New combination bronchodilators for chronic obstructive pulmonary disease: Current evidence and future perspectives

British Journal of Clinical Pharmacology

Volumn 79, Issue 5, 2015, Pages 695-708

  Singh, Dave ^a  

^a UNIVERSITY OF MANCHESTER   (United Kingdom)

Author keywords

bronchodilators; COPD; fixed dose combinations; QVA149; umeclidinium; vilanterol

Indexed keywords

ACLIDINIUM BROMIDE PLUS FORMOTEROL FUMARATE; FLUTICASONE; GLYCOPYRRONIUM BROMIDE PLUS INDACATEROL; SALMETEROL; TIOTROPIUM BROMIDE; UMECLIDINIUM PLUS VILANTEROL; BETA 2 ADRENERGIC RECEPTOR STIMULATING AGENT; BRONCHODILATING AGENT; DELAYED RELEASE FORMULATION; DRUG COMBINATION; MUSCARINIC RECEPTOR BLOCKING AGENT;

ARTICLE; BRONCHODILATATION; CHRONIC OBSTRUCTIVE LUNG DISEASE; DRUG EFFICACY; DRUG SAFETY; DRY POWDER INHALER; FORCED EXPIRATORY VOLUME; HUMAN; LUNG FUNCTION; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; UNSPECIFIED SIDE EFFECT; DELAYED RELEASE FORMULATION; DOSE RESPONSE; DRUG COMBINATION; INHALATIONAL DRUG ADMINISTRATION; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; TREATMENT OUTCOME;

ADMINISTRATION, INHALATION; ADRENERGIC BETA-2 RECEPTOR AGONISTS; BRONCHODILATOR AGENTS; CLINICAL TRIALS, PHASE III AS TOPIC; DELAYED-ACTION PREPARATIONS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG COMBINATIONS; DRY POWDER INHALERS; HUMANS; MUSCARINIC ANTAGONISTS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; TREATMENT OUTCOME;

EID: 84928384173     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/bcp.12545     Document Type: Article

References (59)

