The Science Journal of the American Association for Respiratory Care

2006 OPEN FORUM Abstracts

EFFICACY OF NEBULIZED ARFORMOTEROL IN COPD: RESULTS FROM TWO PROSPECTIVE PHASE 3 CLINICAL TRIALS.


JP Hanrahan, MD, MPH;1 SA Sahn, MD;2 CM Fogarty, MD;3 K Sciarappa, PhD;1 RA Baumgartner, MD1

1Sepracor Inc., Marlborough MA; 2Medical University of South Carolina, Charleston SC; 3Spartanburg Pharmaceutical Research, Spartanburg SC

Background: Airway function improvement with arformoterol, a long-acting β2‑agonist that is the (R,R)-isomer of formoterol, and salmeterol were compared with placebo in patients with COPD. Data were pooled from 2 identical multicenter, double-blind, double-dummy, randomized trials.

Methods:
Patients (mean age 63 yrs, 59% male; n=1456 treated) with non-asthmatic COPD (mean FEV1 1.2 L, 40-41% predicted) received either nebulized arformoterol (15 µg BID, 25 µg BID, or 50 µg QD), salmeterol 42 µg BID (via metered dose inhaler), or placebo BID for 12 weeks. The primary efficacy endpoint was the percent (%) change from baseline in morning trough FEV1 (12 hours after the evening dose for the BID groups, 24 hours postdose for the QD group) over 12 weeks. All patients received rescue (albuterol) and supplemental (ipratropium) medications throughout the trial.

Results:
The mean % improvement in morning trough FEV1 over the double-blind period was greater in all arformoterol groups and in the salmeterol group than placebo. After 12 weeks of daily dosing, all active treatments continued to provide greater pulmonary function improvement than placebo.


% Change Trough FEV­1 Placebo (N=293) Arformoterol 15 µg BID (N=278) Arformoterol 25 µg BID (N=284) Arformoterol 50 µg QD (N=281) Salmeterol 42 µg BID (N=276)
Double-Blind Average
Mean (SD) 6.4 (16.2) 17.8 (19.0) 21.8 (21.7) 17.3 (19.7) 18.0 (17.6)
Difference vs. PBO --- 11.4 15.4 10.9 11.6
(95% CI) --- (8.4, 14.3) (12.2, 18.6) (7.9, 13.9) (8.8, 14.4)
Week 12
Mean (SD) 4.7 (20.6) 14.6 (20.9) 17.8 (24.3) 15.3 (24.6) 15.5 (18.6)
Difference vs. PBO --- 9.9 13.1 10.6 10.8
(95% CI) --- (5.9, 14.0) (8.7, 17.5) (6.3, 15.0) (7.0, 14.5)


Improvement in the key secondary efficacy endpoint, the mean 12-hr % change in FEV1 AUC from predose value averaged over 12 weeks, was greater for arformoterol (14.5-19.8%) and salmeterol (10.4%) than for placebo (2.9%). After 12 weeks of treatment, differences for the mean % improvement in this variable persisted for all arformoterol groups (7.5-15.2%) vs. placebo (2.5%), but not for salmeterol (4.3%).


Conclusion: In these Phase 3 trials, arformoterol-treated patients demonstrated significant and sustained improvement in mean airway function over 12 weeks of treatment in comparison with placebo

Support for this study provided by Sepracor Inc.

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