Long-term safety and efficacy of glycopyrrolate/formoterol metered dose inhaler using novel Co-Suspension™ Delivery Technology in patients with chronic obstructive pulmonary disease

Respiratory Medicine

Volumn 126, Issue , 2017, Pages 105-115

  Hanania, Nicola A ^a   Tashkin, Donald P ^b   Kerwin, Edward M ^c   Donohue, James F ^d   Denenberg, Michael ^e   O'Donnell, Denis E ^f   Quinn, Dean ^g   Siddiqui, Shahid ^h   Orevillo, Chad ^h   Maes, Andrea ^h   Reisner, Colin ^h  

^a BAYLOR COLLEGE OF MEDICINE   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c Clinical Research Institute of Southern Oregon PC   (United States)

^d UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

^e Clinical Research of Rock Hill   (United States)

^f QUEEN S UNIVERSITY   (Canada)

^g P3 Research   (New Zealand)

^h ASTRAZENECA   (United Kingdom)

Author keywords

Co Suspension Delivery Technology; COPD; Metered dose inhaler; Muscarinic antagonists; 2 agonist

Indexed keywords

FORMOTEROL FUMARATE; FORMOTEROL FUMARATE PLUS GLYCOPYRRONIUM BROMIDE; GLYCOPYRRONIUM; SALBUTAMOL; TIOTROPIUM BROMIDE; BETA 2 ADRENERGIC RECEPTOR STIMULATING AGENT; BRONCHODILATING AGENT; MUSCARINIC RECEPTOR BLOCKING AGENT;

ACUTE HEART INFARCTION; ADULT; ARTHRALGIA; ARTICLE; BACKACHE; BRAIN HEMORRHAGE; BRONCHITIS; CARDIOVASCULAR DISEASE; CEREBROVASCULAR ACCIDENT; CHRONIC OBSTRUCTIVE LUNG DISEASE; COMPARATIVE EFFECTIVENESS; COMPUTERIZED TRANSITION DYSPNEA INDEX FOCAL SCORE; CONTROLLED STUDY; CORONARY ARTERY OCCLUSION; COUGHING; DISEASE EXACERBATION; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; FEMALE; FORCED EXPIRATORY VOLUME; HEALTH CARE UTILIZATION; HEART ARREST; HEART FAILURE; HEART INFARCTION; HUMAN; INFECTION; INFESTATION; LUNG EDEMA; MAJOR CLINICAL STUDY; MALE; METERED DOSE INHALER; MIDDLE AGED; MINIMAL CLINICALLY IMPORTANT DIFFERENCE; NAUSEA; PHASE 3 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SINUSITIS; ST. GEORGE RESPIRATORY QUESTIONNAIRE; SUDDEN CARDIAC DEATH; THROMBOSIS; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; AGED; CLINICAL TRIAL; COMBINATION DRUG THERAPY; DRUG EFFECTS; DRUG TOLERANCE; EPIDEMIOLOGY; INHALATIONAL DRUG ADMINISTRATION; SEVERITY OF ILLNESS INDEX; SMOKING; TREATMENT OUTCOME; UTILIZATION;

ADMINISTRATION, INHALATION; ADRENERGIC BETA-2 RECEPTOR AGONISTS; AGED; BRONCHODILATOR AGENTS; DRUG THERAPY, COMBINATION; DRUG TOLERANCE; DYSPNEA; FEMALE; FORCED EXPIRATORY VOLUME; FORMOTEROL FUMARATE; GLYCOPYRROLATE; HUMANS; MALE; METERED DOSE INHALERS; MIDDLE AGED; MUSCARINIC ANTAGONISTS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; SEVERITY OF ILLNESS INDEX; SMOKING; TIOTROPIUM BROMIDE; TREATMENT OUTCOME;

EID: 85016734879     PISSN: 09546111     EISSN: 15323064     Source Type: Journal    
DOI: 10.1016/j.rmed.2017.03.015     Document Type: Article

References (50)

