Efficacy and safety of QVA149 compared to the concurrent administration of its monocomponents indacaterol and glycopyrronium: The BEACON study

International Journal of COPD

Volumn 8, Issue , 2013, Pages 501-508

  Dahl, Ronald ^a   Jadayel, Dalal ^b   Alagappan, Vijay K T ^c   Chen, Hungta ^c   Banerji, Donald ^c  

^a ODENSE UNIVERSITY HOSPITAL   (Denmark)

^b NOVARTIS HORSHAM RESEARCH CENTRE   (United Kingdom)

^c NOVARTIS PHARMA AG   (Switzerland)

Author keywords

COPD; FEV1 AUC0 4 hours; LABA; LAMA; Rescue medication

Indexed keywords

BREEZHALER; BRONCHODILATING AGENT; CORTICOSTEROID; GLYCOPYRRONIUM BROMIDE; INDACATEROL; PLACEBO; QVA 149; SALBUTAMOL; UNCLASSIFIED DRUG;

ADULT; AGED; AORTA ANEURYSM; AREA UNDER THE CURVE; ARTICLE; CARDIOVASCULAR DISEASE; CEREBROVASCULAR DISEASE; CHRONIC OBSTRUCTIVE LUNG DISEASE; CONTROLLED STUDY; COUGHING; DEATH; DEPRESSION; DIARRHEA; DISEASE CLASSIFICATION; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG USE; DYSPHONIA; DYSPNEA; FEMALE; FORCED EXPIRATORY VOLUME; HEADACHE; HUMAN; INFLUENZA; INHALER; LIGAMENT INJURY; MAJOR CLINICAL STUDY; MALE; MASTALGIA; MULTICENTER STUDY; MYALGIA; PARALLEL DESIGN; PNEUMONIA; QT INTERVAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SCORING SYSTEM; SIDE EFFECT; SYMPTOM; THORAX PAIN; TREATMENT DURATION;

COPD; FEV1 AUC0-4 HOURS; LABA; LAMA; RESCUE MEDICATION;

ADMINISTRATION, INHALATION; ADRENERGIC BETA-2 RECEPTOR AGONISTS; AGED; BRONCHODILATOR AGENTS; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DRUG COMBINATIONS; DRUG THERAPY, COMBINATION; FEMALE; FORCED EXPIRATORY VOLUME; GLYCOPYRROLATE; HUMANS; INDANS; LUNG; MALE; MIDDLE AGED; MUSCARINIC ANTAGONISTS; NEBULIZERS AND VAPORIZERS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; QUINOLONES; SEVERITY OF ILLNESS INDEX; TIME FACTORS; TREATMENT OUTCOME;

EID: 84885907768     PISSN: 11769106     EISSN: 11782005     Source Type: Journal    
DOI: 10.2147/COPD.S49615     Document Type: Article

References (29)

