Efficacy and Safety of a 12-week Treatment with Twice-daily Aclidinium Bromide in COPD Patients (ACCORD COPD I)

References

• Rabe KF, Hurd S, Anzueto A, Global Strategy for the Diagnosis, Management, and Prevention Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med 2007 Sept; 176(6):532–55.
   PubMed Web of Science ®Google Scholar
• Mannino DM, Buist AS. Global burden of COPD: risk factors, prevalence, and future trends. Lancet 2007 Sept; 370(9589):765–73.
   PubMed Web of Science ®Google Scholar
• Hurd S. The impact of COPD on lung health worldwide: epidemiology and incidence. Chest 2000 Feb; 117(2 Suppl):1S–4S.
   PubMed Web of Science ®Google Scholar
• Minino AM, Heron MP, Murphy SL, Kochanek KD. Deaths: final data for 2004. Natl Vital Stat Rep 2007 Aug; 55(19):1–119.
   PubMedGoogle Scholar
• Sentellas S, Ramos I, Alberti J, 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 Mar; 39(5):283–90.
   PubMed Web of Science ®Google Scholar
• Jansat JM, Lamarca R, de Miquel G, Schrodter A, Miletzki B, Gurniak M. 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 Oct; 49(10):1239–46.
   PubMed Web of Science ®Google Scholar
• 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 Jul; 47(7):460–8.
   PubMed Web of Science ®Google Scholar
• Jones PW, Rennard SI, Agusti A, Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease. Respir Res [Internet] 2011 April 26 [cited 2011 April 27];12:55. Available from: http://respiratory-research.com/content/12/1/55.
   Google Scholar
• Cazzola M, MacNee W, Martinez FJ, Outcomes for COPD pharmacological trials: from lung function to biomarkers. Eur Respir J 2008 Feb; 31(2):416–69.
   PubMed Web of Science ®Google Scholar
• Lasseter KC, Dilzer S, Jansat JM, Garcia Gil E, Caracta C, Ortiz S. Safety and pharmacokinetics of multiple doses of aclidinium bromide administered twice daily in healthy volunteers. In: American Thoracic Society International Conference Abstract Issue; 2011 May 13–18; Denver, CO. New York: Am J Respir Crit Care Med; c2011. p. A1615.
   Google Scholar
• Fuhr R, Magnussen H, Sarem K, Efficacy of aclidinium bromide 400 μg BID compared with placebo and tiotropium in patients with moderate-to-severe COPD. Chest [Internet] 2011 September 8 [cited 2011 September 8]:[29 p.]. Available from: http://chestjournal.chestpubs.org/content/early/2011/09/07/chest.11-0406.
   Google Scholar
• Singh D, Magnussen H, Kirsten A-M, Aclidinium bromide: a phase IIb, dose-finding study. In: British Thoracic Society Winter Meeting Programme and Abstracts Issue; 2011 December 7–9; London, UK. London, UK: Thorax; c2011. p. A172.
   Google Scholar
• Miller MR, Hankinson J, Brusasco V, Standardisation of spirometry. Eur Respir J 2005 Aug; 26(2):319–38.
   PubMed Web of Science ®Google Scholar
• Haythornthwaite JA, Hegel MT, Kerns RD. Development of a sleep diary for chronic pain patients. J Pain Symptom Manage 1991 Feb; 6(2):65–72.
   PubMed Web of Science ®Google Scholar
• Jones PW. St. George's Respiratory Questionnaire: MCID. COPD 2005 Mar; 2(1):75–9.
   PubMedGoogle Scholar
• Mahler DA, Witek TJ, Jr. The MCID of the transition dyspnea index is a total score of one unit. COPD 2005 Mar; 2(1):99–103.
   PubMedGoogle Scholar
• Donohue JF. Minimal clinically important differences in COPD lung function. COPD 2005 Mar; 2(1):111–24.
   PubMedGoogle Scholar
• Brusasco V, Hodder R, Miravitlles M, Korducki L, Towse L, Kesten S. Health outcomes following treatment for six months with once daily tiotropium compared with twice daily salmeterol in patients with COPD. Thorax 2003 May; 58(5):399–404.