1. [1] Global Initiative for Chronic Obstructive Lung Diseases, Global Strategy for the Diagnosis, Management and Prevention of COPD, 2016 http://www.goldcopd.org (Accessed 30 October 16).
2. [2] Cazzola, M., Molimard, M., The scientific rationale for combining long-acting beta2-agonists and muscarinic antagonists in COPD. Pulm. Pharmacol. Ther. 23:4 (2010), 257–267.
3. [3] Yu, A.P., Guerin, A., Ponce de Leon, D., Ramakrishnan, K., Wu, E.Q., Mocarski, M., et al. Therapy persistence and adherence in patients with chronic obstructive pulmonary disease: multiple versus single long-acting maintenance inhalers. J. Med. Econ. 14:4 (2011), 486–496.
4. [4] Yu, A.P., Guérin, A., de Leon, D.P., Ramakrishnan, K., Wu, E.Q., Mocarski, M., et al. Clinical and economic outcomes of multiple versus single long-acting inhalers in COPD. Respir. Med. 105:12 (2011), 1861–1871.
5. [5] Almirall, S.A., Duaklir Genuair Summary of Product Characteristics. 2015 http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003745/human_med_001811.jsp&mid=WC0b01ac058001d124 (Accessed 01 June 15).
6. [6] Boehringer Ingelheim, Stiolto Respimat Prescribing Information. 2015.
7. [7] Glaxo, EMA Anoro Ellipta Summary of Product Characteristics. 2015.
8. [8] Novartis, Utibron Neohaler Prescribing Information. 2015.
9. [9] Novartis Pharma GmbH, Ultibro Breezhaler Summary of Product Characteristics. 2015 http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002679/human_med_001691.jsp&mid=WC0b01ac058001d124 (Accessed 01 May 2015).
10. [10] Buhl, R., Maltais, F., Abrahams, R., Bjermer, L., Derom, E., Ferguson, G., et al. Tiotropium and olodaterol fixed-dose combination versus mono-components in COPD (GOLD 2-4). Eur. Respir. J. 45:4 (2015), 969–979.
11. [11] D'Urzo, A.D., Rennard, S.I., Kerwin, E.M., Mergel, V., Leselbaum, A.R., Caracta, C.F., Efficacy and safety of fixed-dose combinations of aclidinium bromide/formoterol fumarate: the 24-week, randomized, placebo-controlled AUGMENT COPD study. Respir. Res., 15(1), 2014, 123.
12. [12] Bateman, E.D., Ferguson, G.T., Barnes, N., Gallagher, N., Green, Y., Henley, M., et al. Dual bronchodilation with QVA149 versus single bronchodilator therapy: the SHINE study. Eur. Respir. J. 42:6 (2013), 1484–1494.
13. [13] Beeh, K.M., Korn, S., Beier, J., Jadayel, D., Henley, M., D'Andrea, P., et al. Effect of QVA149 on lung volumes and exercise tolerance in COPD patients: the BRIGHT study. Respir. Med. 108:4 (2014), 584–592.
14. [14] Beeh, K.M., Westerman, J., Kirsten, A.M., Hebert, J., Gronke, L., Hamilton, A., et al. The 24-h lung-function profile of once-daily tiotropium and olodaterol fixed-dose combination in chronic obstructive pulmonary disease. Pulm. Pharmacol. Ther. 32 (2015), 53–59.
15. [15] Celli, B., Crater, G., Kilbride, S., Mehta, R., Tabberer, M., Kalberg, C.J., et al. Once-daily umeclidinium/vilanterol 125/25 mcg in COPD: a randomized, controlled study. Chest 145:5 (2014), 981–991.
16. [16] Decramer, M., Anzueto, A., Kerwin, E., Kaelin, T., Richard, N., Crater, G., 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. 2:6 (2014), 472–486.
17. [17] Joshi, V., Lechuga-Ballesteros, D., Flynn, B., Vehring, R., Schultz, R., Noga, B., et al. Development of mono, dual and triple combination pMDIs without co-formulation effect. Resp. Drug Deliv. Eur. 2 (2011), 383–386.
18. [18] Lechuga-Ballesteros, D., Noga, B., Vehring, R., Cummings, R.H., Dwivedi, S.K., Novel cosuspension metered-dose inhalers for the combination therapy of chronic obstructive pulmonary disease and asthma. Future Med. Chem. 3:13 (2011), 1703–1718.
