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

Abstract

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 FEV(1) 1.37L, 45.4% predicted) were randomized to receive mono-therapy (either arformoterol 15microg BID [n=76] or tiotropium 18microg QD [n=80]), or combined therapy (sequential dosing of arformoterol 15microg BID and tiotropium 18microg QD [n=78]). Changes in pulmonary function, dyspnea, and rescue levalbuterol use were evaluated, as were safety outcomes.

RESULTS:

Mean FEV(1)AUC(0-24) (the primary endpoint) improved similarly from baseline for arformoterol (0.10L) and tiotropium (0.08L) treatment groups and greater for the combined therapy group (0.22L; all p-values <0.005). Peak FEV(1), peak FVC, 24-h trough FEV(1), 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 15microg BID plus tiotropium 18microg 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.

• Authors: D P Tashkin, J F Donohue, D A Mahler, H Huang, E Goodwin, K Schaefer, J P Hanrahan, W T Andrews
• Journal: Respiratory medicine (Respir Med) Vol. 103 Issue 4 Pg. 516-24 (Apr 2009) ISSN: 1532-3064 [Electronic] England
• PMID: 19208459 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Bronchodilator Agents
• Ethanolamines
• Scopolamine Derivatives
• Albuterol
• Formoterol Fumarate
• Tiotropium Bromide

Topics

• Administration, Inhalation
• Aged
• Albuterol (administration & dosage)
• Bronchodilator Agents (administration & dosage)
• Double-Blind Method
• Drug Administration Schedule
• Drug Therapy, Combination
• Dyspnea (drug therapy)
• Ethanolamines (administration & dosage)
• Female
• Forced Expiratory Volume
• Formoterol Fumarate
• Humans
• Male
• Middle Aged
• Prospective Studies
• Pulmonary Disease, Chronic Obstructive (drug therapy)
• Scopolamine Derivatives (administration & dosage)
• Tiotropium Bromide
• Treatment Outcome
• Vital Capacity