1. Global initiative for chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. 2010 update. Global Initiative for Chronic Obstructive Lung Disease, Inc; 2010. Available from: http://www.goldcopd.org/uploads/users/files/GOLDReport_April112011.pdf. Accessed on July 20, 2012.
2. Karner C, Cates CJ. Long-acting beta(2)-agonist in addition to tiotropium versus either tiotropium or long-acting beta(2)-agonist alone for chronic obstructive pulmonary disease [review]. Cochrane Database Syst Rev. 2012;4: CD008989.
3. Mahler DA, D'Urzo A, Bateman ED, et al; INTRUST-1 and INTRUST-2 study investigators. Concurrent use of indacaterol plus tiotropium in patients with COPD provides superior bronchodilation compared with tiotropium alone: a randomised, double-blind comparison. Thorax. 2012;67(9):781-788.
4. Rabe KF, Timmer W, Sagkriotis A, Viel K. Comparison of a combination of tiotropium plus formoterol to salmeterol plus fluticasone in moderate COPD. Chest. 2008;134(2):255-262.
5. Tashkin DP, Celli BR, Decramer M, Lystig T, Liu D, Kesten S. Efficacy of tiotropium in COPD patients with FEV1 $ 60% participating in the UPLIFT® trial. COPD. 2012;9(3):289-296.
6. van Noord JA, Aumann JL, Janssens E, et al. Comparison of tiotropium once daily, formoterol twice daily and both combined once daily in patients with COPD. Eur Respir J. 2005;26(2):214-222.
7. van Noord JA, Aumann JL, Janssens E, et al. Effects of tiotropium with and without formoterol on airflow obstruction and resting hyperinflation in patients with COPD. Chest. 2006;129(3):509-517.
8. van Noord JA, Buhl R, Laforce C, et al. QVA149 demonstrates superior bronchodilation compared with indacaterol or placebo in patients with chronic obstructive pulmonary disease. Thorax. 2010;65(12): 1086-1091.
9. Szmidt M. The influence of treatment with formoterol, formoterol with tiotropium, formoterol with inhaled glucocorticosteroid and tiotropium on lung functions, tolerance of exercise and simple, morning everyday activities in patients with chronic obstructive pulmonary disease (COPD). Pneumonol Alergol Pol. 2012;80(3):255-262. Polish [with English abstract].
10. Yu AP, Guérin A, Ponce de Leon D, et al. Therapy persistence and adherence in patients with chronic obstructive pulmonary disease: multiple versus single long-acting maintenance inhalers. J Med Econ. 2011;14(4):486-496.
11. Beeh KM, Singh D, Di Scala L, Drollmann A. 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: 503-513.
12. 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.
13. Dahl R, Chung KF, Buhl R, et al; INVOLVE (INdacaterol: Value in COPD: Longer Term Validation of Efficacy and Safety) Study Investigators. Efficacy of a new once-daily long-acting inhaled beta2-agonist indacaterol versus twice-daily formoterol in COPD. Thorax. 2010;65: 473-479.
14. 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.
15. Kerwin E, Hébert 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(5):1106-1114.
16. Kornmann O, Dahl R, Centanni S, et al; INLIGHT-2 (Indacaterol Efficacy Evaluation Using 150-μg Doses with COPD Patients) study investigators. Once-daily indacaterol versus twice-daily salmeterol for COPD: a placebo-controlled comparison. Eur Respir J. 2011;37(2): 273-279.
17. Bateman ED, Ferguson GT, Barnes N, et al. Dual bronchodilation with QVA149 versus single bronchodilator therapy: the SHINE study. Eur Respir J. Epub 2013 May 30.
18. Dahl R, Chapman KR, Rudolf M, et al. Safety and efficacy of dual bronchodilation with QVA149 in COPD patients: the ENLIGHTEN study. Respir Med. 2013;107(10):1558-1567.
19. Vogelmeier CF, Bateman ED, Pallante J, 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 Resp Med. 2013;1(1):51-60.
20. Wedzicha JA, Decramer M, Ficker JH, Sandstorm T, Taylor AF. Dual bronchodilator treatment for the prevention of exacerbations of chronic obstructive pulmonary disease: the SPARK Study. Lancet Resp Med. 2013;1:199-209.
21. Mahler DA, Decramer M, D'Urzo A, et al. Superior lung function with once-daily QVA149 translates into improvements in patient-reported breathlessness compared with placebo and tiotropium in COPD patients: the BLAZE study. Am J Respir Crit Care Med. 2013;187:A6070.
22. Novartis Pharmaceuticals. Comparison of safety and efficacy of the combination product QVA149 A against the concurrent administration of the individual components, QAB149 and NVA237, in patients with chronic obstructive pulmonary disease (COPD) (BEACON). Available from: http://clinicaltrials.gov/ct2/show/NCT01529632. NLM identifier: NCT01529632. Accessed August 23, 2013.
23. Novartis Pharmaceuticals. Efficacy and safety of QVA149 in patients with chronic obstructive pulmonary disease (COPD). Available from: http://www.clinicaltrials.gov/ct2/show/NCT00570778?term=NCT00570778&rank=1.NLM identifier: NCT00570778. Accessed February 25, 2013.
24. Cazzola M, Tashkin DP. Combination of formoterol and tiotropium in the treatment of COPD: effects on lung function. COPD. 2009;6(5):404-415.
25. Berton DC, Reis M, Siqueira AC, et al. Effects of tiotropium and formoterol on dynamic hyperinflation and exercise endurance in COPD. Respir Med. 2010;104(9):1288-1296.
26. Jones PW, Donohue JF, Nedelman J, Pascoe S, Pinault G, Lassen C. Correlating changes in lung function with patient outcomes in chronic obstructive pulmonary disease: a pooled analysis. Respir Res. 2011; 12:161.
27. Antón E. How and when to use inhaled corticosteroids in chronic obstructive pulmonary disease? Expert Rev Respir Med. 2013;7(Suppl 2):25-32.
28. Van de Maele B, Fabbri LM, Martin C, Horton R, Dolker M, Overend T. Cardiovascular safety of QVA149, a combination of Indacaterol and NVA237, in COPD patients. COPD. 2010;7(6):418-427.
29. Carreiro A, Santos J, Rodrigues F. Impact of comorbidities in pulmonary rehabilitation outcomes in patients with chronic obstructive pulmonary disease. Rev Port Pneumol. 2013;19(3):106-113. Portuguese [with English abstract].