mean difference in FEV₁ AUC_0-12h 78 mL, p=0.0006; difference in FVC AUC_0-12h 173 mL, p<0.0001). Also, peak responses were in favour of tiotropium plus formoterol (difference in peak FEV₁ 103 mL, p<0.0001; difference in peak FVC 214 mL, p<0.0001), as were FEV₁ and FVC at each individual time-point post-dose (p<0.05). Pre-dose FVC was significantly higher with the bronchodilator combination, while pre-dose FEV1 and rescue medication use did not differ significantly between groups. Both treatments were well tolerated.

Conclusions: Tiotropium plus formoterol were superior in lung function over the day compared to salmeterol plus fluticasone in patients with moderate COPD. Long-term studies in severe COPD are warranted to assess the relative efficacy of different treatment combinations. (NCT00239421 [ClinicalTrials.gov] ).

Key Words: COPD • lung function • tiotropium • formoterol • salmeterol • fluticasone • combination treatment