Onset of Effect of Aclidinium, a Novel, Long-Acting Muscarinic Antagonist, in Patients with COPD

Jørgen Vestbo, Claus Vogelmeier, Jacques Creemers, Meritxell Falques, Anna Ribera, Esther Garcia Gil

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

Aclidinium bromide is a novel, long-acting, inhaled muscarinic antagonist in development for the treatment of chronic obstructive pulmonary disease (COPD). The aim of this study was to assess the rate of onset of bronchodilation with aclidinium compared with placebo and tiotropium. This was a double-blind, double-dummy, multicenter, crossover study in COPD patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥30% and <60% predicted. On study days, patients received single doses of aclidinium 200 μg, tiotropium 18 μg, or placebo. Serial spirometry was conducted from 10 minutes to 3 hours post-dose. The primary variable was the percentage of patients with an increase in FEV1 of ≥10% above baseline at 30 minutes post-dose. Other assessments included change from baseline in FEV1 and dyspnea over 3 hours post-dose. A total of 115 patients entered the study. Significantly more patients had an increase in FEV1 of ≥10% above baseline at 30 minutes with aclidinium and tiotropium versus placebo (49.5% and 51.8% versus 13.8%; p < 0.0001). At 30 minutes, the relative increase from baseline in FEV1 was significantly higher for aclidinium and tiotropium versus placebo (12% and 11% versus 3%; p < 0.0001). Aclidinium and tiotropium also significantly increased FEV1 (p < 0.01) and improved the perception of dyspnea compared with placebo at all measured time points from 10 minutes to 3 hours post-dose. In conclusion, aclidinium provided effective bronchodilation, similar to that seen with tiotropium, with significant improvements compared with placebo observed from 10 minutes post-dose.
OriginalsprogEngelsk
TidsskriftC O P D
Vol/bind7
Udgave nummer5
Sider (fra-til)331-336
Antal sider6
ISSN1541-2555
DOI
StatusUdgivet - sep. 2010
Udgivet eksterntJa

Fingeraftryk

Muscarinic Antagonists
Forced Expiratory Volume
Chronic Obstructive Pulmonary Disease
Placebos
Cross-Over Studies
Multicenter Studies
Tiotropium Bromide

Emneord

  • Aclidinium bromide
  • Bronchodilation
  • Chronic obstructive pulmonary disease
  • Muscarinic antagonist
  • Onset of action

Citer dette

Vestbo, Jørgen ; Vogelmeier, Claus ; Creemers, Jacques ; Falques, Meritxell ; Ribera, Anna ; Gil, Esther Garcia. / Onset of Effect of Aclidinium, a Novel, Long-Acting Muscarinic Antagonist, in Patients with COPD. I: C O P D. 2010 ; Bind 7, Nr. 5. s. 331-336.
@article{72201d97c4e1446f9229ba773b193315,
title = "Onset of Effect of Aclidinium, a Novel, Long-Acting Muscarinic Antagonist, in Patients with COPD",
abstract = "Aclidinium bromide is a novel, long-acting, inhaled muscarinic antagonist in development for the treatment of chronic obstructive pulmonary disease (COPD). The aim of this study was to assess the rate of onset of bronchodilation with aclidinium compared with placebo and tiotropium. This was a double-blind, double-dummy, multicenter, crossover study in COPD patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥30{\%} and <60{\%} predicted. On study days, patients received single doses of aclidinium 200 μg, tiotropium 18 μg, or placebo. Serial spirometry was conducted from 10 minutes to 3 hours post-dose. The primary variable was the percentage of patients with an increase in FEV1 of ≥10{\%} above baseline at 30 minutes post-dose. Other assessments included change from baseline in FEV1 and dyspnea over 3 hours post-dose. A total of 115 patients entered the study. Significantly more patients had an increase in FEV1 of ≥10{\%} above baseline at 30 minutes with aclidinium and tiotropium versus placebo (49.5{\%} and 51.8{\%} versus 13.8{\%}; p < 0.0001). At 30 minutes, the relative increase from baseline in FEV1 was significantly higher for aclidinium and tiotropium versus placebo (12{\%} and 11{\%} versus 3{\%}; p < 0.0001). Aclidinium and tiotropium also significantly increased FEV1 (p < 0.01) and improved the perception of dyspnea compared with placebo at all measured time points from 10 minutes to 3 hours post-dose. In conclusion, aclidinium provided effective bronchodilation, similar to that seen with tiotropium, with significant improvements compared with placebo observed from 10 minutes post-dose.",
keywords = "Aclidinium bromide, Bronchodilation, Chronic obstructive pulmonary disease, Muscarinic antagonist, Onset of action",
author = "J{\o}rgen Vestbo and Claus Vogelmeier and Jacques Creemers and Meritxell Falques and Anna Ribera and Gil, {Esther Garcia}",
year = "2010",
month = "9",
doi = "10.3109/15412555.2010.510158",
language = "English",
volume = "7",
pages = "331--336",
journal = "C O P D",
issn = "1541-2555",
publisher = "Taylor & Francis",
number = "5",

