Skip to main content
Top
Published in: Drugs 4/2014

01-03-2014 | Adis Drug Evaluation

QVA149 (Indacaterol/Glycopyrronium Fixed-Dose Combination): A Review of Its Use in Patients with Chronic Obstructive Pulmonary Disease

Author: James E. Frampton

Published in: Drugs | Issue 4/2014

Login to get access

Abstract

QVA149 (indacaterol/glycopyrronium) [Xoterna® Breezhaler®, Ultibro® Breezhaler®] is an inhaled fixed-dose combination of indacaterol (a long-acting selective β2-adrenergic receptor agonist [LABA]) and glycopyrronium (a long-acting muscarinic receptor antagonist [LAMA]) that has been approved in the EU and Japan for the symptomatic control of chronic obstructive pulmonary disease (COPD) in adults. In phase III studies, QVA149 significantly improved bronchodilation versus indacaterol, glycopyrronium or tiotropium alone and the LABA/inhaled corticosteroid fixed-dose combination salmeterol/fluticasone. These improvements in lung function, which were rapid in onset and maintained during long-term treatment, were generally associated with significant improvements in dyspnoea, health status, COPD exacerbation risk, patient symptoms, and rescue medication use. The SHINE and ILLUMINATE studies in low (exacerbation) risk patients with moderate to severe disease suggest that QVA149 may offer more symptomatic relief than tiotropium and salmeterol/fluticasone. Similarly, the SPARK study in high (exacerbation) risk patients with severe or very severe disease showed that QVA149 was more effective than glycopyrronium in preventing moderate to severe exacerbations, and suggests that QVA149 may offer more symptomatic relief than LAMA monotherapy. Another phase III study comparing QVA149 with salmeterol/fluticasone in high-risk patients with moderate to very severe disease (FLAME) is ongoing. QVA149 is generally well tolerated, with no new safety signals identified compared with its monocomponents. Bronchodilators remain central to the symptomatic management of COPD. When dual bronchodilation is indicated, QVA149 offers the convenience of two bronchodilators in a single inhaler coupled with a simple, once-daily dosing regimen that may encourage better treatment adherence. Therefore, it is a valuable option in the treatment of COPD.
Literature
1.
go back to reference McKeage K. Indacaterol: a review of its use as maintenance therapy in patients with chronic obstructive pulmonary disease. Drugs. 2012;72(4):543–63.CrossRefPubMed McKeage K. Indacaterol: a review of its use as maintenance therapy in patients with chronic obstructive pulmonary disease. Drugs. 2012;72(4):543–63.CrossRefPubMed
2.
go back to reference Carter NJ. Inhaled glycopyrronium bromide: a review of its use in patients with moderate to severe chronic obstructive pulmonary disease. Drugs. 2013;73(7):741–53.CrossRefPubMed Carter NJ. Inhaled glycopyrronium bromide: a review of its use in patients with moderate to severe chronic obstructive pulmonary disease. Drugs. 2013;73(7):741–53.CrossRefPubMed
6.
go back to reference Dahl R, Dalal J, Alagappan VKT, et al. Efficacy and safety of QVA149 compared to the concurrent administration of its monocomponents indacaterol and glycopyrronium: the BEACON study. Int J COPD. 2013;8:501–8.CrossRef Dahl R, Dalal J, Alagappan VKT, et al. Efficacy and safety of QVA149 compared to the concurrent administration of its monocomponents indacaterol and glycopyrronium: the BEACON study. Int J COPD. 2013;8:501–8.CrossRef
7.
go back to reference Donohue JF, Fogarty C, Lötvall J, et al. Once-daily bronchodilators for chronic obstructive pulmonary disease: indacaterol versus tiotropium. Am J Respir Crit Care Med. 2010;182(2):155–62.CrossRefPubMed Donohue JF, Fogarty C, Lötvall J, et al. Once-daily bronchodilators for chronic obstructive pulmonary disease: indacaterol versus tiotropium. Am J Respir Crit Care Med. 2010;182(2):155–62.CrossRefPubMed
8.
go back to reference Dahl R, Chung KF, Buhl R, et al. Efficacy of a new once-daily long-acting inhaled β2-agonist indacaterol versus twice-daily formoterol in COPD. Thorax. 2010;65(6):473–9.CrossRefPubMed Dahl R, Chung KF, Buhl R, et al. Efficacy of a new once-daily long-acting inhaled β2-agonist indacaterol versus twice-daily formoterol in COPD. Thorax. 2010;65(6):473–9.CrossRefPubMed
10.
go back to reference Kornmann O, Dahl R, Centanni S, et al. Once-daily indacaterol versus twice-daily salmeterol for COPD: a placebo-controlled comparison. Eur Respir J. 2011;37(2):273–9.CrossRefPubMed Kornmann O, Dahl R, Centanni S, et al. Once-daily indacaterol versus twice-daily salmeterol for COPD: a placebo-controlled comparison. Eur Respir J. 2011;37(2):273–9.CrossRefPubMed
11.
