Long-term safety and efficacy of twice-daily aclidinium bromide in patients with COPD

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• 作者：Arthur F. Gelb ; Donald P. Tashkin ; Barry J. Make ; Xiaoyun Zhong ; Esther Garcia Gil ; Cynthia Caracta ; on behalf of the LAS-MD-35 study investigators
• 关键词：Aclidinium ; Safety ; Bronchodilation ; Health status ; Tolerability ; COPD
• 刊名：Respiratory Medicine
• 出版年：December, 2013
• 年：2013
• 卷：107
• 期：12
• 页码：1957-1965
• 全文大小：867 K

文摘

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Summary

Background

Aclidinium is a novel, long-acting muscarinic antagonist indicated for maintenance treatment of COPD.

Methods

In this 52-week, parallel-group, double-blind study, patients with moderate-to-severe COPD were randomized (1:1) to receive aclidinium twice-daily (BID) 200聽渭g or 400聽渭g via a novel, dry powder inhaler (Genuair^庐/Pressair^庐) [Registered trademarks of Almirall, SA, Barcelona, Spain for use within the European Union, Iceland, Norway, and Switzerland as Genuair^庐 and within the United States as Pressair^庐]. Safety, the primary objective, was assessed via adverse events (AEs), clinical laboratory tests, vital signs, and 12-lead electrocardiograms. Efficacy was evaluated using spirometry, SGRQ, and rescue medication use.

Results

A total of 605 patients were randomized in the study. The percentage of patients reporting any treatment-emergent AE (TEAE) was comparable between groups; most TEAEs were mild or moderate. Anticholinergic TEAEs were reported by low percentages of patients in either treatment group (dry mouth: 200聽渭g, 1.3%; 400聽渭g, 2.7%; constipation: 200聽渭g, 2.9%; 400聽渭g, 1.7%). Cardiac TEAEs were also reported by a low percentage of patients (<2% for any event in any group) and did not appear to be dose dependent. There were no clinically relevant abnormalities in other safety outcomes. Both aclidinium 200聽渭g and 400聽渭g resulted in improvements from baseline to Week 52 in FEV₁, with numerically greater increases observed with the higher dose. Clinically important improvements in SGRQ scores and a reduction in rescue medication use were observed throughout the study for both doses.

Conclusions

Long-term treatment with aclidinium 200聽渭g or 400聽渭g BID was well tolerated, with sustained benefits in lung function and health status in patients with COPD throughout the 1-year study.

Clinical trial registration number

NCT01044459.