19. [19] Lechuga-Ballesteros, D., Vehring, R., Dwivedi, S.K., A new co-suspension MDI platform: scientific foundations of mono, dual and triple combination products. RDD Eur. 1 (2011), 101–112.
20. [20] Lechuga-Ballesteros, D., Vehring, R., Joshi, V., Noga, B., Cummings, R.H., Schultz, R., et al. A New Formulation Platform for Metered Dose Inhaler Combination Products: Cosuspensions of Engineered Phospholipid Microparticles with Micronized Actives. Poster presented at the annual meeting of the American Association of Pharmaceutical Scienes (AAPS), Washington DC, USA, 2011.
21. [21] Vehring, R., Lechuga-Ballesteros, D., Joshi, V., Noga, B., Dwivedi, S.K., Cosuspensions of microcrystals and engineered microparticles for uniform and efficient delivery of respiratory therapeutics from pressurized metered dose inhalers. Langmuir 28:42 (2012), 15015–15023.
22. [22] Martinez, F.J., Rabe, K.F., Ferguson, G.T., Fabbri, L.M., Rennard, S., Feldman, G.J., et al. Efficacy and safety of glycopyrrolate/formoterol MDI formulated using Co-Suspension™ Delivery Technology in patients with COPD. Chest 151:2 (2017), 340–357.
23. [23] International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartate Guideline: Statistical Principles for Clinical Trials E9, (1998).
24. [24] Jones, P.W., St. George's Respiratory Questionnaire: MCID. COPD 2:1 (2005), 75–79.
25. [25] Buhl, R., Gessner, C., Schuermann, W., Foerster, K., Sieder, C., Hiltl, S., et al. Efficacy and safety of once-daily QVA149 compared with the free combination of once-daily tiotropium plus twice-daily formoterol in patients with moderate-to-severe COPD (QUANTIFY): a randomised, non-inferiority study. Thorax 70:4 (2015), 311–319.
26. [26] Donohue, J.F., Maleki-Yazdi, M.R., Kilbride, S., Mehta, R., Kalberg, C., Church, A., Efficacy and safety of once-daily umeclidinium/vilanterol 62.5/25 mcg in COPD. Respir. Med. 107:10 (2013), 1538–1546.
27. [27] Dahl, R., Chapman, K.R., Rudolf, M., Mehta, R., Kho, P., Alagappan, V.K., et al. Safety and efficacy of dual bronchodilation with QVA149 in COPD patients: the ENLIGHTEN study. Respir. Med. 107:10 (2013), 1558–1567.
28. [28] Kerwin, E., Hebert, J., Gallagher, N., Martin, C., Overend, T., Alagappan, V.K., et al. Efficacy and safety of NVA237 versus placebo and tiotropium in patients with COPD: the GLOW2 study. Eur. Respir. J. 40:5 (2012), 1106–1114.
29. [29] Casaburi, R., Mahler, D.A., Jones, P.W., Wanner, A., San, P.G., ZuWallack, R.L., et al. A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease. Eur. Respir. J. 19:2 (2002), 217–224.
30. [30] Chapman, K.R., Rennard, S.I., Dogra, A., Owen, R., Lassen, C., Kramer, B., Long-term safety and efficacy of indacaterol, a long-acting beta(2)-agonist, in subjects with COPD: a randomized, placebo-controlled study. Chest 140:1 (2011), 68–75.
31. [31] Dahl, R., Chung, K.F., Buhl, R., Magnussen, H., Nonikov, V., Jack, D., et al. Efficacy of a new once-daily long-acting inhaled beta2-agonist indacaterol versus twice-daily formoterol in COPD. Thorax 65:6 (2010), 473–479.
32. [32] Singh, D., Jones, P.W., Bateman, E.D., Korn, S., Serra, C., Molins, E., et al. Efficacy and safety of aclidinium bromide/formoterol fumarate fixed-dose combinations compared with individual components and placebo in patients with COPD (ACLIFORM-COPD): a multicentre, randomised study. BMC Pulm. Med., 14, 2014, 178.
33. [33] Voshaar, T., Lapidus, R., Maleki-Yazdi, R., Timmer, W., Rubin, E., Lowe, L., et al. A randomized study of tiotropium Respimat Soft Mist inhaler vs. ipratropium pMDI in COPD. Respir. Med. 102:1 (2008), 32–41.
