Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease

Paul W. Jones, Stephen I. Rennard, Alvar Agusti, Pascal Chanez, Helgo Magnussen, Leonardo Fabbri, James F. Donohue, Eric D. Bateman, Nicholas J. Gross, Rosa Lamarca, Cynthia Caracta, Esther G. Gil

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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).

Original languageEnglish (US)
Article number55
JournalRespiratory Research
Volume12
DOIs
StatePublished - Apr 26 2011

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Chronic Obstructive Pulmonary Disease
Safety
Forced Expiratory Volume
Placebos
Confidence Intervals
Muscarinic Antagonists
Bronchodilator Agents
Vital Capacity
Health Status
Disease Progression

Keywords

  • Aclidinium bromide
  • Anticholinergic
  • Chronic obstructive pulmonary disease
  • Long-acting muscarinic antagonist

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

Cite this

Jones, P. W., Rennard, S. I., Agusti, A., Chanez, P., Magnussen, H., Fabbri, L., ... Gil, E. G. (2011). Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease. Respiratory Research, 12, [55]. https://doi.org/10.1186/1465-9921-12-55

Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease. / 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; Gil, Esther G.

In: Respiratory Research, Vol. 12, 55, 26.04.2011.

Research output: Contribution to journalArticle

Jones, PW, Rennard, SI, Agusti, A, Chanez, P, Magnussen, H, Fabbri, L, Donohue, JF, Bateman, ED, Gross, NJ, Lamarca, R, Caracta, C & Gil, EG 2011, 'Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease', Respiratory Research, vol. 12, 55. https://doi.org/10.1186/1465-9921-12-55
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 ; Gil, Esther G. / Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease. In: Respiratory Research. 2011 ; Vol. 12.
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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).",
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AU - Rennard, Stephen I.

AU - Agusti, Alvar

AU - Chanez, Pascal

AU - Magnussen, Helgo

AU - Fabbri, Leonardo

AU - Donohue, James F.

AU - Bateman, Eric D.

AU - Gross, Nicholas J.

AU - Lamarca, Rosa

AU - Caracta, Cynthia

AU - Gil, Esther G.

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N2 - 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).

AB - 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).

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KW - Anticholinergic

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