Glycopyrronium once-daily significantly improves lung function and health status when combined with salmeterol/fluticasone in patients with COPD: The GLISTEN study - A randomised controlled trial

Thorax

Volumn 70, Issue 6, 2015, Pages 519-527

  Frith, Peter A ^a   Thompson, Philip J ^b   Ratnavadivel, Rajeev ^c   Chang, Catherina L ^d   Bremner, Peter ^e   Day, Peter ^f   Frenzel, Christina ^g   Kurstjens, Nicol ^g   Waddell, Ainslie ^h   Daniel, Alexander ^h   Khoussousi, Alireza ^h   Springfield, Andrew ^h   Veale, Andrew ^h   Graham, Anthony Neil ^h   Gallagher, Brad ^h   Pande, Braj Raj ^h   O'Kane, Brendan ^h   Jones, Christopher ^h   Baldi, Claudio ^h   Helm, Colin ^h   O'Dochartaigh, Conor ^h   Chambers, Daniel ^h   Quinn, Dean ^h   Yull, Derek ^h   Karthigesu, Dhanalakshi ^h   Then, Edward ^h   Graham, Frank ^h   Faigenbaum, Fred ^h   Geddam, Geetha ^h   Cameron, Gillian ^h   Blom, Hans ^h   Goldman, Hershel ^h   Snell, Hilary ^h   Chia, Imagard ^h   Jeong, James ^h   Liew, James ^h   Salvaris, James ^h   Pryke, Jason ^h   Reid, Jim ^h   Kolbe, John ^h   O'Sullivan, John ^h   Pak, John ^h   Upham, John ^h   Feiber, Joseph ^h   Ford, Judith O'Malley ^h   Yong, Kevin ^h   Perrin, Kyle ^h   Noonan, Lawrence ^h   Atlas, Len ^h   Murdoch, Louise ^h   Pearce, Margaret ^h   Bloch, Mark ^h   Holmes, Mark ^h   Chia, Michael ^h   Epton, Michael ^h   Leadston, Michelle ^h   Tandon, M K ^h   Chitgopeker, Mohan ^h   Liebenberg, Naomi ^h   Hendry, Neil ^h   Olaniyi, Olakunle ^h   Singh, Omesh ^h   Kendall, Peter ^h   Van Niekerk, Peter ^h   Willet, Rodney ^h   Tomlins, Ronald ^h   Pillay, Salven ^h   Sharifeh, Sammy ^h   Carson, Simon ^h   Bingham, Stephen ^h   Walford, Ted ^h   Erasmus, Tersia ^h   Claridge, Trevor ^h   Hess, Zofia ^h   more..

^a REPATRIATION GENERAL HOSPITAL   (Australia)

^b UNIVERSITY OF WESTERN AUSTRALIA   (Australia)

^c GOSFORD HOSPITAL   (Australia)

^d WAIKATO HOSPITAL   (New Zealand)

^e ST JOHN OF GOD HOSPITAL   (Australia)

^f Medical Centre   (Australia)

^g Novartis Pharmaceuticals Australia Pty Limited   (Australia)

^h NONE

Author keywords

[No Author keywords available]

Indexed keywords

FLUTICASONE PROPIONATE PLUS SALMETEROL; GLYCOPYRRONIUM BROMIDE; PLACEBO; SALBUTAMOL; TIOTROPIUM BROMIDE; ANDROSTANE DERIVATIVE; BRONCHODILATING AGENT; FLUTICASONE; SALMETEROL XINAFOATE; SCOPOLAMINE DERIVATIVE;

