Efficacy Safety Study of Arformoterol QD Dosing Versus BID Dosing in COPD

Summary

To evaluate the efficacy and safety of arformoterol tartrate inhalation solution 30μg/4mL QD (two 15μg/2mL dosed in combination) over a 24-hour period compared to arformoterol tartrate inhalation solution 15μg/2 mL BID in subjects with COPD.

Timeline

Start

2007-11

Primary completion

2008-03

Completion

2008-03

Outcome

Met primary endpoint

paper The 90% CI for FEV(1)AUC(0-24) for the treatment difference between ARF15 BID and ARF30 QD was within the prespecified range of -0.07 to 0.07 L. PMID 19808130 ↗

Publications

• Panettieri RA Jr, MacIntyre N, Sims M, Kerwin E, Fogarty C, Noonan M, Claus R, Andrews WT. Comparison of the efficacy and safety of arformoterol 15 microg twice daily and arformoterol 30 microg once daily in COPD: a single-dose, multicenter, randomized, modified-blind, two-way crossover study. Clin Ther. 2009 Aug;31(8):1716-23. doi: 10.1016/j.clinthera.2009.08.012.

Drugs

Indications