Aclidinium bromide for the treatment of chronic obstructive pulmonary disease

Expert Opinion on Pharmacotherapy

Volumn 14, Issue 9, 2013, Pages 1205-1214

  Cazzola, Mario ^a,b   Page, Clive P ^c   Matera, Maria Gabriella ^d  

^a UNIVERSITY OF ROME TOR VERGATA   (Italy)

^b IRCCS SAN RAFFAELE PISANA   (Italy)

^c KING'S COLLEGE LONDON   (United Kingdom)

^d SECOND UNIVERSITY OF NAPLES   (Italy)

Author keywords

Aclidinium bromide; Chronic obstructive pulmonary disease; Night time symptoms; Safety

Indexed keywords

ACLIDINIUM BROMIDE; IPRATROPIUM BROMIDE; PLACEBO; TIOTROPIUM BROMIDE;

AEROBIC METABOLISM; AREA UNDER THE CURVE; ARTICLE; BRONCHODILATATION; CHRONIC OBSTRUCTIVE LUNG DISEASE; CLOSED ANGLE GLAUCOMA; CONSTIPATION; DISEASE SEVERITY; DOSAGE SCHEDULE COMPARISON; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG EFFICACY; DRUG METABOLISM; DRUG SAFETY; DRUG STRUCTURE; DRUG TOLERABILITY; DYSPNEA; ENDURANCE TRAINING; FORCED EXPIRATORY VOLUME; HEART ATRIUM FIBRILLATION; HEART ATRIUM FLUTTER; HEART INFARCTION; HUMAN; IN VITRO STUDY; IN VIVO STUDY; LUNG FUNCTION; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; NONHUMAN; OPEN ANGLE GLAUCOMA; PHARMACODYNAMICS; PHARMACOKINETICS; PHASE 3 CLINICAL TRIAL (TOPIC); PNEUMONIA; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); SICK SINUS SYNDROME; SINGLE DRUG DOSE; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT DURATION; URINARY TRACT INFECTION; XEROSTOMIA;

ADMINISTRATION, INHALATION; ANIMALS; BRONCHODILATOR AGENTS; CLINICAL TRIALS, PHASE III AS TOPIC; DRY POWDER INHALERS; HUMANS; MUSCARINIC ANTAGONISTS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; QUALITY OF LIFE; SCOPOLAMINE DERIVATIVES; TROPANES;

EID: 84877892895     PISSN: 14656566     EISSN: 17447666     Source Type: Journal    
DOI: 10.1517/14656566.2013.789021     Document Type: Article

References (55)