ACUTE CORONARY SYNDROME; AGED; ANGINA PECTORIS; ARTICLE; ATRIAL FIBRILLATION; ATRIOVENTRICULAR BLOCK; BACKACHE; CHRONIC OBSTRUCTIVE LUNG DISEASE; COMBINATION CHEMOTHERAPY; CONGESTIVE HEART FAILURE; CONTROLLED STUDY; COUGHING; DIARRHEA; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG WITHDRAWAL; DYSPHONIA; DYSPNEA; FATIGUE; FEMALE; FORCED EXPIRATORY VOLUME; HEADACHE; HEALTH STATUS; HEART ARRHYTHMIA; HEART ATRIUM FLUTTER; HEART LEFT VENTRICLE FAILURE; HEART PALPITATION; HEART VENTRICLE FIBRILLATION; HUMAN; HYPERTENSION; INHALER; ISCHEMIC CARDIOMYOPATHY; LIVER ISCHEMIA; LOWER RESPIRATORY TRACT INFECTION; LUNG FUNCTION; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MORNING DOSAGE; MULTICENTER STUDY; MULTIPLE ORGAN FAILURE; MUSCLE SPASM; NAUSEA; OROPHARYNX PAIN; PARALLEL DESIGN; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; RHINORRHEA; SINGLE BLIND PROCEDURE; SINUSITIS; SMALL INTESTINE OBSTRUCTION; ST. GEORGE RESPIRATORY QUESTIONNAIRE; TACHYCARDIA; THRUSH; UNSPECIFIED SIDE EFFECT; UPPER RESPIRATORY TRACT INFECTION; VIRAL RESPIRATORY TRACT INFECTION; XEROSTOMIA; ANALOGS AND DERIVATIVES; AUSTRALIA; CLINICAL TRIAL; COMPARATIVE STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG ADMINISTRATION; DRUG COMBINATION; DRUG EFFECTS; INHALATIONAL DRUG ADMINISTRATION; MIDDLE AGED; NEW ZEALAND; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; QUESTIONNAIRE; RISK FACTOR; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

ADMINISTRATION, INHALATION; AGED; ALBUTEROL; ANDROSTADIENES; AUSTRALIA; BRONCHODILATOR AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; FEMALE; FLUTICASONE; FORCED EXPIRATORY VOLUME; GLYCOPYRROLATE; HEALTH STATUS; HUMANS; MALE; MIDDLE AGED; NEW ZEALAND; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; RISK FACTORS; SALMETEROL XINAFOATE; SCOPOLAMINE DERIVATIVES; SEVERITY OF ILLNESS INDEX; SURVEYS AND QUESTIONNAIRES; TIOTROPIUM BROMIDE; TREATMENT OUTCOME;

EID: 84933524786     PISSN: 00406376     EISSN: 14683296     Source Type: Journal    
DOI: 10.1136/thoraxjnl-2014-206670     Document Type: Article

References (35)

