Elsevier

Respiratory Medicine

Volume 103, Issue 4, April 2009, Pages 516-524
Respiratory Medicine

Effects of arformoterol twice daily, tiotropium once daily, and their combination in patients with COPD

https://doi.org/10.1016/j.rmed.2008.12.014Get rights and content
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Summary

Purpose

Current guidelines support using in combination more than one class of long-acting bronchodilator for COPD patients whose symptoms are not controlled by mono-therapy. This 2-week, multi-center (34 sites), randomized, modified-blind, parallel group study evaluated the efficacy and safety of concomitant treatment with nebulized arformoterol (the formoterol(R,R)-isomer) BID and tiotropium DPI QD.

Methods

COPD patients (mean FEV1 1.37 L, 45.4% predicted) were randomized to receive mono-therapy (either arformoterol 15 μg BID [n = 76] or tiotropium 18 μg QD [n = 80]), or combined therapy (sequential dosing of arformoterol 15 μg BID and tiotropium 18 μg QD [n = 78]). Changes in pulmonary function, dyspnea, and rescue levalbuterol use were evaluated, as were safety outcomes.

Results

Mean FEV1AUC0–24 (the primary endpoint) improved similarly from baseline for arformoterol (0.10 L) and tiotropium (0.08 L) treatment groups and greater for the combined therapy group (0.22 L; all p-values <0.005). Peak FEV1, peak FVC, 24-h trough FEV1, and inspiratory capacity also improved similarly for the mono-therapies and greatest for the combined therapy. Dyspnea (mean transition dyspnea index) improved similarly for arformoterol (+2.3) and tiotropium (+1.8) and greatest with combined therapy (+3.1; p-values <0.05). Levalbuterol use decreased for all treatment groups (range −1.8 to −2.5 actuations/day). All treatments had similar frequency of adverse events.

Conclusion

In this study, the combination of nebulized arformoterol 15 μg BID plus tiotropium 18 μg DPI QD was the most effective in improving pulmonary function and disease symptoms. Mono-therapy improvement with arformoterol or tiotropium was similar. All three treatments were well tolerated.

Keywords

Arformoterol
Tiotropium
COPD
Pulmonary function

Cited by (0)

Clinical Trials Registry no. NCT00424528 (data has been submitted; not yet posted).

e

Current address: Pulmatrix Inc., Lexington, MA, USA.

f

Current address: Santhera Pharamaceuticals, Cambridge, MA, USA.