go back to reference Korn S, Kerwin E, Atis S, et al. Indacaterol once daily provides superior efficacy to salmeterol twice daily in COPD: a 12-week study. Respir Med. 2011;105(5):719–26.CrossRefPubMed Korn S, Kerwin E, Atis S, et al. Indacaterol once daily provides superior efficacy to salmeterol twice daily in COPD: a 12-week study. Respir Med. 2011;105(5):719–26.CrossRefPubMed
12.
go back to reference Buhl R, Dunn LJ, Disdier C, et al. Blinded 12-week comparison of once-daily indacaterol and tiotropium in COPD. Eur Respir J. 2011;38(4):797–803.CrossRefPubMed Buhl R, Dunn LJ, Disdier C, et al. Blinded 12-week comparison of once-daily indacaterol and tiotropium in COPD. Eur Respir J. 2011;38(4):797–803.CrossRefPubMed
13.
go back to reference DeCramer ML, Chapman KR, Dahl R, et al. Once-daily indacaterol versus tiotropium for patients with severe chronic obstructive pulmonary disease (INVIGORATE): a randomised, blinded, parallel-group study. Lancet Respir Med. 2013;1(7):524–33. DeCramer ML, Chapman KR, Dahl R, et al. Once-daily indacaterol versus tiotropium for patients with severe chronic obstructive pulmonary disease (INVIGORATE): a randomised, blinded, parallel-group study. Lancet Respir Med. 2013;1(7):524–33.
14.
go back to reference Chapman KR, Rennard SI, Dogra A, et al. Long-term safety and efficacy of indacaterol, a long-acting β2-agonist, in subjects with COPD: a randomized, placebo-controlled study. Chest. 2011;140(1):68–75.CrossRefPubMed Chapman KR, Rennard SI, Dogra A, et al. Long-term safety and efficacy of indacaterol, a long-acting β2-agonist, in subjects with COPD: a randomized, placebo-controlled study. Chest. 2011;140(1):68–75.CrossRefPubMed
15.
go back to reference Pascoe S, Reynolds C, Pleskow W, et al. Safety, tolerability and pharmacokinetics of single escalating doses of indacaterol, a once-daily beta2-agonist bronchodilator, in subjects with COPD. Int J Clin Pharmacol Ther. 2011;49(2):153–61.CrossRefPubMed Pascoe S, Reynolds C, Pleskow W, et al. Safety, tolerability and pharmacokinetics of single escalating doses of indacaterol, a once-daily beta2-agonist bronchodilator, in subjects with COPD. Int J Clin Pharmacol Ther. 2011;49(2):153–61.CrossRefPubMed
16.
go back to reference Sykes DA, Dowling MR, Leighton-Davies J, et al. The influence of receptor kinetics on the onset and duration of action and the therapeutic index of NVA237 and tiotropium. J Pharmacol Exp Ther. 2012;343(2):520–8.CrossRefPubMed Sykes DA, Dowling MR, Leighton-Davies J, et al. The influence of receptor kinetics on the onset and duration of action and the therapeutic index of NVA237 and tiotropium. J Pharmacol Exp Ther. 2012;343(2):520–8.CrossRefPubMed
18.
go back to reference 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):1106–14.PubMedCentralCrossRefPubMed 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):1106–14.PubMedCentralCrossRefPubMed
19.
go back to reference Drollmann A, Brown M, Sechaud R, et al. Effect of once-daily QVA149 on cardiac safety in healthy volunteers [abstract no. F64]. American Thoracic Society 109th international conference; 17–22 May 2013; Philadelphia (PA). Drollmann A, Brown M, Sechaud R, et al. Effect of once-daily QVA149 on cardiac safety in healthy volunteers [abstract no. F64]. American Thoracic Society 109th international conference; 17–22 May 2013; Philadelphia (PA).
20.
go back to reference Van de Maele B, Fabbri LM, Martin C, et al. Cardiovascular safety of QVA149, a combination of indacaterol and NVA237. COPD patients. COPD. 2010;7(6):418–27.CrossRefPubMed Van de Maele B, Fabbri LM, Martin C, et al. Cardiovascular safety of QVA149, a combination of indacaterol and NVA237. COPD patients. COPD. 2010;7(6):418–27.CrossRefPubMed
21.
go back to reference Cazzola M, Calzetta L, Page CP, et al. Use of indacaterol for the treatment of COPD: a pharmacokinetic evaluation. Expert Opin Drug Metab Toxicol. 2014;10(1):129–37.CrossRefPubMed Cazzola M, Calzetta L, Page CP, et al. Use of indacaterol for the treatment of COPD: a pharmacokinetic evaluation. Expert Opin Drug Metab Toxicol. 2014;10(1):129–37.CrossRefPubMed
23.
go back to reference Asai K, Minakata Y, Hirata K, et al. Once-daily QVA149 is safe and well tolerated and improves lung function and health status in Japanese patients with COPD: the ARISE study [poster]. European Respiratory Society 23rd Annual Congress; 7–11 Sep 2013; Barcelona. Asai K, Minakata Y, Hirata K, et al. Once-daily QVA149 is safe and well tolerated and improves lung function and health status in Japanese patients with COPD: the ARISE study [poster]. European Respiratory Society 23rd Annual Congress; 7–11 Sep 2013; Barcelona.