1. The Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD), 2014. http://www.goldcopd.org
2. Tashkin DP, Celli B, Senn S, et al. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med 2008; 359: 1543-54.
3. Karner C, Chong J, Poole P. Tiotropium versus placebo for chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2012; 7: CD009285.
4. Beeh KM, Singh D, Di Scala L, et al. Once-daily NVA237 improves exercise tolerance from the first dose in patients with COPD: the GLOW3 trial. Int J Chron Obstruct Pulmon Dis 2012; 7: 503-13.
5. Calverley P, Pauwels R, Vestbo J, et al. Combined salmeterol and fluticasone in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial. Lancet 2003; 361: 449-56.
6. Donohue JF, Fogarty C, Lotvall J, et al. Once-daily bronchodilators for chronic obstructive pulmonary disease: indacaterol versus tiotropium. Am J Respir Crit Care Med 2010; 182: 155-62.
7. Dahl R, Chung KF, Buhl R, et al. Efficacy of a new once-daily long-acting inhaled beta2-agonist indacaterol versus twice-daily formoterol in COPD. Thorax 2010; 65: 473-9.
8. Calverley PM, Boonsawat W, Cseke Z, et al. Maintenance therapy with budesonide and formoterol in chronic obstructive pulmonary disease. Eur Respir J 2003; 22: 912-19.
9. Mahler DA, Wire P, Horstman D, et al. Effectiveness of fluticasone propionate and salmeterol combination delivered via the Diskus device in the treatment of chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2002; 166: 1084-91.
10. Calverley PM, Anderson JA, Celli B, et al. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med 2007; 356: 775-89.
11. Kew KM, Dias S, Cates CJ. Long-acting inhaled therapy (beta-agonists, anticholinergics and steroids) for COPD: a network meta-analysis. Cochrane Database Syst Rev 2014; 3: CD010844.
12. Nannini LJ, Poole P, Milan SJ, et al. Combined corticosteroid and long-acting beta (2)-agonist in one inhaler versus placebo for chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2013; 11: CD003794.
13. Wedzicha JA, Calverley PM, Seemungal TA, et al. The prevention of chronic obstructive pulmonary disease exacerbations by salmeterol/fluticasone propionate or tiotropium bromide. Am J Respir Crit Care Med 2008; 177: 19-26.
14. Karner C, Cates CJ. Combination inhaled steroid and long-acting beta(2)-agonist in addition to tiotropium versus tiotropium or combination alone for chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2011; (3): CD008532.
15. Cazzola M, Ando F, Santus P, 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 2007; 20: 556-61.
16. Chapman KR, Beeh KM, Beier J, et al. A blinded evaluation of the efficacy and safety of glycopyrronium, a once-daily long-acting muscarinic antagonist, versus tiotropium, in patients with COPD: the GLOW5 study. BMC Pulm Med 2014; 14: 4.
17. Kerwin E, Hebert J, Gallagher N, et al. Efficacy and safety of NVA237 versus placebo and tiotropium in patients with COPD: the GLOW2 study. Eur Respir J 2012; 40: 1106-14.
18. D'Urzo A, Ferguson GT, van Noord JA, et al. Efficacy and safety of once-daily NVA237 in patients with moderate-to-severe COPD: the GLOW1 trial. Respir Res 2011; 12: 156.
19. Global Initiative for Chronic Obstructive Lung Disease (GOLD): Global strategy for diagnosis, management and prevention of COPD, 2010. http://www.goldcopd.org/Guidelines/guideline-2010-gold-report.html
20. Miller MR, Hankinson J, Brusasco V, et al. Standardisation of spirometry. Eur Respir J 2005; 26: 319-38.
21. Medical Dictionary of Medical Activities (MedDRA). Version 15.1, 2012.
22. Bourbeau J, Sebaldt RJ, Day A, et al. Practice patterns in the management of chronic obstructive pulmonary disease in primary practice: the CAGE study. Can Respir J 2008; 15: 13-19.
23. White P, Thornton H, Pinnock H, et al. Overtreatment of COPD with inhaled corticosteroids - implications for safety and costs: cross-sectional observational study. PLoS One 2013; 8: e75221.
24. Aaron SD, Vandemheen KL, Fergusson D, et al. Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial. Ann Intern Med 2007; 146: 545-55.
25. Welte T, Miravitlles M, Hernandez P, et al. Efficacy and tolerability of budesonide/formoterol added to tiotropium in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2009; 180: 741-50.
26. Singh D, Brooks J, Hagan G, et al. Superiority of "triple" therapy with salmeterol/fluticasone propionate and tiotropium bromide versus individual components in moderate to severe COPD. Thorax 2008; 63: 592-8.
27. Fang LZ, Liang X, Zhang JQ, et al. [Combination of inhaled salmeterol/fluticasone and tiotropium in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial]. Zhonghua Jie He He Hu XiZa Zhi 2008; 31: 811-14.
28. Hanania NA, Crater GD, Morris AN, et al. Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD. Respir Med 2012; 106: 91-101.
29. Jung KS, Park HY, Park SY, et al. Comparison of tiotropium plus fluticasone propionate/salmeterol with tiotropium in COPD: a randomized controlled study. Respir Med 2012; 106: 382-9.
30. Rodrigo GJ, Plaza V, Castro-Rodriguez JA. Comparison of three combined pharmacological approaches with tiotropium monotherapy in stable moderate to severe COPD: a systematic review. Pulm Pharmacol Ther 2012; 25: 40-7.
31. Siler T, Kerwin E, Sousa A, et al. Efficacy and safety of once-daily umeclidinium added to fluticasone furoate/vilanterol in chronic obstructive pulmonary disease: results of two replicate randomized 12-week studies. Chest 2014; 146 (4-MeetingAbstracts): 340A.
32. Magnussen H, Watz H, Kirsten A, et al. Stepwise withdrawal of inhaled corticosteroids in COPD patients receiving dual bronchodilation: WISDOM study design and rationale. Respir Med 2014; 108: 593-9.
33. Bateman ED, Ferguson GT, Barnes N, et al. Dual bronchodilation with QVA149 versus single bronchodilator therapy: the SHINE study. Eur Respir J 2013; 42: 1484-94.
34. Decramer M, Anzueto A, Kerwin E, 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 2014; 2: 472-86.
35. Jones PW, Beeh KM, Chapman KR, et al. Minimal clinically important differences in pharmacological trials. Am J Respir Crit Care Med 2014; 189: 250-5.