Long-term safety and efficacy of indacaterol, a long-acting β2-agonist, in subjects with COPD: A randomized, placebo-controlled study

Chest

Volumn 140, Issue 1, 2011, Pages 68-75

  Chapman, Kenneth R ^a,b   Rennard, Stephen I ^c   Dogra, Angeli ^e   Owen, Roger ^d   Lassen, Cheryl ^d   Kramer, Benjamin ^e  

^a TORONTO WESTERN HOSPITAL   (Canada)

^b UNIVERSITY OF TORONTO   (Canada)

^c UNIVERSITY OF NEBRASKA MEDICAL CENTER   (United States)

^d NOVARTIS HORSHAM RESEARCH CENTRE   (United Kingdom)

^e NOVARTIS PHARMA AG   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

GLUCOSE; INDACATEROL; PLACEBO; POTASSIUM;

ADULT; ARTHRALGIA; ARTICLE; CHRONIC OBSTRUCTIVE LUNG DISEASE; CONTROLLED STUDY; COUGHING; DISEASE EXACERBATION; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FATALITY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; FORCED EXPIRATORY VOLUME; GLUCOSE BLOOD LEVEL; HEALTH STATUS; HEART INFARCTION; HUMAN; MAJOR CLINICAL STUDY; MALE; MUSCLE SPASM; MUSCULOSKELETAL PAIN; POTASSIUM BLOOD LEVEL; PRIORITY JOURNAL; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; ST GEORGE RESPIRATORY QUESTIONNAIRE;

EID: 79960405028     PISSN: 00123692     EISSN: 19313543     Source Type: Journal    
DOI: 10.1378/chest.10-1830     Document Type: Article

References (36)

1. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. GOLD Web site. http://www.goldcopd.org/Guidelineitem.asp?l1=2&l2= 1&intId=989. Accessed February 1, 2010.
2. Restrepo RD, Alvarez MT, Wittnebel LD, et al. Medication adherence issues in patients treated for COPD. Int J Chron Obstruct Pulmon Dis. 2008;3(3):371-384.
3. Bourbeau J, Bartlett SJ. Patient adherence in COPD. Thorax. 2008;63(9):831-838.
4. 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(8): 2043-2048.
5. Cazzola M, Matera MG, Lötvall J. Ultra long-acting beta 2-agonists in development for asthma and chronic obstructive pulmonary disease. Expert Opin Investig Drugs. 2005; 14(7):775-783. (Pubitemid 41030946)
6. Feldman G, Siler T, Prasad N, et al; INLIGHT 1 study group. Efficacy and safety of indacaterol 150 microg once-daily in COPD: a double-blind, randomised, 12-week study. BMC Pulm Med. 2010;10:11.
7. 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;4:253-263.
8. Calverley PM, Anderson JA, Celli B, et al; TORCH Investigators. Cardiovascular events in patients with COPD: TORCH study results. Thorax. 2010;65(8):719-725.
9. Global Initiative for Chronic Obstructive Lung Disease. Workshop report: 2005 update, global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. GOLD Web site. http://www.goldcopd.org/ Guidelineitem.asp?l1=2&l2=1&intId=1620. September 2005. Accessed February 1, 2010.
10. Donohue JF, Fogarty C, Lötvall J, et al; INHANCE Study Investigators. Once-daily bronchodilators for chronic obstructive pulmonary disease: indacaterol versus tiotropium. Am J Respir Crit Care Med. 2010;182(2):155-162.
11. Miller MR, Hankinson J, Brusasco V, et al; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005; 26(2):319-338.
12. Jones PW, Quirk FH, Baveystock CM, Littlejohns P. A self-complete measure of health status for chronic airflow limitation. The St. George's Respiratory Questionnaire. Am Rev Respir Dis. 1992;145(6):1321-1327.
13. Jones PW. St. George's Respiratory Questionnaire: MCID. COPD. 2005;2(1):75-79.
14. Holguin F, Folch E, Redd SC, Mannino DM. Comorbidity and mortality in COPD-related hospitalizations in the United States, 1979 to 2001. Chest. 2005;128(4):2005-2011.
15. Soriano JB, Visick GT, Muellerova H, Payvandi N, Hansell AL. Patterns of comorbidities in newly diagnosed COPD and asthma in primary care. Chest. 2005;128(4):2099-2107. (Pubitemid 41507547)
16. Barr RG, Celli BR, Mannino DM, et al. Comorbidities, patient knowledge, and disease management in a national sample of patients with COPD. Am J Med. 2009;122(4):348-355.
17. US Food and Drug Administration. Drugs@FDA. Label information for salmeterol and formoterol. US Food and Drug Administration Web site. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction 5 Search.Label-ApprovalHistory#apphist. Accessed March 3, 2010.
18. Boyd G, Morice AH, Pounsford JC, Siebert M, Peslis N, Crawford C. An evaluation of salmeterol in the treatment of chronic obstructive pulmonary disease (COPD). Eur Respir J. 1997;10(4):815-821. (Pubitemid 27180192)
19. 2-agonist indacaterol versus twice-daily formoterol in COPD. Thorax. 2010;65(6):473-479.
20. Kornmann O, Dahl R, Centanni S, et al. Once-daily indacaterol vs twice-daily salmeterol for COPD: a placebo-controlled comparison. Eur Respir J. 2011;37(2):273-279.
21. Cazzola M, MacNee W, Martinez FJ, et al; American Thoracic Society; European Respiratory Society Task Force on outcomes of COPD. Outcomes for COPD pharmacological trials: from lung function to biomarkers. Eur Respir J. 2008;31(2):416-469.
22. Rossi A, Kristufek P, Levine BE, et al; Formoterol in Chronic Obstructive Pulmonary Disease (FICOPD) II Study Group. Comparison of the efficacy, tolerability, and safety of formoterol dry powder and oral, slow-release theophylline in the treatment of COPD. Chest. 2002;121(4):1058-1069.
23. Donohue JF, Menjoge S, Kesten S. Tolerance to bronchodilating effects of salmeterol in COPD. Respir Med. 2003;97(9): 1014-1020. (Pubitemid 37098766)
24. Tsagaraki V, Amfilochiou A, Markantonis SL. Evidence of tachyphylaxis associated with salmeterol treatment of chronic obstructive pulmonary disease patients. Int J Clin Pract. 2006; 60(4):415-421.
25. Jones PW, Agusti AG. Outcomes and markers in the assessment of chronic obstructive pulmonary disease. Eur Respir J. 2006;27(4):822-832. (Pubitemid 44914209)
26. Calverley P, Pauwels R, Vestbo J, et al. Combined salmeterol and fluticasone in the treatment of chronic obstructive pulmonary disease:a randomised controlled trial [published correction appears in Lancet. 2003;361(9369):1660]. Lancet. 2003;361(9356):449-456. (Pubitemid 36173708)
27. Calverley PM, Anderson JA, Celli B, et al; TORCH investigators. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med. 2007;356(8):775-789. (Pubitemid 46294610)
28. Tashkin DP, Celli B, Senn S, et al; UPLIFT Study Investigators. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med. 2008;359(15):1543-1554.
29. Tashkin DP, Rennard SI, Martin P, et al. Efficacy and safety of budesonide and formoterol in one pressurized metered-dose inhaler in patients with moderate to very severe chronic obstructive pulmonary disease: results of a 6-month randomized clinical trial. Drugs. 2008;68(14):1975-2000.
30. Rennard SI, Tashkin DP, McElhattan J, et al. 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):549-565.
31. Campbell M, Eliraz A, Johansson G, et al. Formoterol for maintenance and as-needed treatment of chronic obstructive pulmonary disease. Respir Med. 2005;99(12):1511-1520. (Pubitemid 41683932)
32. Oga T, Nishimura K, Tsukino M, Sato S, Hajiro T. Analysis of the factors related to mortality in chronic obstructive pulmonary disease: role of exercise capacity and health status. Am J Respir Crit Care Med. 2003;167(4):544-549.
33. Miravitlles M, Calle M, Alvarez-Gutierrez F, Gobartt E, López F, Martín A. Exacerbations, hospital admissions and impaired health status in chronic obstructive pulmonary disease. Qual Life Res. 2006;15(3):471-480.
34. Halpin DM, Peterson S, Larsson TP, Calverley PM. Identifying COPD patients at increased risk of mortality: predictive value of clinical study baseline data. Respir Med. 2008; 102(11):1615-1624.
35. Jones PW, Bosh TK. Quality of life changes in COPD patients treated with salmeterol. Am J Respir Crit Care Med. 1997; 155(4):1283-1289. (Pubitemid 27172772)
36. Jones PW. Monitoring and outcomes. In: Stockley R, Rennard S, Rabe K, Celli B, eds. Chronic Obstructive Pulmonary Disease. Blackwell Publishing; Malden, MA;2007:181-188.