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Obstructive Lung Diseases |

Effects of Aclidinium Bromide in Patients With Chronic Obstructive Pulmonary Disease: Clinically Significant Improvements in Health Status in Two 1-Year Studies

Arthur Gelb*, MD; Anthony D'Urzo, MD; Donald Tashkin, MD; Xiaoyun Zhong, PhD; Esther Garcia Gil, MD; Cynthia Caracta, MD
Author and Funding Information

Southern California Clinical Trials, Lakewood, CA


Chest. 2012;142(4_MeetingAbstracts):691A. doi:10.1378/chest.1389776
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Abstract

SESSION TYPE: COPD: Safety and Effectiveness of Newer Therapies

PRESENTED ON: Tuesday, October 23, 2012 at 02:45 PM - 04:15 PM

PURPOSE: Aclidinium is a long-acting muscarinic antagonist under investigation for the maintenance treatment of COPD. The effect of twice-daily (BID) aclidinium on health outcomes in moderate-to-severe COPD patients was assessed in 2 double-blind, Phase 3 trials (LAS-MD-35 and -36).

METHODS: In LAS-MD-35, patients (N=605) were randomized (1:1) to aclidinium 200 or 400 µg BID for 52 weeks. LAS-MD-36 (N=291) was a 52-week extension of the 12-week ACCORD COPD I study. Here patients on placebo during lead-in were re-randomized (1:1) to aclidinium 200 or 400 µg BID, and patients on aclidinium 200 or 400 µg BID during lead-in continued the same treatment. Health status was assessed via SGRQ at Weeks 12, 24, 36, 48, and 52. Rescue medication use was also evaluated.

RESULTS: In LAS-MD-35, patients on both doses of aclidinium showed mean improvements from baseline in SGRQ total score ranging from 5.2 to 6.6 units at every study visit with improvements of 5.3 (200 μg) and 5.2 units (400 μg) at study end. At Week 52, 43% and 45% of patients on aclidinium 200 and 400 µg, respectively, achieved clinically significant improvements in SGRQ total score (≥4-unit improvement from baseline). In LAS-MD-36, patients re-randomized from placebo to aclidinium 200 or 400 µg demonstrated mean improvements from baseline (Visit 2 of lead-in) in SGRQ total score ranging from 4.2 to 6.4 units at every study visit, with improvements at study end of 4.9 (200 µg) and 5.7 units (400 µg). For patients who were switched to aclidinium 200 or 400 µg, 43% and 59%, respectively, achieved clinically significant improvements from baseline in SGRQ total score at study end. Patients on continuous aclidinium maintained improvements from baseline in SGRQ total score ranging from 6.2 to 8.1 units for both doses at all study visits; improvements of 7.0 (200 µg) and 7.9 (400 µg) were seen at study end. After 64 weeks of continuous treatment (Week 52), 51% and 64% of patients on aclidinium 200 and 400 µg, respectively, achieved clinically significant improvements from baseline in SGRQ total score. Aclidinium reduced total daily rescue medication use in both studies by 1.5 to 2.6 puffs for 200 μg and by 1.4 to 2.7 puffs for 400 μg.

CONCLUSIONS: In these long-term studies, aclidinium 200 and 400 µg provided clinically significant improvements in health status and reduced rescue medication use in COPD patients.

CLINICAL IMPLICATIONS: Results from these studies indicate that aclidinium improves patients’ health status and could be a valuable new treatment option for COPD.

DISCLOSURE: Arthur Gelb: Consultant fee, speaker bureau, advisory committee, etc.: Consultant

Anthony D'Urzo: Consultant fee, speaker bureau, advisory committee, etc.: Consultant

Donald Tashkin: Consultant fee, speaker bureau, advisory committee, etc.: Consultant, Grant monies (from industry related sources): Forest Research Institute

Xiaoyun Zhong: 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.

Southern California Clinical Trials, Lakewood, CA

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