}

Onset of Effect of Aclidinium, a Novel, Long-Acting Muscarinic Antagonist, in Patients with COPD. / Vestbo, Jørgen; Vogelmeier, Claus; Creemers, Jacques; Falques, Meritxell; Ribera, Anna; Gil, Esther Garcia.

I: C O P D, Bind 7, Nr. 5, 09.2010, s. 331-336.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Onset of Effect of Aclidinium, a Novel, Long-Acting Muscarinic Antagonist, in Patients with COPD

AU - Vestbo, Jørgen

AU - Vogelmeier, Claus

AU - Creemers, Jacques

AU - Falques, Meritxell

AU - Ribera, Anna

AU - Gil, Esther Garcia

PY - 2010/9

Y1 - 2010/9

N2 - Aclidinium bromide is a novel, long-acting, inhaled muscarinic antagonist in development for the treatment of chronic obstructive pulmonary disease (COPD). The aim of this study was to assess the rate of onset of bronchodilation with aclidinium compared with placebo and tiotropium. This was a double-blind, double-dummy, multicenter, crossover study in COPD patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥30% and <60% predicted. On study days, patients received single doses of aclidinium 200 μg, tiotropium 18 μg, or placebo. Serial spirometry was conducted from 10 minutes to 3 hours post-dose. The primary variable was the percentage of patients with an increase in FEV1 of ≥10% above baseline at 30 minutes post-dose. Other assessments included change from baseline in FEV1 and dyspnea over 3 hours post-dose. A total of 115 patients entered the study. Significantly more patients had an increase in FEV1 of ≥10% above baseline at 30 minutes with aclidinium and tiotropium versus placebo (49.5% and 51.8% versus 13.8%; p < 0.0001). At 30 minutes, the relative increase from baseline in FEV1 was significantly higher for aclidinium and tiotropium versus placebo (12% and 11% versus 3%; p < 0.0001). Aclidinium and tiotropium also significantly increased FEV1 (p < 0.01) and improved the perception of dyspnea compared with placebo at all measured time points from 10 minutes to 3 hours post-dose. In conclusion, aclidinium provided effective bronchodilation, similar to that seen with tiotropium, with significant improvements compared with placebo observed from 10 minutes post-dose.

AB - Aclidinium bromide is a novel, long-acting, inhaled muscarinic antagonist in development for the treatment of chronic obstructive pulmonary disease (COPD). The aim of this study was to assess the rate of onset of bronchodilation with aclidinium compared with placebo and tiotropium. This was a double-blind, double-dummy, multicenter, crossover study in COPD patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥30% and <60% predicted. On study days, patients received single doses of aclidinium 200 μg, tiotropium 18 μg, or placebo. Serial spirometry was conducted from 10 minutes to 3 hours post-dose. The primary variable was the percentage of patients with an increase in FEV1 of ≥10% above baseline at 30 minutes post-dose. Other assessments included change from baseline in FEV1 and dyspnea over 3 hours post-dose. A total of 115 patients entered the study. Significantly more patients had an increase in FEV1 of ≥10% above baseline at 30 minutes with aclidinium and tiotropium versus placebo (49.5% and 51.8% versus 13.8%; p < 0.0001). At 30 minutes, the relative increase from baseline in FEV1 was significantly higher for aclidinium and tiotropium versus placebo (12% and 11% versus 3%; p < 0.0001). Aclidinium and tiotropium also significantly increased FEV1 (p < 0.01) and improved the perception of dyspnea compared with placebo at all measured time points from 10 minutes to 3 hours post-dose. In conclusion, aclidinium provided effective bronchodilation, similar to that seen with tiotropium, with significant improvements compared with placebo observed from 10 minutes post-dose.

KW - Aclidinium bromide

KW - Bronchodilation

KW - Chronic obstructive pulmonary disease

KW - Muscarinic antagonist

KW - Onset of action

U2 - 10.3109/15412555.2010.510158

DO - 10.3109/15412555.2010.510158

M3 - Journal article

VL - 7

SP - 331

EP - 336

JO - C O P D

JF - C O P D

SN - 1541-2555

IS - 5

ER -