1. Decramer M, Janssens W, Miravitlles M,. Chronic obstructive pulmonary disease. Lancet 2012; 379: 1341-1351.
2. Hogg JC, McDonough JE, Suzuki M,. Small airway obstruction in COPD: new insights based on micro-CT imaging and MRI imaging. Chest 2013; 143: 1436-1443.
3. GOLD. Global strategy for the diagnosis, management and prevention of COPD. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Updated 2014. Available at http://www.goldcopd.org/guidelines-global-strategy-for-diagnosis-management.html (last accessed 10 February 2014).
4. Qaseem A, Wilt TJ, Weinberger SE, Hanania NA, Criner G, van der Molen T, Marciniuk DD, Denberg T, Schunemann H, Wedzicha W, MacDonald R, Shekelle P, American College of P, American College of Chest P, American Thoracic S, European Respiratory S. Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice 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: 179-191.
5. NICE. Clinical guideline 101. Chronic obstructive pulmonary disease. Management of chronic obstructive pulmonary disease in adults in primary and secondary care (partial update issued June 2010). National Institute for Health and Clinical Excellence. 2010. Available at http://www.nice.org.uk/guidance/cg101 (last accessed 24 January 2014).
6. O'Reilly J, Jones MM, Parnham J, Lovibond K, Rudolf M, Guideline Development G. Management of stable chronic obstructive pulmonary disease in primary and secondary care: summary of updated NICE guidance. BMJ 2010; 340: c3134.
7. Ball DI, Brittain RT, Coleman RA, Denyer LH, Jack D, Johnson M, Lunts LH, Nials AT, Sheldrick KE, Skidmore IF,. Salmeterol, a novel, long-acting beta 2-adrenoceptor agonist: characterization of pharmacological activity in vitro and in vivo. Br J Pharmacol 1991; 104: 665-671.
8. Casarosa P, Bouyssou T, Germeyer S, Schnapp A, Gantner F, Pieper M,. Preclinical evaluation of long-acting muscarinic antagonists: comparison of tiotropium and investigational drugs. J Pharmacol Exp Ther 2009; 330: 660-668.
9. Borrill ZL, Houghton CM, Woodcock AA, Vestbo J, Singh D,. Measuring bronchodilation in COPD clinical trials. Br J Clin Pharmacol 2005; 59: 379-384.
10. Renard D, Looby M, Kramer B, Lawrence D, Morris D, Stanski DR,. Characterization of the bronchodilatory dose response to indacaterol in patients with chronic obstructive pulmonary disease using model-based approaches. Respir Res 2011; 12: 54.
11. Rennard S, Bantje T, Centanni S, Chanez P, Chuchalin A, D'Urzo A, Kornmann O, Perry S, Jack D, Owen R, Higgins M,. A dose-ranging study of indacaterol in obstructive airways disease, with a tiotropium comparison. Respir Med 2008; 102: 1033-1044.
12. Singh D, Magnussen H, Kirsten A, Mindt S, Caracta C, Seoane B, Jarreta D, Garcia Gil E,. A randomised, placebo- and active-controlled dose-finding study of aclidinium bromide administered twice a day in COPD patients. Pulm Pharmacol Ther 2012; 25: 248-253.
13. Cazzola M, Page CP, Calzetta L, Matera MG,. Pharmacology and therapeutics of bronchodilators. Pharmacol Rev 2012; 64: 450-504.
14. Combivent® (ipratropium bromide and albuterol sulfate) Inhalation Aerosol Prescribing Information (Boehringer Ingelheim, 2012). Available at http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/Combivent+Respimat/CMVTRSPT.pdf (last accessed 31 January 2014).
15. Hanania NA, Boota A, Kerwin E, Tomlinson L, Denis-Mize K,. Efficacy and safety of nebulized formoterol as add-on therapy in COPD patients receiving maintenance tiotropium bromide: results from a 6-week, randomized, placebo-controlled, clinical trial. Drugs 2009; 69: 1205-1216.
16. Tashkin DP, Littner M, Andrews CP, Tomlinson L, Rinehart M, Denis-Mize K,. Concomitant treatment with nebulized formoterol and tiotropium in subjects with COPD: a placebo-controlled trial. Respir Med 2008; 102: 479-487.
17. Tashkin DP, Pearle J, Iezzoni D, Varghese ST,. Formoterol and tiotropium compared with tiotropium alone for treatment of COPD. COPD 2009; 6: 17-25.
18. Terzano C, Petroianni A, Conti V, Ceccarelli D, Graziani E, Sanduzzi A, D'Avelli S,. Rational timing of combination therapy with tiotropium and formoterol in moderate and severe COPD. Respir Med 2008; 102: 1701-1707.
19. van Noord JA, Aumann JL, Janssens E, Verhaert J, Smeets JJ, Mueller A, Cornelissen PJ,. Effects of tiotropium with and without formoterol on airflow obstruction and resting hyperinflation in patients with COPD. Chest 2006; 129: 509-517.
