PURPOSE: The impact of treatment with the long-term acting β2-agonists (LABAs) arformoterol (administered via nebulization) and racemic formoterol dry powder inhaler (DPI) on symptom and functioning outcomes in 443 subjects with COPD was evaluated.
METHODS: COPD subjects (mean FEV1 1.21 L, ∼41.0 % predicted) were randomized to receive nebulized arformoterol (15μg BID [n=149] or 25μg BID [n=147]) or formoterol 12μg BID [n=147]) for 6-months in a multi-center, double-blind, randomized trial. The effect of treatment on dyspnea (Baseline Dyspnea Index [BDI]/Transition Dyspnea Index [TDI]), and patient clinical status (St. George Respiratory Questionnaire [SGRQ], and BODE scores) were evaluated.
RESULTS: Mean (±SD) BDI was not different between treatment groups (ranged 5.1±2.4 to 5.3±2.2). Mean (±SD) TDI focal score improved significantly but similarly for all treatment groups at 13 weeks (range 1.5±2.6 to 1.6±2.7) and at 6-months (range: 1.4±2.8 to 1.5±2.8). At the end of 6-months, 48.0% to 52.4% of subjects had ≥1 unit improvement in TDI. Mean (±SD) baseline SGRQ total score was also similar for all treatment groups (range: 48.9±14.9 to 52.4±17.7). Mean (±SD) SGRQ total score improved significantly from baseline for the three treatment groups, both at 13-weeks (range: −1.9±9.9 to −4.2±10.1) and at 6-months (range: −3.7±11.8 to −6.8±10.1). At 6-months, 43.3% to 56.7% of subjects improved by ≥4 units. BODE scores were similar at baseline among treatment groups (Mean ± SD range: 4.8±1.6 to 5.1±1.7), and improved significantly but similarly from baseline for all treatment groups at 13 weeks (range: −0.6±1.5 to −0.9±1.3) and 6-months (range: −0.8±1.5 to −1.1±1.5).
CONCLUSION: In this study, 6-month maintenance LABA treatment (nebulized arformoterol or formoterol DPI) of subjects with COPD was associated with improvement in TDI, SRGQ, and BODE indexes over 6-months.
CLINICAL IMPLICATIONS: Long-term maintenance use of the LABAs arformoterol and formoterol improves dyspnea, measures of health status and functioning in COPD subjects.Support for this study provided by Sepracor Inc.
DISCLOSURE: Frank Sciurba, No Financial Disclosure Information; No Product/Research Disclosure Information