24.
go back to reference Novartis Pharmaceuticals. Long term safety and tolerability of QVA149 versus tiotropium in Japanese patients with chronic obstructive pulmonary disease (COPD) (ARISE) [ClinicalTrials.gov identifier NCT01285492]. US National Institutes of Health, ClinicalTrials.gov [online]. 2013. http://clinicaltrials.gov/show/NCT01285492. Accessed 9 Oct 2013. Novartis Pharmaceuticals. Long term safety and tolerability of QVA149 versus tiotropium in Japanese patients with chronic obstructive pulmonary disease (COPD) (ARISE) [ClinicalTrials.gov identifier NCT01285492]. US National Institutes of Health, ClinicalTrials.gov [online]. 2013. http://​clinicaltrials.​gov/​show/​NCT01285492. Accessed 9 Oct 2013.
25.
26.
go back to reference Mahler DA, Decramer M, D’Urzo AD, 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 [abstract P236 plus oral presentation]. American Thoracic Society 109th international conference; 17–22 May 2013; Philadelphia (PA). Mahler DA, Decramer M, D’Urzo AD, 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 [abstract P236 plus oral presentation]. American Thoracic Society 109th international conference; 17–22 May 2013; Philadelphia (PA).
28.
go back to reference Novartis Pharmaceuticals. Effect of QVA149 on exercise tolerance in patients with chronic obstructive pulmonary disease (COPD) (BRIGHT) [ClinicalTrials.gov identifier NCT01294787]. US National Institutes of Health, ClinicalTrials.gov [online]. 2013. http://clinicaltrials.gov/show/NCT01294787. Accessed 9 Oct 2013. Novartis Pharmaceuticals. Effect of QVA149 on exercise tolerance in patients with chronic obstructive pulmonary disease (COPD) (BRIGHT) [ClinicalTrials.gov identifier NCT01294787]. US National Institutes of Health, ClinicalTrials.gov [online]. 2013. http://​clinicaltrials.​gov/​show/​NCT01294787. Accessed 9 Oct 2013.
29.
go back to reference 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):1558–67.CrossRefPubMed 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):1558–67.CrossRefPubMed
30.
go back to reference Banerji D, Alagappan V, Green Y, et al. Dual bronchodilation with once-daily QVA149 improves dyspnoea and health status and reduces symptoms and rescue medication use in patients with COPD: the IGNITE trials [poster]. European Respiratory Society 23rd Annual Congress; 7–11 Sep 2013; Barcelona. Banerji D, Alagappan V, Green Y, et al. Dual bronchodilation with once-daily QVA149 improves dyspnoea and health status and reduces symptoms and rescue medication use in patients with COPD: the IGNITE trials [poster]. European Respiratory Society 23rd Annual Congress; 7–11 Sep 2013; Barcelona.
31.
go back to reference Novartis Pharmaceuticals. A 52-week treatment, multi-center, randomized, double-blind, double dummy, parallel-group, active controlled study to compare the effect of QVA149 (indacaterol maleate/glycopyrronium bromide) with salmeterol/fluticasone on the rate of exacerbations in subjects with moderate to very severe COPD (FLAME) [ClinicalTrials.gov identifier NCT01782326]. US National Institutes of Health, ClinicalTrials.gov [online]. 2013. http://clinicaltrials.gov/show/NCT01782326. Accessed 9 Oct 2013. Novartis Pharmaceuticals. A 52-week treatment, multi-center, randomized, double-blind, double dummy, parallel-group, active controlled study to compare the effect of QVA149 (indacaterol maleate/glycopyrronium bromide) with salmeterol/fluticasone on the rate of exacerbations in subjects with moderate to very severe COPD (FLAME) [ClinicalTrials.gov identifier NCT01782326]. US National Institutes of Health, ClinicalTrials.gov [online]. 2013. http://​clinicaltrials.​gov/​show/​NCT01782326. Accessed 9 Oct 2013.
32.
go back to reference 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 Respir Med. 2013;1(1):51–60.CrossRefPubMed 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 Respir Med. 2013;1(1):51–60.CrossRefPubMed
33.
go back to reference Bateman ED, Vogelmeier C, Pallante J, et al. Once-daily QVA149 improves breathlessness and reduces rescue medication use compared to twice-daily salmeterol/fluticasone in patients with COPD: the ILLUMINATE study [abstract no. 807]. American Thoracic Society 109th international conference; 17–22 May 2013; Philadelphia (PA). Bateman ED, Vogelmeier C, Pallante J, et al. Once-daily QVA149 improves breathlessness and reduces rescue medication use compared to twice-daily salmeterol/fluticasone in patients with COPD: the ILLUMINATE study [abstract no. 807]. American Thoracic Society 109th international conference; 17–22 May 2013; Philadelphia (PA).