1. Canning BJ. Reflex regulation of airway smooth muscle tone. J Appl Physiol 2006;101:971-85
2. Cazzola M, Page CP, Calzetta L, Matera MG. Pharmacology and therapeutics of bronchodilators. Pharmacol Rev 2012;64:450-504
3. Meurs H, Dekkers BG, Maarsingh H, et al. Muscarinic receptors on airway mesenchymal cells: novel findings for an ancient target. Pulm Pharmacol Ther 2013;26:145-55
4. Scullion JE. The development of anticholinergics in the management of COPD. Int J Chron Obstruct Pulmon Dis 2007;2:33-40
5. Matera MG, Page CP, Cazzola M. Novel bronchodilators for the treatment of chronic obstructive pulmonary disease. Trends Pharmacol Sci 2011;32:495-506
6. Global Initiative for Obstructive Lung Disease GOLD. 2011. Global strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease. Available from: http://www.goldcopd.com [Last accessed 18 January 2013]
7. Dal Negro RW, Bonadiman L, Micheletto C, et al. Changes of clinical outcomes and health care resources in moderate and in severe COPD treated uniquely with tiotropium 18 mug od for twenty-four months. Pulm Pharmacol Ther 2011;24:373-6
8. Cazzola M, Segreti A, Bettoncelli G, et al. Change in asthma and COPD prescribing by Italian general practitioners between 2006 and 2008. Prim Care Respir J 2011;20:291-8
9. Cazzola M, Calzetta L, Bettoncelli G, et al. Cardiovascular disease in asthma and COPD: a population-based retrospective cross-sectional study. Respir Med 2012;106:249-5
10. Matera MG, Calzetta L, Segreti A, Cazzola M. Emerging drugs for chronic obstructive pulmonary disease. Expert Opin Emerg Drugs 2012;17:61-82
11. Cazzola M, Page C, Matera MG. Long-acting muscarinic receptor antagonists for the treatment of respiratory disease. Pulm Pharmacol Ther 2012;doi: 10.1016/j.pupt.2012.12.006
12. Prat M, Fernandez D, Buil MA, et al. Discovery of novel quaternary ammonium derivatives of (3R)-quinuclidinol esters as potent and long-acting muscarinic antagonists with potential for minimal systemic exposure after inhaled administration: identification of (3R)-3-{[hydroxy(di-2-thienyl)acetyl] oxy}-1-(3-phenoxypropyl)-1-azoniabicyclo[2.2.2]octane bromide (aclidinium bromide). J Med Chem 2009;52:5076-92
13. Cazzola M. Aclidinium bromide, a novel long-acting muscarinic M3 antagonist for the treatment of COPD. Curr Opin Investig Drugs 2009;10:482-90
14. Gavalda A, Miralpeix M, Ramos I, et al. Characterization of aclidinium bromide, a novel inhaled muscarinic antagonist, with long duration of action and a favorable pharmacological profile. J Pharmacol Exp Ther 2009;331:740-51
15. Miralpeix M, Milara J, Gabarda E, et al. Functional profile of aclidinium bromide in isolated human bronchi and left atria (abstract). Am J Respir Crit Care Med 2011;183:A1583
16. Milara J, Serrano A, Peiro T, et al. Aclidinium inhibits human lung fibroblast to myofibroblast transition. Thorax 2012;67:229-37
17. Gavalda A, Gras J, Llupia J, et al. Aclidinium bromide, a novel long-acting muscarinic antagonist for COPD with improved preclinical renal and urinary safety profile. Life Sci 2012;90:301-5
18. Sentellas S, Ramos I, Alberti J, et al. Aclidinium bromide, a new, long-acting, inhaled muscarinic antagonist: in vitro plasma inactivation and pharmacological activity of its main metabolites. Eur J Pharm Sci 2010;39:283-90
19. Alberti J, Martinet A, Sentellas S, Salva M. Identification of the human enzymes responsible for the enzymatic hydrolysis of aclidinium bromide. Drug Metab Dispos 2010;38:1202-10
20. Alberti JJ, Sentellas S, Salva M. In vitro liver metabolism of aclidinium bromide in preclinical animal species and humans: identification of the human enzymes involved in its oxidative metabolism. Biochem Pharmacol 2011;81:761-76
21. Ortiz S, Flach S, Ho J, et al. Mass balance and metabolism of aclidinium bromide following intravenous administration of [14C]-aclidinium bromide in healthy subjects. Biopharm Drug Dispos 2012;33:39-45
22. Ortiz S, Flach S, Caracta C, et al. Safety and tolerability of aclidinium administered intravenously and absolute bioavailability of inhaled aclidinium in healthy male participants. J Clin Pharmacol 2012;52:819-27
23. Jansat JM, Lamarca R, Garcia Gil E, Ferrer P. Safety and pharmacokinetics of single doses of aclidinium bromide, a novel long-acting, inhaled antimuscarinic, in healthy subjects. Int J Clin Pharmacol Ther 2009;47:460-8
24. Jansat JM, Lamarca R, de Miquel G, et al. Safety and pharmacokinetics of multiple doses of aclidinium bromide, a novel long-acting muscarinic antagonist for the treatment of chronic obstructive pulmonary disease, in healthy participants. J Clin Pharmacol 2009;49:1239-46
25. Lasseter K, Dilzer S, Jansat JM, et al. Safety and pharmacokinetics of multiple doses of aclidinium bromide administered twice daily in healthy volunteers. Pulm Pharmacol Ther 2012;25:193-9
26. Schmid K, Pascual S, Garcia Gil E, et al. Pharmacokinetics and safety of aclidinium bromide, a muscarinic antagonist, in adults with normal or impaired renal function: a phase I, open-label, single-dose clinical trial. Clin Ther 2010;32:1798-812
