PMID- 23916502
OWN - NLM
STAT- MEDLINE
DCOM- 20140910
LR  - 20220408
IS  - 1532-3064 (Electronic)
IS  - 0954-6111 (Linking)
VI  - 107
IP  - 12
DP  - 2013 Dec
TI  - Long-term safety and efficacy of twice-daily aclidinium bromide in patients with 
      COPD.
PG  - 1957-65
LID - S0954-6111(13)00254-0 [pii]
LID - 10.1016/j.rmed.2013.07.001 [doi]
AB  - BACKGROUND: Aclidinium is a novel, long-acting muscarinic antagonist indicated 
      for maintenance treatment of COPD. METHODS: In this 52-week, parallel-group, 
      double-blind study, patients with moderate-to-severe COPD were randomized (1:1) 
      to receive aclidinium twice-daily (BID) 200 mug or 400 mug via a novel, dry powder 
      inhaler (Genuair((R))/Pressair((R))) [Registered trademarks of Almirall, SA, 
      Barcelona, Spain for use within the European Union, Iceland, Norway, and 
      Switzerland as Genuair((R)) and within the United States as Pressair((R))]. Safety, 
      the primary objective, was assessed via adverse events (AEs), clinical laboratory 
      tests, vital signs, and 12-lead electrocardiograms. Efficacy was evaluated using 
      spirometry, SGRQ, and rescue medication use. RESULTS: A total of 605 patients 
      were randomized in the study. The percentage of patients reporting any 
      treatment-emergent AE (TEAE) was comparable between groups; most TEAEs were mild 
      or moderate. Anticholinergic TEAEs were reported by low percentages of patients 
      in either treatment group (dry mouth: 200 mug, 1.3%; 400 mug, 2.7%; constipation: 
      200 mug, 2.9%; 400 mug, 1.7%). Cardiac TEAEs were also reported by a low percentage 
      of patients (<2% for any event in any group) and did not appear to be dose 
      dependent. There were no clinically relevant abnormalities in other safety 
      outcomes. Both aclidinium 200 mug and 400 mug resulted in improvements from 
      baseline to Week 52 in FEV1, with numerically greater increases observed with the 
      higher dose. Clinically important improvements in SGRQ scores and a reduction in 
      rescue medication use were observed throughout the study for both doses. 
      CONCLUSIONS: Long-term treatment with aclidinium 200 mug or 400 mug BID was well 
      tolerated, with sustained benefits in lung function and health status in patients 
      with COPD throughout the 1-year study.
CI  - Copyright (c) 2013 Elsevier Ltd. All rights reserved.
FAU - Gelb, Arthur F
AU  - Gelb AF
AD  - Southern California Clinical Trials, 3650 E. South Street, Suite 308, Lakewood, 
      CA 90805, USA. Electronic address: afgelb@msn.com.
FAU - Tashkin, Donald P
AU  - Tashkin DP
FAU - Make, Barry J
AU  - Make BJ
FAU - Zhong, Xiaoyun
AU  - Zhong X
FAU - Garcia Gil, Esther
AU  - Garcia Gil E
FAU - Caracta, Cynthia
AU  - Caracta C
CN  - LAS-MD-35 study investigators
LA  - eng
GR  - NCT01044459/PHS HHS/United States
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
DEP - 20130731
PL  - England
TA  - Respir Med
JT  - Respiratory medicine
JID - 8908438
RN  - 0 (Muscarinic Antagonists)
RN  - 0 (Tropanes)
RN  - UQW7UF9N91 (aclidinium bromide)
SB  - IM
MH  - Administration, Inhalation
MH  - Adult
MH  - Aged
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Drug Repositioning
MH  - Dry Powder Inhalers
MH  - Female
MH  - Forced Expiratory Volume/drug effects
MH  - Health Status
MH  - Heart Diseases/chemically induced
MH  - Humans
MH  - Long-Term Care
MH  - Male
MH  - Middle Aged
MH  - Muscarinic Antagonists/*administration & dosage/adverse effects
MH  - Pulmonary Disease, Chronic Obstructive/*drug therapy
MH  - Treatment Outcome
MH  - Tropanes/*administration & dosage/adverse effects
OTO - NOTNLM
OT  - Aclidinium
OT  - Bronchodilation
OT  - COPD
OT  - Health status
OT  - Safety
OT  - Tolerability
EDAT- 2013/08/07 06:00
MHDA- 2014/09/11 06:00
CRDT- 2013/08/07 06:00
PHST- 2012/10/03 00:00 [received]
PHST- 2013/05/06 00:00 [revised]
PHST- 2013/07/01 00:00 [accepted]
PHST- 2013/08/07 06:00 [entrez]
PHST- 2013/08/07 06:00 [pubmed]
PHST- 2014/09/11 06:00 [medline]
AID - S0954-6111(13)00254-0 [pii]
AID - 10.1016/j.rmed.2013.07.001 [doi]
PST - ppublish
SO  - Respir Med. 2013 Dec;107(12):1957-65. doi: 10.1016/j.rmed.2013.07.001. Epub 2013 
      Jul 31.