34.
go back to reference Dahl R, Gallagher N, Green Y, et al. QVA149 provides a rapid onset of action which is sustained throughout treatment in patients with COPD [poster]. European Respiratory Society 23rd Annual Congress; 7–11 Sep 2013; Barcelona. Dahl R, Gallagher N, Green Y, et al. QVA149 provides a rapid onset of action which is sustained throughout treatment in patients with COPD [poster]. European Respiratory Society 23rd Annual Congress; 7–11 Sep 2013; Barcelona.
35.
go back to reference Vogelmeier C, Dahl R, D’Urzo A, et al. Once-daily QVA149 provides clinically meaningful improvements in lung function and clinical outcomes [poster]. European Respiratory Society 23rd Annual Congress; 7–11 Sep 2013; Barcelona. Vogelmeier C, Dahl R, D’Urzo A, et al. Once-daily QVA149 provides clinically meaningful improvements in lung function and clinical outcomes [poster]. European Respiratory Society 23rd Annual Congress; 7–11 Sep 2013; Barcelona.
36.
go back to reference Barnes N, Hashimoto S, Nagase T, et al. QVA149 provides superior peak lung function in patients with COPD [poster]. European Respiratory Society 23rd Annual Congress; 7–11 Sep 2013; Barcelona. Barnes N, Hashimoto S, Nagase T, et al. QVA149 provides superior peak lung function in patients with COPD [poster]. European Respiratory Society 23rd Annual Congress; 7–11 Sep 2013; Barcelona.
37.
go back to reference Gallagher N, Alagappan V, Green Y, et al. Dual bronchodilation with once-daily QVA149 improves lung function and reduces exacerbations in patients with COPD: the IGNITE trials [poster]. European Respiratory Society 23rd Annual Congress; 7–11 Sep 2013; Barcelona. Gallagher N, Alagappan V, Green Y, et al. Dual bronchodilation with once-daily QVA149 improves lung function and reduces exacerbations in patients with COPD: the IGNITE trials [poster]. European Respiratory Society 23rd Annual Congress; 7–11 Sep 2013; Barcelona.
38.
go back to reference Welte T, Dahl R, Chen H, et al. Once-daily QVA149 improves symptom scores in patients with COPD [poster]. European Respiratory Society 23rd Annual Congress; 7–11 Sep 2013; Barcelona. Welte T, Dahl R, Chen H, et al. Once-daily QVA149 improves symptom scores in patients with COPD [poster]. European Respiratory Society 23rd Annual Congress; 7–11 Sep 2013; Barcelona.
39.
go back to reference Novartis Pharmaceuticals. A 26-week treatment randomized, double-blind, double dummy, parallel-group study to assess the efficacy, safety and tolerability of QVA149 (indacaterol/glycopyrronium bromide) compared to fluticasone/salmeterol in patients with moderate to severe chronic obstructive pulmonary disease [ClinicalTrials.gov identifier NCT01709903]. US National Institutes of Health, ClinicalTrials.gov [online]. 2013. http://clinicaltrials.gov/show/NCT01709903. Accessed 9 Oct 2013. Novartis Pharmaceuticals. A 26-week treatment randomized, double-blind, double dummy, parallel-group study to assess the efficacy, safety and tolerability of QVA149 (indacaterol/glycopyrronium bromide) compared to fluticasone/salmeterol in patients with moderate to severe chronic obstructive pulmonary disease [ClinicalTrials.gov identifier NCT01709903]. US National Institutes of Health, ClinicalTrials.gov [online]. 2013. http://​clinicaltrials.​gov/​show/​NCT01709903. Accessed 9 Oct 2013.
40.
go back to reference Novartis Pharmaceuticals. Comparison of long-term safety of the combination product QVA149A against placebo and standard of care treatment in chronic obstructive pulmonary disease patients with moderate to severe airflow limitation (RADIATE) [ClinicalTrials.gov identifier NCT01610037]. US National Institutes of Health, ClinicalTrials.gov [online]. 2013. http://clinicaltrials.gov/show/NCT01610037. Accessed 9 Oct 2013. Novartis Pharmaceuticals. Comparison of long-term safety of the combination product QVA149A against placebo and standard of care treatment in chronic obstructive pulmonary disease patients with moderate to severe airflow limitation (RADIATE) [ClinicalTrials.gov identifier NCT01610037]. US National Institutes of Health, ClinicalTrials.gov [online]. 2013. http://​clinicaltrials.​gov/​show/​NCT01610037. Accessed 9 Oct 2013.
41.
go back to reference Bateman ED, Ferguson GT, Barnes N, et al. Dual bronchodilation with QVA149 versus single bronchodilator therapy: the SHINE study. Eur Respir J. 2013;42(6):1484–94. Bateman ED, Ferguson GT, Barnes N, et al. Dual bronchodilation with QVA149 versus single bronchodilator therapy: the SHINE study. Eur Respir J. 2013;42(6):1484–94.