34. [34] Tashkin, D.P., Celli, B., Senn, S., Burkhart, D., Kesten, S., Menjoge, S., et al. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N. Engl. J. Med. 359:15 (2008), 1543–1554.
35. [35] Kew, K.M., Seniukovich, A., Inhaled steroids and risk of pneumonia for chronic obstructive pulmonary disease. Cochrane Database Syst. Rev., 3, 2014 CD010115.
36. [36] Suissa, S., Patenaude, V., Lapi, F., Ernst, P., Inhaled corticosteroids in COPD and the risk of serious pneumonia. Thorax 68:11 (2013), 1029–1036.
37. [37] Janson, C., Larsson, K., Lisspers, K.H., Stallberg, B., Stratelis, G., Goike, H., et al. Pneumonia and pneumonia related mortality in patients with COPD treated with fixed combinations of inhaled corticosteroid and long acting beta2 agonist: observational matched cohort study (PATHOS). BMJ, 346, 2013 f3306.
38. [38] Cazzola, M., Calzetta, L., Ora, J., Puxeddu, E., Rogliani, P., Matera, M.G., Searching for the synergistic effect between aclidinium and formoterol: from bench to bedside. Respir. Med. 109:10 (2015), 1305–1311.
39. [39] Cazzola, M., Calzetta, L., Segreti, A., Facciolo, F., Rogliani, P., Matera, M.G., Translational study searching for synergy between glycopyrronium and indacaterol. COPD 12:2 (2015), 175–181.
40. [40] Beeh, K.M., Burgel, P.R., Franssen, F.M., Lopez-Campos, J.L., Loukides, S., Hurst, J.R., et al. How do dual long-acting bronchodilators prevent exacerbations of chronic obstructive pulmonary disease?. Am. J. Respir. Crit. Care Med., 2016.
41. [41] Wedzicha, J.A., Banerji, D., Chapman, K.R., Vestbo, J., Roche, N., Ayers, R.T., et al. Indacaterol-glycopyrronium versus salmeterol-fluticasone for COPD. N. Engl. J. Med. 374:23 (2016), 2222–2234.
42. [42] Mahler, D.A., Waterman, L.A., Ward, J., McCusker, C., ZuWallack, R., Baird, J.C., Validity and responsiveness of the self-administered computerized versions of the baseline and transition dyspnea indexes. Chest 132:4 (2007), 1283–1290.
43. [43] Wedzicha, J.A., Decramer, M., Ficker, J.H., Niewoehner, D.E., Sandstrom, T., Taylor, A.F., 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. 1:3 (2013), 199–209.
44. [44] Rogueda, P., Novel hydrofluoroalkane suspension formulations for respiratory drug delivery. Expert Opin. Drug Deliv. 2:4 (2005), 625–638.
45. [45] Lavorini, F., Corrigan, C.J., Barnes, P.J., Dekhuijzen, P.R., Levy, M.L., Pedersen, S., et al. Retail sales of inhalation devices in European countries: so much for a global policy. Respir. Med. 105:7 (2011), 1099–1103.
46. [46] Myrdal, P.B., Sheth, P., Stein, S.W., Advances in metered dose inhaler technology: formulation development. AAPS PharmSciTech 15:2 (2014), 434–455.
47. [47] Stein, S.W., Sheth, P., Hodson, P.D., Myrdal, P.B., Advances in metered dose inhaler technology: hardware development. AAPS. PharmSciTech 15:2 (2014), 326–338.
48. [48] Melani, A.S., Bonavia, M., Cilenti, V., Cinti, C., Lodi, M., Martucci, P., et al. Inhaler mishandling remains common in real life and is associated with reduced disease control. Respir. Med. 105:6 (2011), 930–938.
49. [49] Bjermer, L., The importance of continuity in inhaler device choice for asthma and chronic obstructive pulmonary disease. Respiration 88:4 (2014), 346–352.
50. [50] Small, M., Anderson, P., Vickers, A., Kay, S., Fermer, S., Importance of inhaler-device satisfaction in asthma treatment: real-world observations of physician-observed compliance and clinical/patient-reported outcomes. Adv. Ther. 28:3 (2011), 202–212.