27. de la Motte S, Beier J, Schmid K, et al. Pharmacokinetics and safety of aclidinium bromide in younger and elderly patients with chronic obstructive pulmonary disease. Int J Clin Pharmacol Ther 2012;50:403-12
28. Schelfhout VJ, Ferrer P, Jansat JM, et al. Activity of aclidinium bromide, a new long-acting muscarinic antagonist: a phase I study. Br J Clin Pharmacol 2010;69:458-64
29. Lasseter KC, Aubets J, Chuecos F, Garcia Gil E. Aclidinium bromide, a long-acting antimuscarinic, does not affect QT interval in healthy subjects. J Clin Pharmacol 2011;51:923-32
30. Vestbo J, Vogelmeier C, Creemers J, et al. Onset of effect of aclidinium, a novel, long-acting muscarinic antagonist, in patients with COPD. COPD 2010;7:331-6
31. Joos GF, Schelfhout VJ, Pauwels RA, et al. Bronchodilatory effects of aclidinium bromide, a long-acting muscarinic antagonist, in COPD patients. Respir Med 2010;104:865-72
32. Chanez P, Burge PS, Dahl R, et al. Aclidinium bromide provides long-acting bronchodilation in patients with COPD. Pulm Pharmacol Ther 2010;23:15-21
33. Fuhr R, Magnussen H, Sarem K, et al. Efficacy of aclidinium bromide 400 mug twice daily compared with placebo and tiotropium in patients with moderate to severe COPD. Chest 2012;141:745-52
34. Singh D, Magnussen H, Kirsten A, et al. A randomised, placebo-and active-controlled dose-finding study of aclidinium bromide administered twice a day in COPD patients. Pulm Pharmacol Ther 2012;25:248-53
35. Jones PW, Rennard SI, Agusti A, et al. Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease. Respir Res 2011;12:55
36. Kerwin EM, D'Urzo AD, Gelb AF, et al. Efficacy and safety of a 12-week treatment with twice-daily aclidinium bromide in COPD patients (ACCORD COPD I). COPD 2012;9:90-101
37. Jones PW, Singh D, Bateman ED, et al. Efficacy and safety of twice-daily aclidinium bromide in COPD patients: the ATTAIN study. Eur Respir J 2012;40:830-6
38. Gelb AF, Make BJ, Tashkin DP, et al. Long-term efficacy and safety of twice-daily aclidinium bromide in COPD patients: a one-year study (abstract). Am J Respir Crit Care Med 2012;185:A225
39. D'Urzo AD, Kerwin EM, Donohue JF, et al. Long-term extension study of ACCORD COPD I: effects of two doses of twice-daily aclidinium bromide in COPD patients (abstract). Am J Respir Crit Care Med 2012;185:A2913
40. Maltais F, Celli B, Casaburi R, et al. Aclidinium bromide improves exercise endurance and lung hyperinflation in patients with moderate to severe COPD. Respir Med 2011;105:580-7
41. Wu K, Looby M, Pillai G, et al. Population pharmacodynamic model of the longitudinal FEV1 response to an inhaled long-acting anti-muscarinic in COPD patients. J Pharmacokinet Pharmacodyn 2011;38:105-19
42. Partridge MR, Karlsson N, Small IR. Patient insight into the impact of chronic obstructive pulmonary disease in the morning: an internet survey. Curr Med Res Opin 2009;25:2043-8
43. Kessler R, Partridge MR, Miravitlles M, et al. Symptom variability in patients with severe COPD: a pan-European cross-sectional study. Eur Respir J 2011;37:264-72
44. Cazzola M, Rogliani P, Segreti A, Matera MG. An update on bronchodilators in Phase I and II clinical trials. Expert Opin Investig Drugs 2012;21:1489-501
45. Ulrik CS. Aclidinium bromide: clinical benefit in patients with moderate to severe COPD. Open Respir Med J 2012;6:150-4
46. Calverley PM, Lee A, Towse L, et al. Effect of tiotropium bromide on circadian variation in airflow limitation in chronic obstructive pulmonary disease. Thorax 2003;58:855-60
47. Halpin DM, Decramer M, Celli B, et al. Exacerbation frequency and course of COPD. Int J Chron Obstruct Pulmon Dis 2012;7:653-61
48. Wedzicha JA, Decramer M, Seemungal TA. The role of bronchodilator treatment in the prevention of exacerbations of COPD. Eur Respir J 2012;40:1545-54
49. Hilleman DE, Malesker MA, Morrow LE, Schuller D. A systematic review of the cardiovascular risk of inhaled anticholinergics in patients with COPD. Int J Chron Obstruct Pulmon Dis 2009;4:253-63
50. Pieper MP, Chaudhary NI, Park JE. Acetylcholine-induced proliferation of fibroblasts and myofibroblasts in vitro is inhibited by tiotropium bromide. Life Sci 2007;80:2270-3
51. Chrystyn H, Niederlaender C. The Genuair® inhaler: a novel, multidose dry powder inhaler. Int J Clin Pract 2012;66:309-17
52. Hass C, Engdahl K, Albert W, et al. Patient preferences and perceived ease of use in inhaler features: genuair vs. other inhalers (abstract). Chest 2010;138:484A
53. Cazzola M, Molimard M. The scientific rationale for combining long-acting beta2-agonists and muscarinic antagonists in COPD. Pulm Pharmacol Ther 2010;23:257-67
54. Cazzola M, Rogliani P, Matera MG. Aclidinium bromide/formoterol fumarate fixed-dose combination for the treatment of chronic obstructive pulmonary disease. Expert Opin Pharmacother 2013;14:775-81
55. Aparici M, Gomez-Angelats M, Vilella D, et al. Pharmacological characterization of abediterol, a novel inhaled beta2-adrenoceptor agonist with long duration of action and a favorable safety profile in preclinical models. J Pharmacol Exp Ther 2012;342:497-509