20. Mahler D, D'Urzo A, Peckitt C, Lassen C, Kramer B, Filcek S,. Combining once-daily bronchodilators in COPD: indacaterol plus tiotropium versus tiotropium alone. Am J Respir Crit Care Med 2011; 183: A1591. Presented at the American Thoracic Society 2011 International Conference, Denver, CO. May 13-18, 2011.
21. Aaron SD, Vandemheen KL, Fergusson D, Maltais F, Bourbeau J, Goldstein R, Balter M, O'Donnell D, McIvor A, Sharma S, Bishop G, Anthony J, Cowie R, Field S, Hirsch A, Hernandez P, Rivington R, Road J, Hoffstein V, Hodder R, Marciniuk D, McCormack D, Fox G, Cox G, Prins HB, Ford G, Bleskie D, Doucette S, Mayers I, Chapman K, Zamel N, FitzGerald M, Canadian Thoracic Society/Canadian Respiratory Clinical Research C. Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial. Ann Intern Med 2007; 146: 545-555.
22. Tashkin DP, Donohue JF, Mahler DA, Huang H, Goodwin E, Schaefer K, Hanrahan JP, Andrews WT,. Effects of arformoterol twice daily, tiotropium once daily, and their combination in patients with COPD. Respir Med 2009; 103: 516-524.
23. van Noord JA, Aumann JL, Janssens E, Smeets JJ, Verhaert J, Disse B, Mueller A, Cornelissen PJ,. Comparison of tiotropium once daily, formoterol twice daily and both combined once daily in patients with COPD. Eur Respir J 2005; 26: 214-222.
24. van Noord JA, Aumann JL, Janssens E, Smeets JJ, Zaagsma J, Mueller A, Cornelissen PJ,. Combining tiotropium and salmeterol in COPD: effects on airflow obstruction and symptoms. Respir Med 2010; 104: 995-1004.
25. Vogelmeier C, Kardos P, Harari S, Gans SJ, Stenglein S, Thirlwell J,. Formoterol mono- and combination therapy with tiotropium in patients with COPD: a 6-month study. Respir Med 2008; 102: 1511-1520.
26. van Noord JA, Buhl R, Laforce C, Martin C, Jones F, Dolker M, Overend T,. QVA149 demonstrates superior bronchodilation compared with indacaterol or placebo in patients with chronic obstructive pulmonary disease. Thorax 2010; 65: 1086-1091.
27. Calverley PM, Burge PS, Spencer S, Anderson JA, Jones PW,. Bronchodilator reversibility testing in chronic obstructive pulmonary disease. Thorax 2003; 58: 659-664.
28. Cazzola M, Segreti A, Matera MG,. New developments in the combination treatment of COPD: focus on umeclidinium/vilanterol. Drug Des Devel Ther 2013; 7: 1201-1208.
29. Dahl R, Jadayel D, Alagappan VK, Chen H, Banerji D,. Efficacy and safety of QVA149 compared to the concurrent administration of its monocomponents indacaterol and glycopyrronium: the BEACON study. Int J Chron Obstruct Pulmon Dis 2013; 8: 501-508.
30. Bateman ED, Ferguson GT, Barnes N, Gallagher N, Green Y, Henley M, Banerji D,. Dual bronchodilation with QVA149 versus single bronchodilator therapy: the SHINE study. Eur Respir J 2013; 42: 1484-1494.
31. Mahler DA, Weinberg DH, Wells CK, Feinstein AR,. The measurement of dyspnea. Contents, interobserver agreement, and physiologic correlates of two new clinical indexes. Chest 1984; 85: 751-758.
32. Mahler DA, Witek TJ Jr,. The MCID of the transition dyspnea index is a total score of one unit. COPD 2005; 2: 99-103.
33. Wedzicha JA, Decramer M, Ficker JH, Niewoehner DE, Sandstrom T, Taylor AF, D'Andrea P, Arrasate C, Chen H, Banerji D,. 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: 199-209.
34. Mahler DA, Decramer M, D'Urzo A, Worth H, White T, Alagappan VK, Chen H, Gallagher N, Kulich K, Banerji D,. Dual bronchodilation with QVA149 reduces patient-reported dyspnoea in COPD: BLAZE study. Eur Respir J 2013; 43: 1599-1609.
35. Beeh KM, Horn S, Beier J, Jadayel D, Henley M, Tylek J, Berhane L, D'Andrea P, Banerji D,. QVA149 once-daily improves exercise tolerance and lung function in patients with COPD: the BRIGHT study. Thorax 2012; 67 (Suppl. 2): A147. Presented at the British Thoracic Society Winter Meeting 2012, London, December 5-7, 2012.
36. Vogelmeier CF, Bateman ED, Pallante J, Alagappan VK, D'Andrea P, Chen H, Banerji D,. 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: 51-60.
37. Roche N, Pribil C, Van Ganse E, Serrier P, Housset B, Poirier D, Texier N, Schück S, Boucot I,. Real-life use of fluticasone propionate/salmeterol in patients with chronic obstructive pulmonary disease: a French observational study. BMC Pulm Med 2014; 14: 56.
38. Donohue JF, Maleki-Yazdi MR, Kilbride S, Mehta R, Kalberg C, Church A,. Efficacy and safety of once-daily umeclidinium/vilanterol 62.5/25 mcg in COPD. Respir Med 2013; 107: 1538-1546.
