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

Stephen I. Rennard, Paul D. Scanlon, Gary T. Ferguson, Ludmyla Rekeda, Brian T. Maurer, Esther Garcia Gil, Cynthia F. Caracta

Research output: Contribution to journalArticle

31 Citations (Scopus)

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 (FEV1) 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.

Original languageEnglish (US)
Pages (from-to)893-904
Number of pages12
JournalClinical Drug Investigation
Volume33
Issue number12
DOIs
StatePublished - Dec 1 2013

Fingerprint

Dyspnea
Chronic Obstructive Pulmonary Disease
Randomized Controlled Trials
Safety
Placebos
Bronchial Spasm
Lung
Muscarinic Antagonists
Forced Expiratory Volume
Cholinergic Antagonists
Therapeutics
Double-Blind Method
Health Status
Mouth
aclidinium bromide
Surveys and Questionnaires

ASJC Scopus subject areas

  • Pharmacology (medical)

Cite this

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. / Rennard, Stephen I.; Scanlon, Paul D.; Ferguson, Gary T.; Rekeda, Ludmyla; Maurer, Brian T.; Garcia Gil, Esther; Caracta, Cynthia F.

In: Clinical Drug Investigation, Vol. 33, No. 12, 01.12.2013, p. 893-904.

Research output: Contribution to journalArticle

Rennard, Stephen I. ; Scanlon, Paul D. ; Ferguson, Gary T. ; Rekeda, Ludmyla ; Maurer, Brian T. ; Garcia Gil, Esther ; Caracta, Cynthia F. / 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. In: Clinical Drug Investigation. 2013 ; Vol. 33, No. 12. pp. 893-904.
@article{148c41ffe3cf4fdd8f1f5ac51ecc04bd,
title = "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{\circledR}/Pressair{\circledR}. 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 (FEV1) 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.",
author = "Rennard, {Stephen I.} and Scanlon, {Paul D.} and Ferguson, {Gary T.} and Ludmyla Rekeda and Maurer, {Brian T.} and {Garcia Gil}, Esther and Caracta, {Cynthia F.}",
year = "2013",
month = "12",
day = "1",
doi = "10.1007/s40261-013-0138-1",
language = "English (US)",
volume = "33",
pages = "893--904",
journal = "Clinical Drug Investigation",
issn = "1173-2563",
publisher = "Adis International Ltd",
number = "12",

}

TY - JOUR

T1 - ACCORD COPD II

T2 - A randomized clinical trial to evaluate the 12-week efficacy and safety of twice-daily aclidinium bromide in chronic obstructive pulmonary disease patients

AU - Rennard, Stephen I.

AU - Scanlon, Paul D.

AU - Ferguson, Gary T.

AU - Rekeda, Ludmyla

AU - Maurer, Brian T.

AU - Garcia Gil, Esther

AU - Caracta, Cynthia F.

PY - 2013/12/1

Y1 - 2013/12/1

N2 - 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 (FEV1) 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.

AB - 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 (FEV1) 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.

UR - http://www.scopus.com/inward/record.url?scp=84890299585&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84890299585&partnerID=8YFLogxK

U2 - 10.1007/s40261-013-0138-1

DO - 10.1007/s40261-013-0138-1

M3 - Article

C2 - 24085591

AN - SCOPUS:84890299585

VL - 33

SP - 893

EP - 904

JO - Clinical Drug Investigation

JF - Clinical Drug Investigation

SN - 1173-2563

IS - 12

ER -