Document Type
Article
Journal Title
Respiratory Research
Publication Date
2011
Volume
12
Abstract
BACKGROUND: The long-term efficacy and safety of aclidinium bromide, a novel, long-acting muscarinic antagonist, were investigated in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
METHODS: In two double-blind, 52-week studies, ACCLAIM/COPD I (n=843) and II (n=804), patients were randomised to inhaled aclidinium 200 μg or placebo once-daily. Patients were required to have a post-bronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity ratio of ≤70% and FEV1< 80% of the predicted value. The primary endpoint was trough FEV1 at 12 and 28 weeks. Secondary endpoints were health status measured by St George's Respiratory Questionnaire (SGRQ) and time to first moderate or severe COPD exacerbation.
RESULTS: At 12 and 28 weeks, aclidinium improved trough FEV1 versus placebo in ACCLAIM/COPD I (by 61 and 67 mL; both p< 0.001) and ACCLAIM/COPD II (by 63 and 59 mL; both p< 0.001). More patients had a SGRQ improvement≥4 units at 52 weeks with aclidinium versus placebo in ACCLAIM/COPD I (48.1% versus 39.5%; p=0.025) and ACCLAIM/COPD II (39.0% versus 32.8%; p=0.074). The time to first exacerbation was significantly delayed by aclidinium in ACCLAIM/COPD II (hazard ratio [HR] 0.7; 95% confidence interval [CI] 0.55 to 0.92; p=0.01), but not ACCLAIM/COPD I (HR 1.0; 95% CI 0.72 to 1.33; p=0.9). Adverse events were minor in both studies.
CONCLUSION: Aclidinium is effective and well tolerated in patients with moderate to severe COPD.
TRIAL REGISTRATION: ClinicalTrials.gov: NCT00363896 (ACCLAIM/COPD I) and NCT00358436 (ACCLAIM/COPD II).
MeSH Headings
Administration, Inhalation, Aged, Bronchodilator Agents, Double-Blind Method, Drug Administration Schedule, Dry Powder Inhalers, Dyspnea, Europe, Female, Forced Expiratory Volume, Health Status, Humans, Logistic Models, Lung, Male, Middle Aged, Muscarinic Antagonists, North America, Pulmonary Disease, Chronic Obstructive, Quality of Life, Severity of Illness Index, Surveys and Questionnaires, Time Factors, Treatment Outcome, Tropanes
DOI Link
ISSN
1465-993X
Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.
Recommended Citation
Jones, Paul W.; Rennard, Stephen I.; Agusti, Alvar; Chanez, Pascal; Magnussen, Helgo; Fabbri, Leonardo; Donohue, James F.; Bateman, Eric D.; Gross, Nicholas J.; Lamarca, Rosa; Caracta, Cynthia; and Gil, Esther Garcia, "Efficacy and Safety of Once-Daily Aclidinium in Chronic Obstructive Pulmonary Disease" (2011). Journal Articles: Pulmonary & Critical Care Med. 75.
https://digitalcommons.unmc.edu/com_pulm_articles/75
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