39. Celli B, Crater G, Kilbride S, Mehta R, Tabberer M, Kalberg CJ, Church A,. Once-daily umeclidinium/vilanterol 125/25 mcg in COPD: a randomized, controlled study. Chest 2014; 145: 981-991.
40. Decramer M, Anzueto A, Kerwin E, Kaelin T, Richard N, Crater G, Tabberer M, Harris S, Church A,. 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: 472-486.
41. Almirall. Positive Phase III combo results from its 2nd study (aclidinium + formoterol). Press release May 2, 2013. Available at http://investors.almirall.es/phoenix.zhtml?c=209345&p=irol-newsArticle&ID=1814070&highlight (last accessed 28 February 2014).
42. D'Urzo A, Mergel V, Leselbaum A, Caracta C,. Efficacy and safety of fixed-dose combination aclidinium bromide/formoterol fumarate in patients with COPD: results from the AUGMENT COPD trial. Chest 2013; 144: 1025A. Presented at CHEST, Chicago, IL, October 26-31, 2013.
43. D'Urzo A, Rennard S, Mergel V, Garcia Gil E, Leselbaum A, Caracta C,. The AUGMENT COPD Trial: efficacy and safety of a fixed-dose combination of aclidinium bromide and formoterol fumarate in COPD patients. Chest 2014; 145: 426A. Presented at CHEST, Madrid, March 21-24, 2014.
44. Singh D, Jones P, Bateman E, Korn S, Serra C, Molins E, Caracta C, Garcia Gil E, Leselbaum A,. Evaluation of the efficacy and safety of two doses of aclidinium and formoterol in fixed-dose combination in patients with COPD: the ACLIFORM study. Chest 2014; 145: 375A. Presented at CHEST, Madrid, March 21-24, 2014.
45. Salpeter SR, Ormiston TM, Salpeter EE,. Cardiovascular effects of beta-agonists in patients with asthma and COPD: a meta-analysis. Chest 2004; 125: 2309-2321.
46. Cazzola M, Matera MG, Donner CF,. Inhaled beta2-adrenoceptor agonists: cardiovascular safety in patients with obstructive lung disease. Drugs 2005; 65: 1595-1610.
47. Gershon A, Croxford R, Calzavara A, To T, Stanbrook MB, Upshur R, Stukel TA,. Cardiovascular safety of inhaled long-acting bronchodilators in individuals with chronic obstructive pulmonary disease. JAMA Intern Med 2013; 173: 1175-1185.
48. Dahl R, Chapman KR, Rudolf M, Mehta R, Kho P, Alagappan VK, Chen H, Banerji D,. Safety and efficacy of dual bronchodilation with QVA149 in COPD patients: the ENLIGHTEN study. Respir Med 2013; 107: 1558-1567.
49. Welte T, Vogelmeier C, Dahl R, Chapman K, Rudolf M, Mehta R, D'Andrea P, Chen H, Banerji D,. Once-daily QVA149 has a good safety profile in patients with COPD (P757). Presented at the European Respiratory Society Annual Congress. Barcelona, September 7-11, 2013.
50. Rodrigo GJ, Plaza V,. Efficacy and safety of a fixed-dose combination of indacaterol and glycopyrronium (QVA149) for the treatment of COPD: a systematic review. Chest 2014; 146: 309-317.
51. Donohue JF, Niewoehner D, Brooks J, O'Dell D, Church A,. 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 2014; 15: 78.
52. Make B, Donohue J, Zhong X, Leselbaum A, Caracta C,. Long-term safety of a fixed-dose combination of aclidinium bromide/formoterol fumarate in patients with stable moderate to severe COPD. Chest 2014; 145: 386A. Presented at CHEST, Madrid, March 21-24, 2014.
53. Jones PW, Beeh KM, Chapman KR, Decramer M, Mahler DA, Wedzicha JA,. Minimal clinically important differences in pharmacological trials. Am J Respir Crit Care Med 2014; 189: 250-255.
54. Witek TJ Jr, Mahler DA,. Minimal important difference of the transition dyspnoea index in a multinational clinical trial. Eur Respir J 2003; 21: 267-272.
55. Calverley PM, Anderson JA, Celli B, Ferguson GT, Jenkins C, Jones PW, Yates JC, Vestbo J, Investigators T. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med 2007; 356: 775-789.
56. Tashkin DP, Celli B, Senn S, Burkhart D, Kesten S, Menjoge S, Decramer M, Investigators US,. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med 2008; 359: 1543-1554.
57. 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: 161-171.
58. Wedzicha JA, Calverley PM, Seemungal TA, Hagan G, Ansari Z, Stockley RA, Investigators I,. 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.
59. Decramer M, Celli B, Kesten S, Lystig T, Mehra S, Tashkin DP, UPLIFT Investigators. Effect of tiotropium on outcomes in patients with moderate chronic obstructive pulmonary disease (UPLIFT): a prespecified subgroup analysis of a randomised controlled trial. Lancet 2009; 374: 1171-1178.