RT Journal Article
SR Electronic
T1 Pooled analysis of twice-daily aclidinium bromide in COPD patients: Dyspnea and health status in the ACCORD-COPD I and ATTAIN trials
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP P2891
VO 40
IS Suppl 56
A1 Paul Jones
A1 Edward Kerwin
A1 Eric Bateman
A1 Rosa Lamarca
A1 Cynthia Caracta
A1 Esther Garcia Gil
YR 2012
UL http://erj.ersjournals.com/content/40/Suppl_56/P2891.abstract
AB INTRODUCTION:Aclidinium is a novel, long-acting muscarinic antagonist in development for COPD treatment. Pooled analyses of dyspnea and health status data are shown here.METHODS:Patients (N=1389) were randomized (1:1:1) to aclidinium 200 μg, 400 μg or pbo BID for 12- and 24-weeks for the ACCORD and ATTAIN trials, respectively. Endpoints for both studies included TDI focal score, SGRQ total score and rescue medication use.RESULTS:The 200 μg and 400 μg groups showed statistically significant improvements from baseline to Week 12 in TDI focal score vs pbo (200 μg, 0.58, p<0.01; 400 μg, 0.92, p<0.0001), with numerically greater improvements seen with the higher dose. Clinically significant improvements (≥1-unit increase) in TDI at Week 12 were seen in a significantly higher proportion of patients in the 200 μg (51.3%, p=0.0001) and 400 μg (54.8%, p<0.0001) groups vs pbo (38.8%). Both doses resulted in statistically significant improvements from baseline to Week 12 in SGRQ total score vs pbo (200 μg, -5.10; 400 μg, -5.51, both p<0.0001). Clinically significant improvements (≥4-unit decrease) in SGRQ total score were seen in a significantly higher percentage of patients in the 200 μg (51.0%) and 400 μg (51.8%) groups (both p<0.001) vs pbo (38.1%) at Week 12. Both doses of aclidinium resulted in a significant reduction over pbo in daily rescue medication use (-0.6 puffs, 200 µg; -0.9 puffs, 400 µg; both p<0.005).CONCLUSIONS:Aclidinium 200 μg and 400 μg BID resulted in significantly more COPD patients who experienced clinically meaningful benefits in dyspnea and health status (>12% more in every case) as well as less rescue medication use versus placebo.