PMID- 22320148
OWN - NLM
STAT- MEDLINE
DCOM- 20130329
LR  - 20220408
IS  - 1541-2563 (Electronic)
IS  - 1541-2563 (Linking)
VI  - 9
IP  - 2
DP  - 2012 Apr
TI  - Efficacy and safety of a 12-week treatment with twice-daily aclidinium bromide in 
      COPD patients (ACCORD COPD I).
PG  - 90-101
LID - 10.3109/15412555.2012.661492 [doi]
AB  - BACKGROUND: This Phase III study evaluated the efficacy and safety of twice-daily 
      aclidinium 200 mug and 400 mug versus placebo in the treatment of 
      moderate-to-severe COPD. METHODS: In this 12-week, double-blind, multicenter 
      trial, patients were randomized (1:1:1) to inhaled twice-daily aclidinium 200 mug, 
      aclidinium 400 mug, or placebo. Primary and secondary endpoints were changes from 
      baseline in trough FEV(1) and peak FEV(1) at Week 12, respectively. Health status 
      (St. George's Respiratory Questionnaire [SGRQ]), COPD symptoms (Transitional 
      Dyspnea Index [TDI], night and early morning symptoms), and safety were also 
      assessed. RESULTS: A total of 561 patients (mean age, 64 +/- 9 years) with a mean 
      baseline FEV(1) of 1.36 +/- 0.54 L (47.2% of predicted value) were randomized. At 
      Week 12, aclidinium 200 mug and 400 mug showed significant improvements from 
      baseline in mean (95% CI) trough FEV(1) compared with placebo by 86 (45, 127) mL 
      and 124 (83,164) mL, respectively, and in peak FEV(1) by 146 (101, 190) mL and 192 
      (148, 236) mL, respectively (p </= 0.0001 for all). Both aclidinium doses also 
      provided significant improvements in SGRQ, TDI and almost all COPD symptom scores 
      compared with placebo (p < 0.05 for all). Incidences of adverse events (AEs) were 
      similar across treatment groups. The incidence of anticholinergic AEs was low and 
      similar across groups (dry mouth: 0.5%-1.6%; constipation: 0%-1.1%). CONCLUSIONS: 
      Treatment of moderate-to-severe COPD patients with twice-daily aclidinium 200 mug 
      and 400 mug was associated with significant improvements in bronchodilation, 
      health status, and COPD symptoms. Both doses were well tolerated and had safety 
      profiles similar to placebo. TRIAL REGISTRATION: This ACCORD I study (AClidinium 
      in Chronic Obstructive Respiratory Disease I) was registered on 
      clinicaltrials.gov (NCT00891462) as "Efficacy and Safety of Aclidinium Bromide 
      for Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease 
      (COPD)".
FAU - Kerwin, Edward M
AU  - Kerwin EM
AD  - Clinical Research Institute, Medford, OR 97504, USA. ekerwin@criresearch.com
FAU - D'Urzo, Anthony D
AU  - D'Urzo AD
FAU - Gelb, Arthur F
AU  - Gelb AF
FAU - Lakkis, Hassan
AU  - Lakkis H
FAU - Garcia Gil, Esther
AU  - Garcia Gil E
FAU - Caracta, Cynthia F
AU  - Caracta CF
CN  - ACCORD I study investigators
LA  - eng
SI  - ClinicalTrials.gov/NCT00891462
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120209
PL  - England
TA  - COPD
JT  - COPD
JID - 101211769
RN  - 0 (Muscarinic Antagonists)
RN  - 0 (Tropanes)
RN  - UQW7UF9N91 (aclidinium bromide)
SB  - IM
MH  - Administration, Inhalation
MH  - Adult
MH  - Aged
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Intention to Treat Analysis
MH  - Male
MH  - Middle Aged
MH  - Muscarinic Antagonists/administration & dosage/adverse effects/*therapeutic use
MH  - Pulmonary Disease, Chronic Obstructive/*drug therapy
MH  - Quality of Life
MH  - Spirometry
MH  - Surveys and Questionnaires
MH  - Treatment Outcome
MH  - Tropanes/administration & dosage/adverse effects/*therapeutic use
EDAT- 2012/02/11 06:00
MHDA- 2013/03/30 06:00
CRDT- 2012/02/11 06:00
PHST- 2012/02/11 06:00 [entrez]
PHST- 2012/02/11 06:00 [pubmed]
PHST- 2013/03/30 06:00 [medline]
AID - 10.3109/15412555.2012.661492 [doi]
PST - ppublish
SO  - COPD. 2012 Apr;9(2):90-101. doi: 10.3109/15412555.2012.661492. Epub 2012 Feb 9.