   PubMed Web of Science ®Google Scholar
• Casaburi R, Mahler DA, Jones PW, A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease. Eur Respir J 2002 Feb; 19(2):217–24.
   PubMed Web of Science ®Google Scholar
• Vincken W, van Noord JA, Greefhorst AP, Improved health outcomes in patients with COPD during 1 yr's treatment with tiotropium. Eur Respir J 2002 Feb; 19(2):209–16.
   PubMed Web of Science ®Google Scholar
• Make BJ. Chronic obstructive pulmonary disease: developing comprehensive management. Respir Care 2003 Dec; 48(12):1225–34; discussion 34–7.
   PubMedGoogle Scholar
• Tashkin DP, Celli B, Senn S, A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med 2008 Oct; 359(15):1543–54.
   PubMed Web of Science ®Google Scholar
• Calverley PM, Spencer S, Willits L, Burge PS, Jones PW. Withdrawal from treatment as an outcome in the ISOLDE study of COPD. Chest 2003 Oct; 124(4):1350–6.
   PubMed Web of Science ®Google Scholar
• Bateman ED, Tashkin D, Siafakas N, A one-year trial of tiotropium Respimat plus usual therapy in COPD patients. Respir Med 2010 Oct; 104(10):1460–72.
   PubMed Web of Science ®Google Scholar
• Bateman E, Singh D, Smith D, Efficacy and safety of tiotropium Respimat SMI in COPD in two 1-year randomized studies. Int J Chron Obstruct Pulmon Dis 2010; 5:197–208.
   PubMedGoogle Scholar
• Mocarski M, Caracta C, Tourkodimitris S, Park G, Garcia Gil E, Setyawan J. Nighttime symptoms of COPD in a clinical trial population: prevalence and impact. In: American Thoracic Society International Conference Abstract Issue; 2011 May 13–18; Denver, CO. New York: Am J Respir Crit Care Med 2011; p. A1495.
   Google Scholar
• 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 Aug; 25(8):2043–8.
   PubMed Web of Science ®Google Scholar
• Kessler R, Partridge MR, Miravitlles M, Symptom variability in patients with severe COPD: a pan-European cross-sectional study. Eur Respir J 2011 Feb; 37(2):264–72.
   PubMed Web of Science ®Google Scholar
• Tashkin DP, Pearle J, Iezzoni D, Varghese ST. Formoterol and tiotropium compared with tiotropium alone for treatment of COPD. COPD 2009 Feb; 6(1):17–25.
   PubMedGoogle Scholar
• Rennard SI, Tashkin DP, McElhattan J, Efficacy and tolerability of budesonide/formoterol in one hydrofluoroalkane pressurized metered-dose inhaler in patients with chronic obstructive pulmonary disease: results from a 1-year randomized controlled clinical trial. Drugs 2009; 69(5):549–65.
   PubMed Web of Science ®Google Scholar
• Anzueto A, Ferguson GT, Feldman G, Effect of fluticasone propionate/salmeterol (250/50) on COPD exacerbations and impact on patient outcomes. COPD 2009 Oct; 6(5):320–9.
   PubMedGoogle Scholar
• Campbell M, Eliraz A, Johansson G, Formoterol for maintenance and as-needed treatment of chronic obstructive pulmonary disease. Respir Med 2005 Dec; 99(12):1511–20.
   PubMed Web of Science ®Google Scholar
• Partridge MR, Schuermann W, Beckman O, Persson T, Polanowski T. Effect on lung function and morning activities of budesonide/formoterol versus salmeterol/fluticasone in patients with COPD. Ther Adv Respir Dis 2009 Aug; 3(4):1–11.
   PubMedGoogle Scholar
• Make B, Hanania NA, ZuWallack R, The efficacy and safety of inhaled fluticasone propionate/salmeterol and ipratropium/albuterol for the treatment of chronic obstructive pulmonary disease: an eight-week, multicenter, randomized, double-blind, double-dummy, parallel-group study. Clin Ther 2005 May; 27(5):531–42.
   PubMed Web of Science ®Google Scholar