42.
go back to reference Welte T, Gallagher N, Green Y, et al. Dual bronchodilation with once-daily QVA149 provides significantly improved clinical outcomes versus mono-bronchodilator therapy: the SHINE study [abstract no. G25]. American Thoracic Society 109th international conference; 17–22 May 2013; Philadelphia (PA). Welte T, Gallagher N, Green Y, et al. Dual bronchodilation with once-daily QVA149 provides significantly improved clinical outcomes versus mono-bronchodilator therapy: the SHINE study [abstract no. G25]. American Thoracic Society 109th international conference; 17–22 May 2013; Philadelphia (PA).
43.
go back to reference Bateman ED, Ferguson GT, Welte T, et al. Dual bronchodilation with once-daily QVA149 significantly improves lung function versus single bronchodilators and salmeterol/fluticasone [abstract no. G30]. American Thoracic Society 109th international conference; 17–22 May 2013; Philadelphia (PA). Bateman ED, Ferguson GT, Welte T, et al. Dual bronchodilation with once-daily QVA149 significantly improves lung function versus single bronchodilators and salmeterol/fluticasone [abstract no. G30]. American Thoracic Society 109th international conference; 17–22 May 2013; Philadelphia (PA).
44.
go back to reference Wedzicha JA, Decramer M, Ficker JH, et al. Analysis of chronic obstructive pulmonary disease exacerbations with the dual bronchodilator QVA149 compared with glycopyrronium and tiotropium (SPARK): a randomised, double-blind, parallel-group study. Lancet Respir Med. 2013;1(3):199–209.CrossRefPubMed Wedzicha JA, Decramer M, Ficker JH, et al. Analysis of chronic obstructive pulmonary disease exacerbations with the dual bronchodilator QVA149 compared with glycopyrronium and tiotropium (SPARK): a randomised, double-blind, parallel-group study. Lancet Respir Med. 2013;1(3):199–209.CrossRefPubMed
45.
go back to reference Ficker J, Wedzicha JA, Decramer M, et al. QVA149 improves lung function and reduces exacerbations compared to tiotropium in patients with severe-to-very severe COPD: the SPARK study [poster]. European Respiratory Society 23rd Annual Congress; 7–11 Sep 2013; Barcelona. Ficker J, Wedzicha JA, Decramer M, et al. QVA149 improves lung function and reduces exacerbations compared to tiotropium in patients with severe-to-very severe COPD: the SPARK study [poster]. European Respiratory Society 23rd Annual Congress; 7–11 Sep 2013; Barcelona.
46.
go back to reference Banerji D, Fowler Taylor A, Kho P, et al. Once-daily QVA149 provides superior improvements in lung function compared with glycopyrronium and tiotropium in severe COPD patients: a 52 week pooled analysis [poster]. European Respiratory Society 23rd Annual Congress; 7–11 Sep 2013; Barcelona. Banerji D, Fowler Taylor A, Kho P, et al. Once-daily QVA149 provides superior improvements in lung function compared with glycopyrronium and tiotropium in severe COPD patients: a 52 week pooled analysis [poster]. European Respiratory Society 23rd Annual Congress; 7–11 Sep 2013; Barcelona.
47.
go back to reference Wedzicha JA, Decramer M, Vestbo J, et al. A novel study design for the comparison between once-daily QVA149 and twice-daily salmeterol/fluticasone on the reduction of COPD exacerbations: the FLAME study [poster]. European Respiratory Society 23rd Annual Congress; 7–11 Sep 2013; Barcelona. Wedzicha JA, Decramer M, Vestbo J, et al. A novel study design for the comparison between once-daily QVA149 and twice-daily salmeterol/fluticasone on the reduction of COPD exacerbations: the FLAME study [poster]. European Respiratory Society 23rd Annual Congress; 7–11 Sep 2013; Barcelona.
48.
49.
go back to reference Cazzola M, MacNee W, Martinez FJ, et al. Outcomes for COPD pharmacological trials: from lung function to biomarkers. Eur Respir J. 2008;31(2):416–69.CrossRefPubMed Cazzola M, MacNee W, Martinez FJ, et al. Outcomes for COPD pharmacological trials: from lung function to biomarkers. Eur Respir J. 2008;31(2):416–69.CrossRefPubMed
50.
go back to reference Jones PW, Beeh KM, Chapman KR, et al. Minimal clinically important differences in pharmacological trials. Am J Respir Crit Care Med. 2014;189(3):250–5.CrossRefPubMed Jones PW, Beeh KM, Chapman KR, et al. Minimal clinically important differences in pharmacological trials. Am J Respir Crit Care Med. 2014;189(3):250–5.CrossRefPubMed
51.
go back to reference Mahler DA, Witek TJ Jr. The MCID of the transition dyspnea index is a total score of one unit. COPD. 2005;2(1):99–103.CrossRefPubMed Mahler DA, Witek TJ Jr. The MCID of the transition dyspnea index is a total score of one unit. COPD. 2005;2(1):99–103.CrossRefPubMed
53.
go back to reference Welte T, Vogelmeier C, Dahl R, et al. Once-daily QVA149 has a good safety profile in patients with COPD [poster]. European Respiratory Society 23rd Annual Congress; 7–11 Sep 2013; Barcelona. Welte T, Vogelmeier C, Dahl R, et al. Once-daily QVA149 has a good safety profile in patients with COPD [poster]. European Respiratory Society 23rd Annual Congress; 7–11 Sep 2013; Barcelona.
