ACCORD COPD II: a randomized clinical trial to evaluate the 12-week efficacy and safety of twice-daily aclidinium bromide in chronic obstructive pulmonary disease patients.

Abstract

BACKGROUND AND OBJECTIVES:

Aclidinium bromide is a long-acting muscarinic antagonist approved for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD). This 12-week phase III study evaluated efficacy and tolerability of aclidinium 200 or 400 μg in patients with moderate-to-severe COPD.

METHODS:

In this double-blind study, 544 patients with COPD were randomized to placebo or twice-daily aclidinium 200 or 400 μg administered by Genuair(®)/Pressair(®). Lung function, health status [measured by the St. George's Respiratory Questionnaire (SGRQ)], dyspnea [measured using the Transition Dyspnea Index (TDI)], and safety were assessed throughout the study.

RESULTS:

Mean changes from baseline in morning trough forced expiratory volume in 1 s (FEV(1)) at week 12 (primary endpoint) were significantly higher for aclidinium than for placebo (200 μg, 51 mL; 400 μg, 72 mL; both p < 0.05). Aclidinium also significantly improved other lung function outcomes. At week 12, improvements from baseline were observed with aclidinium in SGRQ total score (200 μg, -6.0; 400 μg, -5.4) and TDI focal score (200 μg, 1.0; 400 μg, 1.3). Furthermore, clinically important improvements in SGRQ total and TDI focal scores were achieved by 45 and 51 % of patients, respectively, who received aclidinium 400 μg, with a significant difference versus placebo for TDI (p < 0.05). Anticholinergic-related adverse events (e.g., dry mouth) were infrequent, occurring <2 % for any event in any treatment group. Both aclidinium doses were well tolerated.

CONCLUSION:

This study demonstrates efficacy and safety of aclidinium in COPD patients. Unexpected baseline imbalances between treatment groups may have impacted the aclidinium treatment benefit in this study.

• Authors: Stephen I Rennard, Paul D Scanlon, Gary T Ferguson, Ludmyla Rekeda, Brian T Maurer, Esther Garcia Gil, Cynthia F Caracta
• Journal: Clinical drug investigation (Clin Drug Investig) Vol. 33 Issue 12 Pg. 893-904 (Dec 2013) ISSN: 1179-1918 [Electronic] New Zealand
• PMID: 24085591 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Muscarinic Antagonists
• Placebos
• Tropanes
• aclidinium bromide

Topics

• Aged
• Drug Administration Schedule
• Female
• Humans
• Male
• Middle Aged
• Muscarinic Antagonists (administration & dosage, adverse effects, therapeutic use)
• Placebos
• Pulmonary Disease, Chronic Obstructive (drug therapy, physiopathology)
• Respiratory Function Tests
• Tropanes (administration & dosage, adverse effects, therapeutic use)