Efficacy and safety of umeclidinium added to fluticasone furoate/vilanterol in chronic obstructive pulmonary disease: Results of two randomized studies

Respiratory Medicine

Volumn 109, Issue 9, 2015, Pages 1155-1163

  Siler, Thomas M ^a   Kerwin, Edward ^b   Sousa, Ana R ^c   Donald, Alison ^d   Ali, Rehan ^c   Church, Alison ^d  

^a Midwest Chest Consultants   (United States)

^b Clinical Research Institute of Southern Oregon   (United States)

^c GLAXOSMITHKLINE   (United Kingdom)

^d GLAXOSMITHKLINE   (United States)

Author keywords

Bronchodilation; Inhaled corticosteroid; Long acting beta2 agonist; Long acting muscarinic antagonist

Indexed keywords

FLUTICASONE FUROATE PLUS VILANTEROL; UMECLIDINIUM; ANDROSTANE DERIVATIVE; BENZYL ALCOHOL DERIVATIVE; BETA 2 ADRENERGIC RECEPTOR STIMULATING AGENT; CHLOROBENZENE; DRUG COMBINATION; FLUTICASONE FUROATE; GLUCOCORTICOID; MUSCARINIC RECEPTOR BLOCKING AGENT; QUINUCLIDINE DERIVATIVE; VILANTEROL;

ADULT; ARTICLE; ATRIAL FIBRILLATION; BACKACHE; CARDIOGENIC SHOCK; CARDIOPULMONARY INSUFFICIENCY; CARDIOVASCULAR DISEASE; CEREBROVASCULAR ACCIDENT; CHRONIC OBSTRUCTIVE LUNG DISEASE; CONTROLLED CLINICAL TRIAL (TOPIC); COUGHING; DIARRHEA; DISEASE SEVERITY; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; DYSGEUSIA; FEMALE; FORCED EXPIRATORY VOLUME; GASTRIC ULCER BLEEDING; HEADACHE; HEART ARRHYTHMIA; HEART FAILURE; HEART INFARCTION; HEART MUSCLE ISCHEMIA; HUMAN; INCIDENCE; INFLUENZA; LOWER RESPIRATORY TRACT INFECTION; LUNG FUNCTION; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MULTICENTER STUDY (TOPIC); PNEUMONIA; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); RHINOPHARYNGITIS; ST. GEORGE RESPIRATORY QUESTIONNAIRE; TREATMENT OUTCOME; AGED; CLINICAL TRIAL; COMBINATION DRUG THERAPY; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG COMBINATION; DRUG EFFECTS; MULTICENTER STUDY; PATHOPHYSIOLOGY; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; RANDOMIZED CONTROLLED TRIAL; VITAL CAPACITY;

ADRENERGIC BETA-2 RECEPTOR AGONISTS; AGED; ANDROSTADIENES; BENZYL ALCOHOLS; CHLOROBENZENES; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG COMBINATIONS; DRUG THERAPY, COMBINATION; FEMALE; FORCED EXPIRATORY VOLUME; GLUCOCORTICOIDS; HUMANS; MALE; MIDDLE AGED; MUSCARINIC ANTAGONISTS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; QUALITY OF LIFE; QUINUCLIDINES; VITAL CAPACITY;

EID: 84941737889     PISSN: 09546111     EISSN: 15323064     Source Type: Journal    
DOI: 10.1016/j.rmed.2015.06.006     Document Type: Article

References (36)

1. Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2014. http://www.goldcopd.com/uploads/users/files/GOLD-Report-2014-Oct30.pdf. Date last updated 2014. Date last accessed 22 December 2014.
2. A.J. Guarascio, S.M. Ray, C.K. Finch, and et al. The clinical and economic burden of chronic obstructive pulmonary disease in the USA, Clinicoecon Outcomes. Res. 5 2013 235 245
3. B.R. Celli, and W. MacNee Standards for the diagnosis and treatment of patients with COPD: a summary of the ATS/ERS position paper Eur. Respir. J. 23 2004 932 946
4. GlaxoSmithKline INCRUSE® Summary of Product Characteristics 2014 http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002809/human-med-001755.jsp&mid=WC0b01ac058001d124 Date last updated 22 May 2014. Date last accessed 17 December 2014
5. J.A. Ohar, and J.F. Donohue Mono- and combination therapy of long-acting bronchodilators and inhaled corticosteroids in advanced COPD Semin. Respir. Crit. Care. Med. 31 2010 321 333
6. S.D. Aaron, K.L. Vandemheen, D. Fergusson, and et al. Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial Ann. Intern. Med. 146 2007 545 555
7. D. Singh, J. Brooks, G. Hagan, and et al. Superiority of "triple" therapy with salmeterol/fluticasone propionate and tiotropium bromide versus individual components in moderate to severe COPD Thorax 63 2008 592 598
8. A. Chatterjee, M. Shah, A.O. D'Souza, and et al. Observational study on the impact of initiating tiotropium alone versus tiotropium with fluticasone propionate/salmeterol combination therapy on outcomes and costs in chronic obstructive pulmonary disease Respir. Res. 13 2012 15
9. M. Cazzola, F. Ando, P. Santus, and et al. A pilot study to assess the effects of combining fluticasone propionate/salmeterol and tiotropium on the airflow obstruction of patients with severe-to-very severe COPD Pulm. Pharmacol. Ther. 20 2007 556 561
10. N.A. Hanania, G.D. Crater, A.N. Morris, and et al. Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD Respir. Med. 106 2012 91 101
11. J. Vestbo, C. Vogelmeier, M. Small, and et al. Understanding the GOLD 2011 strategy as applied to a real-world COPD population Respir. Med. 108 2014 729 736
12. GlaxoSmithKline INCRUSE® Prescribing Information 2014 https://www.gsksource.com/gskprm/htdocs/documents/INCRUSE-ELLIPTA-PI-PIL.PDF Last updated 2014. Last accessed 17 December 2014
13. Glaxo Group Limited RELVAR ELLIPTA® Summary of Product Characteristics (European Medicines Agency) 2013 http://www.ema.europa.eu/docs/en-GB/document-library/EPAR---Product-Information/human/002673/WC500157633.pdf Last updated 2013. Last accessed 17 December 2014
14. World Medical Association WMA Declaration of Helsiniki - Ethical Principles for Medical Research Involving Human Subjects 2013 http://www.wma.net/en/30publications/10policies/b3/index.html Last updated October 2013. Last accessed 17 December 2014
15. M. Cazzola, W. MacNee, F.J. Martinez, and et al. Outcomes for COPD pharmacological trials: from lung function to biomarkers Eur. Respir. J. 31 2008 416 469
16. J.F. Donohue Minimal clinically important differences in COPD lung function COPD 2 2005 111 124
17. P.W. Jones, G. Harding, P. Berry, and et al. Development and first validation of the COPD assessment test Eur. Respir. J. 34 2009 648 654
18. P.W. Jones, G. Harding, I. Wiklund, and et al. Tests of the responsiveness of the COPD assessment test following acute exacerbation and pulmonary rehabilitation Chest 142 2012 134 140
19. M. Meguro, E.A. Barley, S. Spencer, and et al. Development and validation of an improved, COPD-specific version of the St. George Respiratory Questionnaire Chest 132 2007 456 463
20. M. Decramer, A. Anzueto, E. Kerwin, and et al. Efficacy and safety of umeclidinium plus vilanterol versus tiotropium, vilanterol, or umeclidinium monotherapies over 24 weeks in patients with chronic obstructive pulmonary disease: results from two multicentre, blinded, randomised controlled trials Lancet. Respir. Med. 2 2014 472 486
21. R. Trivedi, N. Richard, R. Mehta, and et al. Umeclidinium monotherapy in patients with COPD: a randomised, placebo-controlled study Eur. Respir. J. 43 2014 72 81
22. J.F. Donohue, M.R. Maleki-Yazdi, S. Kilbride, and et al. Efficacy and safety of once-daily umeclidinium/vilanterol 62.5/25 mcg in COPD Respir. Med. 107 2013 1538 1546
23. B.R. Celli, G. Crater, S. Kilbride, and et al. Once-daily umeclidinium/vilanterol 125/25 mcg in COPD: a randomized, controlled study Chest 145 2014 981 991
24. P.W. Jones Health status and the spiral of decline COPD 6 2009 59 63
25. E.M. Kerwin, C. Scott-Wilson, L. Sanford, and et al. A randomised trial of fluticasone furoate/vilanterol (50/25 mug; 100/25 mug) on lung function in COPD Respir. Med. 107 2013 560 569
26. C.F. Vogelmeier, E.D. Bateman, J. Pallante, and et al. Efficacy and safety of once-daily QVA149 compared with twice-daily salmeterol-fluticasone in patients with chronic obstructive pulmonary disease (ILLUMINATE): a randomised, double-blind, parallel group study Lancet. Respir. Med. 1 2013 51 60
27. M. Westwood, J. Bourbeau, P.W. Jones, and et al. Relationship between FEV1 change and patient-reported outcomes in randomised trials of inhaled bronchodilators for stable COPD: a systematic review Respir. Res. 12 2011 40
28. P.W. Jones St. George's Respiratory Questionnaire: MCID COPD 2 2005 75 79
29. D.A. Mahler, and T.J. Witek Jr. The MCID of the transition dyspnea index is a total score of one unit COPD 2 2005 99 103
30. S.S. Kon, J.L. Canavan, S.E. Jones, and et al. Minimum clinically important difference for the COPD Assessment Test: a prospective analysis Lancet. Respir. Med. 2 2014 195 203
31. M.L. Watkins, T.K. Wilcox, M. Tabberer, and et al. Shortness of breath with daily activities questionnaire: validation and responder thresholds in patients with chronic obstructive pulmonary disease BMJ. Open 3 2013 e003048
32. F. Braido, I. Baiardini, M. Cazzola, and et al. Long-acting bronchodilators improve health related quality of life in patients with COPD Respir. Med. 107 2013 1465 1480
33. F.J. Martinez, J. Boscia, G. Feldman, and et al. Fluticasone furoate/vilanterol (100/25; 200/25 mug) improves lung function in COPD: a randomised trial Respir. Med. 107 2013 550 559
34. N.A. Hanania, G. Feldman, W. Zachgo, and et al. The efficacy and safety of the novel long-acting beta2 agonist vilanterol in patients with COPD: a randomized placebo-controlled trial Chest 142 2012 119 127
35. J.F. Donohue, D. Niewoehner, J. Brooks, and et al. Safety and tolerability of once-daily umeclidinium/vilanterol 125/25 mcg and umeclidinium 125 mcg in patients with chronic obstructive pulmonary disease: results from a 52-week, randomized, double-blind, placebo-controlled study Respir. Res. 15 2014 78
36. S.F. Ho, M.S. O'Mahony, J.A. Steward, and et al. Dyspnoea and quality of life in older people at home, age Ageing 30 2001 155 159