54.
go back to reference Ferguson GT, Barnes N, Mehta R, et al. Cardio- and cerebro-vascular safety of QVA149: results from a pooled analysis [poster]. European Respiratory Society 23rd Annual Congress; 7–11 Sep 2013; Barcelona. Ferguson GT, Barnes N, Mehta R, et al. Cardio- and cerebro-vascular safety of QVA149: results from a pooled analysis [poster]. European Respiratory Society 23rd Annual Congress; 7–11 Sep 2013; Barcelona.
55.
go back to reference Chen H, D’Andrea P, Banerji D. QVA149 does not increase the risk of cardio- and cerebro-vascular events, pneumonia and exacerbation events compared with placebo: a network meta-analysis across multiple safety databases [poster]. European Respiratory Society 23rd Annual Congress; 7–11 Sep 2013; Barcelona. Chen H, D’Andrea P, Banerji D. QVA149 does not increase the risk of cardio- and cerebro-vascular events, pneumonia and exacerbation events compared with placebo: a network meta-analysis across multiple safety databases [poster]. European Respiratory Society 23rd Annual Congress; 7–11 Sep 2013; Barcelona.
56.
go back to reference Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease (updated 2014). http://www.goldcopd.org/. Accessed 30 Jan 2014. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease (updated 2014). http://​www.​goldcopd.​org/​. Accessed 30 Jan 2014.
57.
go back to reference Gladysheva ES, Malhotra A, Owens RL. Influencing the decline of lung function in COPD: use of pharmacotherapy. Int J COPD. 2010;5:153–64. Gladysheva ES, Malhotra A, Owens RL. Influencing the decline of lung function in COPD: use of pharmacotherapy. Int J COPD. 2010;5:153–64.
58.
go back to reference Lemmens V, Oenema A, Knut IK, et al. Effectiveness of smoking cessation interventions among adults: a systematic review of reviews. Eur J Cancer Prev. 2008;17(6):535–44.CrossRefPubMed Lemmens V, Oenema A, Knut IK, et al. Effectiveness of smoking cessation interventions among adults: a systematic review of reviews. Eur J Cancer Prev. 2008;17(6):535–44.CrossRefPubMed
60.
go back to reference Qaseem A, Wilt TJ, Weinberger SE, et al. Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann Intern Med. 2011;155:179–91.CrossRefPubMed Qaseem A, Wilt TJ, Weinberger SE, et al. Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann Intern Med. 2011;155:179–91.CrossRefPubMed
62.
go back to reference Spina D. Current and novel bronchodilators in respiratory disease. Curr Opin Pulm Med. 2014;20(1):73–86.CrossRefPubMed Spina D. Current and novel bronchodilators in respiratory disease. Curr Opin Pulm Med. 2014;20(1):73–86.CrossRefPubMed
63.
64.
go back to reference Montuschi P. Pharmacological treatment of chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2006;1(4):409–23.PubMedCentralPubMed Montuschi P. Pharmacological treatment of chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2006;1(4):409–23.PubMedCentralPubMed
67.
go back to reference Jacobsen JR, Choi SK, Combs J, et al. A multivalent approach to the discovery of long-acting β(2)-adrenoceptor agonists for the treatment of asthma and COPD. Bioorg Med Chem Lett. 2012;22(2):1213–8.CrossRefPubMed Jacobsen JR, Choi SK, Combs J, et al. A multivalent approach to the discovery of long-acting β(2)-adrenoceptor agonists for the treatment of asthma and COPD. Bioorg Med Chem Lett. 2012;22(2):1213–8.CrossRefPubMed
68.
go back to reference Bateman ED, Make BJ, Nandeuil MA. Safety and tolerability of a long-acting beta2-agonist in patients with COPD [abstract]. Am J Respir Crit Care Med. 2008;177:A653. Bateman ED, Make BJ, Nandeuil MA. Safety and tolerability of a long-acting beta2-agonist in patients with COPD [abstract]. Am J Respir Crit Care Med. 2008;177:A653.
69.
go back to reference Aparici M, Gómez-Angelats M, Vilella D, et al. Pharmacological characterization of abediterol, a novel inhaled β(2)-adrenoceptor agonist with long duration of action and a favourable safety profile in preclinical models. J Pharmacol Exp Ther. 2012;342(2):497–509.CrossRefPubMed Aparici M, Gómez-Angelats M, Vilella D, et al. Pharmacological characterization of abediterol, a novel inhaled β(2)-adrenoceptor agonist with long duration of action and a favourable safety profile in preclinical models. J Pharmacol Exp Ther. 2012;342(2):497–509.CrossRefPubMed
70.
