title: Effect of Aclidinium Bromide on Exacerbations in Patients with Moderate-to-Severe COPD: A Pooled Analysis of Five Phase III, Randomized, Placebo-Controlled Studies.
abstract: We investigated the effect of the long-acting muscarinic antagonist aclidinium bromide on chronic obstructive pulmonary disease (COPD) exacerbations by pooling data from five randomized, placebo-controlled, parallel-group Phase III studies of 3-6 months' duration. Data were pooled from the aclidinium 400 μg twice-daily (BID) and placebo arms (N  =  2,521) and stratified by Global initiative for chronic Obstructive Lung Disease (GOLD) group (A, B, C and D). Results showed that fewer patients experienced ≥1 exacerbation with aclidinium (any severity: 12.5%; moderate to severe: 10.9%) compared with placebo (any severity: 15.7%; moderate to severe: 13.3%) and the odds of experiencing ≥1 exacerbation of any severity were reduced in patients receiving aclidinium (odds ratio  =   0.78, p  =  0.039). Furthermore, aclidinium reduced the rate of exacerbations compared with placebo (any severity: rate ratio  =  0.79, p  =  0.026; moderate to severe: 0.80, p  =  0.044). The time to first exacerbation of any severity was delayed with aclidinium compared with placebo (hazard ratio  =  0.79, p  =  0.026) and there was a numerical delay in time to first moderate-to-severe exacerbation. Finally, the effects of aclidinium on exacerbations versus placebo were greater in patients in GOLD Groups B and D; however, it is of note that only 10.7% of patients were classified in Group A or C. In summary, the results indicate that aclidinium 400 μg BID reduces the frequency of COPD exacerbations compared with placebo and that these effects are greater in symptomatic patients.
authors.affiliation: a Airways Disease Section, National Heart and Lung Institute, Imperial College London , London , UK.
authors.forename: Jadwiga A
authors.initials: JA
authors.lastname: Wedzicha
authors.affiliation: b Institut del Tòrax, Hospital Clínic, IDIBAPS, Universitat de Barcelona and CIBER Enfermedades Respiratorias , Barcelona , Spain.
authors.forename: Alvar
authors.initials: A
authors.lastname: Agusti
authors.affiliation: a Airways Disease Section, National Heart and Lung Institute, Imperial College London , London , UK.
authors.forename: Gavin
authors.initials: G
authors.lastname: Donaldson
authors.affiliation: c AstraZeneca R&D Centre , Barcelona , Spain.
authors.forename: Ferran
authors.initials: F
authors.lastname: Chuecos
authors.affiliation: c AstraZeneca R&D Centre , Barcelona , Spain.
authors.forename: Rosa
authors.initials: R
authors.lastname: Lamarca
authors.affiliation: c AstraZeneca R&D Centre , Barcelona , Spain.
authors.forename: Esther
authors.initials: E
authors.lastname: Garcia Gil
mesh_terms: D000368:Aged; D017326:Clinical Trials, Phase III as Topic; D018450:Disease Progression; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000503:physiopathology; D016032:Randomized Controlled Trials as Topic; D012720:Severity of Illness Index; D000067251:Symptom Flare Up; D013997:Time Factors; D014326:Tropanes / Q000008:administration & dosage / Q000627:therapeutic use*; D014797:Vital Capacity
chemical_list: D018727:Muscarinic Antagonists; D014326:Tropanes; C542859:aclidinium bromide
keywords: GOLD; long-acting muscarinic antagonist; symptoms