SESSION TYPE: COPD: Therapeutic Options
PRESENTED ON: Sunday, October 21, 2012 at 10:30 AM - 11:45 AM
PURPOSE: Aclidinium is a novel, long-acting muscarinic antagonist currently under investigation for the maintenance treatment of COPD. The long-term effects of twice-daily (BID) aclidinium on lung function in moderate-to-severe COPD patients were assessed in this study.
METHODS: In this 52-week extension of the 12-week ACCORD I study, patients receiving placebo during lead-in were re-randomized (1:1) to aclidinium 200 µg (n=44) or 400 µg (n=46) BID, and patients receiving aclidinium 200 µg or 400 µg BID during lead-in continued the same treatment (n=95 and n=106, respectively). Lung function was assessed using morning predose (trough) forced expiratory volume in 1 second (FEV1) and peak FEV1 at Day 1 of the lead-in (peak FEV1 only) and at Weeks 12 (24), 24 (36), and 52 (64) from extension (lead-in) study start.
RESULTS: Of the 467 patients who completed the lead-in, 291 enrolled in the extension study. Patients on continuous aclidinium started the extension study with mean improvements from baseline (Visit 2 of lead-in) in trough FEV1 of 87 mL (200 µg) and 137 mL (400 µg). Improvements from baseline in trough FEV1 were maintained throughout the study for 200 μg (range 62-127 mL) and 400 μg (range 56-140 mL). Peak FEV1 improvements observed from the first dose of aclidinium (Day 1 of lead-in, 200 μg, 235 mL; 400 μg, 265 mL) were maintained to Week 52 (Week 64 of treatment, 200 µg, 213 mL; 400 µg, 219 mL). Patients re-randomized from placebo to aclidinium 200 µg and 400 µg started the extension study with mean worsening from baseline in trough FEV1 of -60 mL and -18 mL, respectively. Following 12 weeks of aclidinium treatment in the extension study, patients’ lung function went from a worsened state to a mean improvement in change from baseline (Visit 2 of lead-in) in trough FEV1 of 44 mL (200 µg) and 109 mL (400 µg). These changes were maintained to study end with aclidinium 400 µg. Improvements from baseline in peak FEV1 seen at Week 12 of the extension study were also maintained to study end (200 µg, 111 mL; 400 µg, 222 mL).
CONCLUSIONS: Continuous aclidinium 200 µg and 400 µg BID resulted in improvements in lung function on the first day of treatment that were maintained up to 64 weeks. Patients re-randomized to aclidinium 400 μg BID also maintained similar improvements in lung function for 52 weeks.
CLINICAL IMPLICATIONS: These results demonstrate that aclidinium provides maximal bronchodilation after the first dose that is sustained over 52 weeks. Aclidinium may be a valuable new treatment option for COPD.
DISCLOSURE: Anthony D'Urzo: Consultant fee, speaker bureau, advisory committee, etc.: Consultant
Edward Kerwin: Consultant fee, speaker bureau, advisory committee, etc.: Consultant
Stephen Rennard: Consultant fee, speaker bureau, advisory committee, etc.: Consultant
Thomas He: Employee: Employee of Forest Research Institute
Esther Garcia Gil: Employee: Employee of Almirall S.A.
Cynthia Caracta: Employee: Employee of Forest Research Institute
Aclidinium is currently under FDA review for the treatment of COPD.University of Toronto, Toronto, ON, Canada