go back to reference Fuso L, Mores N, Valente S, et al. Long-acting beta-agonists and their association with inhaled corticosteroids in COPD. Curr Med Chem. 2013;20(12):1477–95.CrossRefPubMed Fuso L, Mores N, Valente S, et al. Long-acting beta-agonists and their association with inhaled corticosteroids in COPD. Curr Med Chem. 2013;20(12):1477–95.CrossRefPubMed
71.
go back to reference Woods JA, Nealy KL, Barrons RW. Aclidinium bromide: an alternative long-acting inhaled anticholinergic in the management of chronic obstructive pulmonary disease. Ann Pharmacother. 2013;47(7–8):1017–28.CrossRefPubMed Woods JA, Nealy KL, Barrons RW. Aclidinium bromide: an alternative long-acting inhaled anticholinergic in the management of chronic obstructive pulmonary disease. Ann Pharmacother. 2013;47(7–8):1017–28.CrossRefPubMed
72.
go back to reference Keam SJ, Keating GM. Tiotropium bromide. A review of its use as maintenance therapy in patients with COPD. Treat Respir Med. 2004;3(4):247–68.CrossRefPubMed Keam SJ, Keating GM. Tiotropium bromide. A review of its use as maintenance therapy in patients with COPD. Treat Respir Med. 2004;3(4):247–68.CrossRefPubMed
73.
go back to reference Salmon M, Luttmann MA, Foley JJ, et al. Pharmacological characterization of GSK573719 (umeclidinium): a novel, long-acting, inhaled antagonist of the muscarinic cholinergic receptors for treatment of pulmonary diseases. J Pharmacol Exp Ther. 2013;345(2):260–70.CrossRefPubMed Salmon M, Luttmann MA, Foley JJ, et al. Pharmacological characterization of GSK573719 (umeclidinium): a novel, long-acting, inhaled antagonist of the muscarinic cholinergic receptors for treatment of pulmonary diseases. J Pharmacol Exp Ther. 2013;345(2):260–70.CrossRefPubMed
77.
go back to reference Meurs H, Dekkers BG, Maarsingh H, et al. Muscarinic receptors on airway mesenchymal cells: novel findings for an ancient target. Pulm Pharmacol Ther. 2013;26(1):145–55.CrossRefPubMed Meurs H, Dekkers BG, Maarsingh H, et al. Muscarinic receptors on airway mesenchymal cells: novel findings for an ancient target. Pulm Pharmacol Ther. 2013;26(1):145–55.CrossRefPubMed
78.
go back to reference Pera T, Zuidhof A, Valadas J, et al. Tiotropium inhibits pulmonary inflammation and remodelling in a guinea pig model of COPD. Eur Respir J. 2011;38:789–96.CrossRefPubMed Pera T, Zuidhof A, Valadas J, et al. Tiotropium inhibits pulmonary inflammation and remodelling in a guinea pig model of COPD. Eur Respir J. 2011;38:789–96.CrossRefPubMed
79.
go back to reference 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):486–96. 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):486–96.
80.
go back to reference Toy EL, Beaulieu NU, McHale JM, et al. Treatment of COPD: relationships between daily dosing frequency, adherence, resource use, and costs. Respir Med. 2011;105(3):435–41.CrossRefPubMed Toy EL, Beaulieu NU, McHale JM, et al. Treatment of COPD: relationships between daily dosing frequency, adherence, resource use, and costs. Respir Med. 2011;105(3):435–41.CrossRefPubMed
81.
go back to reference Roche N, Chanez P. Bronchodilator combinations for COPD: real hopes or a new Pandora’s box? Eur Respir J. 2013;42:1441–5.CrossRefPubMed Roche N, Chanez P. Bronchodilator combinations for COPD: real hopes or a new Pandora’s box? Eur Respir J. 2013;42:1441–5.CrossRefPubMed
82.
go back to reference Schachter EN. Indacaterol/glycopyrronium bromide fixed-dose combination for the treatment of COPD. Drugs Today (Barc). 2013;49(7):437–46. Schachter EN. Indacaterol/glycopyrronium bromide fixed-dose combination for the treatment of COPD. Drugs Today (Barc). 2013;49(7):437–46.
85.
go back to reference Cazzola M, Page C, Matera MG. Long-acting muscarinic receptor antagonists for the treatment of respiratory disease. Pulm Pharmacol Ther. 2013;26(3):307–17.CrossRefPubMed Cazzola M, Page C, Matera MG. Long-acting muscarinic receptor antagonists for the treatment of respiratory disease. Pulm Pharmacol Ther. 2013;26(3):307–17.CrossRefPubMed
86.
go back to reference Dransfield MT, Bourbeau J, Jones PW, et al. Once-daily inhaled fluticasone furoate and vilanterol versus vilanterol only for prevention of exacerbations of COPD: two replicate double-blind, parallel-group, randomized controlled trials. Lancet Respir Med. 2013;1(3):210–23.CrossRefPubMed Dransfield MT, Bourbeau J, Jones PW, et al. Once-daily inhaled fluticasone furoate and vilanterol versus vilanterol only for prevention of exacerbations of COPD: two replicate double-blind, parallel-group, randomized controlled trials. Lancet Respir Med. 2013;1(3):210–23.CrossRefPubMed
87.
