Efficacy and safety of a 12-week treatment with twice-daily aclidinium bromide in COPD patients (ACCORD COPD I)

COPD: Journal of Chronic Obstructive Pulmonary Disease

Volumn 9, Issue 2, 2012, Pages 90-101

  Kerwin, Edward M ^a   D'Urzo, Anthony D ^b   Gelb, Arthur F ^c   Lakkis, Hassan ^d   Gil, Esther Garcia ^e   Caracta, Cynthia F ^d  

^a Clinical Research Institute   (United States)

^b UNIVERSITY OF TORONTO   (Canada)

^c CALIFORNIA CLINICAL TRIALS   (United States)

^d FOREST RESEARCH INSTITUTE   (United States)

^e Almirall SA ^*  (Spain)

Author keywords

Aclidinium; COPD; Lung function

Indexed keywords

ACLIDINIUM BROMIDE; CORTICOSTEROID; PLACEBO; PREDNISONE; SALBUTAMOL;

ADULT; AGED; ARTICLE; CHRONIC OBSTRUCTIVE LUNG DISEASE; CONSTIPATION; CONTROLLED STUDY; DISEASE EXACERBATION; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEMALE; FORCED EXPIRATORY VOLUME; HEART DISEASE; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PHASE 3 CLINICAL TRIAL; PREDICTIVE VALUE; PRIORITY JOURNAL; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; ST. GEORGE'S RESPIRATORY QUESTIONNAIRE; TRANSITIONAL DYSPNEA INDEX; XEROSTOMIA;

ADMINISTRATION, INHALATION; ADULT; AGED; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; FOLLOW-UP STUDIES; HUMANS; INTENTION TO TREAT ANALYSIS; MALE; MIDDLE AGED; MUSCARINIC ANTAGONISTS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; QUALITY OF LIFE; QUESTIONNAIRES; SPIROMETRY; TREATMENT OUTCOME; TROPANES;

EID: 84859305834     PISSN: 15412555     EISSN: 15412563     Source Type: Journal    
DOI: 10.3109/15412555.2012.661492     Document Type: Article

References (34)

1. Rabe KF, Hurd S, Anzueto A, et al. Global Strategy for the Diagnosis, Management, and Prevention Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med 2007 Sept; 176(6):532-55. (Pubitemid 47403272)
2. Mannino DM, Buist AS. Global burden of COPD: risk factors, prevalence, and future trends. Lancet 2007 Sept; 370(9589):765-73. (Pubitemid 47321908)
3. Hurd S. The impact of COPD on lung health worldwide: epidemiology and incidence. Chest 2000 Feb; 117(2 Suppl):1S-4S. (Pubitemid 30111555)
4. Minino AM, Heron MP, Murphy SL, Kochanek KD. Deaths: fi nal data for 2004. Natl Vital Stat Rep 2007 Aug; 55(19):1-119.
5. 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 Mar; 39(5):283-90.
6. 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.
7. 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.
8. Jones PW, Rennard SI, Agusti A, et al. Effi cacy 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.
9. Cazzola M, MacNee W, Martinez FJ, et al. Outcomes for COPD pharmacological trials: from lung function to biomarkers. Eur Respir J 2008 Feb; 31(2):416-69.
10. 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.
11. Fuhr R, Magnussen H, Sarem K, et al. Effi cacy 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.
12. Singh D, Magnussen H, Kirsten A-M, et al. Aclidinium bromide: a phase IIb, dose-fi nding study. In: British Thoracic Society Winter Meeting Programme and Abstracts Issue; 2011 December 7-9; London, UK. London, UK: Thorax; c2011. p. A172.
13. Miller MR, Hankinson J, Brusasco V, et al. Standardisation of spirometry. Eur Respir J 2005 Aug; 26(2):319-38. (Pubitemid 41079078)
14. 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.
15. Jones PW. St. George's Respiratory Questionnaire: MCID. COPD 2005 Mar; 2(1):75-9.
16. 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. (Pubitemid 40776229)
17. Donohue JF. Minimal clinically important diff erences in COPD lung function. COPD 2005 Mar; 2(1):111-24. (Pubitemid 40776231)
18. 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. (Pubitemid 36560942)
19. Casaburi R, Mahler DA, Jones PW, et al. A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease. Eur Respir J 2002 Feb; 19(2):217-24. (Pubitemid 34162820)
20. Vincken W, Van Noord JA, Greefhorst AP, et al. Improved health outcomes in patients with COPD during 1 yr's treatment with tiotropium. Eur Respir J 2002 Feb; 19(2):209-16. (Pubitemid 34162819)
21. Make BJ. Chronic obstructive pulmonary disease: developing comprehensive management. Respir Care 2003 Dec; 48(12):1225-34; discussion 34-7.
22. Tashkin DP, Celli B, Senn S, et al. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med 2008 Oct; 359(15):1543-54.
23. 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. (Pubitemid 37290045)
24. Bateman ED, Tashkin D, Siafakas N, et al. A one-year trial of tiotropium Respimat plus usual therapy in COPD patients. Respir Med 2010 Oct; 104(10):1460-72.
25. Bateman E, Singh D, Smith D, et al. Effi cacy and safety of tiotropium Respimat SMI in COPD in two 1-year randomized studies. Int J Chron Obstruct Pulmon Dis 2010; 5:197-208.
26. 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.
27. 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.
28. 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 Feb; 37(2):264-72.
29. 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.
30. Rennard SI, Tashkin DP, McElhattan J, et al. Effi cacy and tolerability of budesonide/formoterol in one hydrofl uoroalkane pressurized metered-dose inhaler in patients with chronic obstructive pulmonary disease: results Effi cacy of aclidinium BID in COPD patients 101 www.copdjournal.com from a 1-year randomized controlled clinical trial. Drugs 2009; 69(5):549-65.
31. Anzueto A, Ferguson GT, Feldman G, et al. Effect of fl uticasone propionate/salmeterol (250/50) on COPD exacerbations and impact on patient outcomes. COPD 2009 Oct; 6(5):320-9.
32. Campbell M, Eliraz A, Johansson G, et al. Formoterol for maintenance and as-needed treatment of chronic obstructive pulmonary disease. Respir Med 2005 Dec; 99(12):1511-20. (Pubitemid 41683932)
33. Partridge MR, Schuermann W, Beckman O, Persson T, Polanowski T. Effect on lung function and morning activities of budesonide/formoterol versus salmeterol/fl uticasone in patients with COPD. Ther Adv Respir Dis 2009 Aug; 3(4):1-11.
34. Make B, Hanania NA, ZuWallack R, et al. The effi cacy and safety of inhaled fl uticasone 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 (Pubitemid 40835964)