go back to reference Cyr M-C, Beauchesne M-F, Lemière C, et al. Effects of inhaled corticosteroids in monotherapy or combined with long-acting β2-agonists on mortality among patients with chronic obstructive pulmonary disease. Ann Pharmacother. 2010;44(4):613–22.CrossRefPubMed Cyr M-C, Beauchesne M-F, Lemière C, et al. Effects of inhaled corticosteroids in monotherapy or combined with long-acting β2-agonists on mortality among patients with chronic obstructive pulmonary disease. Ann Pharmacother. 2010;44(4):613–22.CrossRefPubMed
90.
go back to reference Tashkin DP, Doherty DE, Kerwin E, et al. Efficacy and safety characteristics of mometasone furoate/formoterol fumarate fixed-dose combination in subjects with moderate to very severe COPD: findings from pooled analysis of two randomized, 52-week placebo-controlled trials. Int J COPD. 2012;7:73–86. Tashkin DP, Doherty DE, Kerwin E, et al. Efficacy and safety characteristics of mometasone furoate/formoterol fumarate fixed-dose combination in subjects with moderate to very severe COPD: findings from pooled analysis of two randomized, 52-week placebo-controlled trials. Int J COPD. 2012;7:73–86.
91.
go back to reference Fuso L, Mores N, Valente S, et al. Long-acting beta-agonists and their association with inhaled corticosteroids in COPD. Curr Med Chem. 2013;20(12):1477–95.CrossRefPubMed Fuso L, Mores N, Valente S, et al. Long-acting beta-agonists and their association with inhaled corticosteroids in COPD. Curr Med Chem. 2013;20(12):1477–95.CrossRefPubMed
92.
go back to reference Yang IA, Clarke MS, Sim EH, et al. Inhaled corticosteroids for stable chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2012;7:CD002991. Yang IA, Clarke MS, Sim EH, et al. Inhaled corticosteroids for stable chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2012;7:CD002991.
93.
go back to reference Nannini LJ, Lasserson TJ, Poole P. Combined corticosteroid and long-acting beta(2)-agonist in one inhaler versus long-acting beta(2)-agonists for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2012;9:CD006829. Nannini LJ, Lasserson TJ, Poole P. Combined corticosteroid and long-acting beta(2)-agonist in one inhaler versus long-acting beta(2)-agonists for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2012;9:CD006829.
94.
go back to reference Anton E. How and when to use inhaled corticosteroids in chronic obstructive pulmonary disease? Expert Rev Respir Med. 2013;7(Suppl 2):25–32.CrossRefPubMed Anton E. How and when to use inhaled corticosteroids in chronic obstructive pulmonary disease? Expert Rev Respir Med. 2013;7(Suppl 2):25–32.CrossRefPubMed
97.
go back to reference Rodrigo GJ, Nannini LJ, Rodriguez-Roisin R. Safety of long-acting beta-agonists in stable COPD: a systematic review. Chest. 2008;133(5):1079–87.CrossRefPubMed Rodrigo GJ, Nannini LJ, Rodriguez-Roisin R. Safety of long-acting beta-agonists in stable COPD: a systematic review. Chest. 2008;133(5):1079–87.CrossRefPubMed
98.
go back to reference Wise RA, Anzueto A, Cotton D, et al. Tiotropium Respimat inhaler and the risk of death in COPD. New Engl J Med. 2013;369:1491–501.CrossRefPubMed Wise RA, Anzueto A, Cotton D, et al. Tiotropium Respimat inhaler and the risk of death in COPD. New Engl J Med. 2013;369:1491–501.CrossRefPubMed
99.
go back to reference Rutten-van Mölken MP. Goossens M. Cost effectiveness of pharmacological maintenance treatment for chronic obstructive pulmonary disease: a review of the evidence and methodological issues. Pharmacoeconomics. 2012;30(4):271–302.CrossRefPubMed Rutten-van Mölken MP. Goossens M. Cost effectiveness of pharmacological maintenance treatment for chronic obstructive pulmonary disease: a review of the evidence and methodological issues. Pharmacoeconomics. 2012;30(4):271–302.CrossRefPubMed
100.
go back to reference Najafzadeh M, Marra CA, Sadatsafavi M, et al. Cost effectiveness of therapy with combinations of long acting bronchodilators and inhaled steroids for treatment of COPD. Thorax. 2008;63:962–7.CrossRefPubMed Najafzadeh M, Marra CA, Sadatsafavi M, et al. Cost effectiveness of therapy with combinations of long acting bronchodilators and inhaled steroids for treatment of COPD. Thorax. 2008;63:962–7.CrossRefPubMed
Metadata
Title
QVA149 (Indacaterol/Glycopyrronium Fixed-Dose Combination): A Review of Its Use in Patients with Chronic Obstructive Pulmonary Disease
Author
James E. Frampton
Publication date
01-03-2014
Publisher
Springer International Publishing
Published in
Drugs / Issue 4/2014
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-014-0194-8

Other articles of this Issue 4/2014

Drugs 4/2014 Go to the issue