Efficacy and Safety of Glycopyrrolate/Formoterol Metered Dose Inhaler Formulated Using Co-Suspension Delivery Technology in Patients With COPD

Chest

Volumn 151, Issue 2, 2017, Pages 340-357

  Martinez, Fernando J ^a   Rabe, Klaus F ^b   Ferguson, Gary T ^c   Fabbri, Leonardo M ^d   Rennard, Stephen ^e   Feldman, Gregory J ^f   Sethi, Sanjay ^g   Spangenthal, Selwyn ^h   Gottschlich, Gregory M ^j   Rodriguez Roisin, Roberto ^l   Arora, Samir ^k   Siler, Thomas M ^m   Siddiqui, Shahid ⁱ   Darken, Patrick ⁱ   Fischer, Tracy ⁱ   Maes, Andrea ⁱ   Golden, Michael ⁱ   Orevillo, Chad ⁱ   Reisner, Colin ⁱ  

^a WEILL CORNELL MEDICAL COLLEGE   (United States)

^b UNIVERSITY OF KIEL   (Germany)

^c Pulmonary Research Institute of Southeast Michigan   (United States)

^d UNIVERSITY OF MODENA AND REGGIO EMILIA   (Italy)

^e UNIVERSITY OF NEBRASKA MEDICAL CENTER   (United States)

^f S Carolina Pharmaceutical Research   (United States)

^g UNIVERSITY AT BUFFALO   (United States)

^h American Health Research Inc   (United States)

ⁱ ASTRAZENECA   (United Kingdom)

^j New Horizons Clinical Research   (United States)

^k Aventiv Research Inc   (United States)

^l UNIVERSITY OF BARCELONA   (Spain)

^m PC   (United States)

more..

Author keywords

bronchodilator; chronic bronchitis; emphysema; muscarinic antagonists; 2 agonist

Indexed keywords

FORMOTEROL; FORMOTEROL FUMARATE PLUS GLYCOPYRRONIUM BROMIDE; GLYCOPYRRONIUM; PLACEBO; TIOTROPIUM BROMIDE; BRONCHODILATING AGENT; BUDESONIDE; DRUG COMBINATION; FLUTICASONE; FORMOTEROL FUMARATE; GLUCOCORTICOID; MUSCARINIC RECEPTOR BLOCKING AGENT; PREDNISONE; SUSPENSION;

ADULT; AGED; ANXIETY; ARTHRALGIA; ARTICLE; BACKACHE; BRONCHITIS; CHRONIC OBSTRUCTIVE LUNG DISEASE; CONSTIPATION; COUGHING; DEPRESSION; DIARRHEA; DISEASE SEVERITY; DRUG DELIVERY SYSTEM; DRUG EFFICACY; DRUG FORMULATION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; FEMALE; FORCED EXPIRATORY VOLUME; GASTROESOPHAGEAL REFLUX; HEADACHE; HUMAN; HYPERTENSION; MAJOR CLINICAL STUDY; MALE; MEDICAL DECISION MAKING; METERED DOSE INHALER; MIDDLE AGED; MULTICENTER STUDY (TOPIC); MUSCLE SPASM; NAUSEA; OROPHARYNX PAIN; PHASE 2 CLINICAL TRIAL (TOPIC); PNEUMONIA; RANDOMIZED CONTROLLED TRIAL (TOPIC); RHINOPHARYNGITIS; RHINORRHEA; SIDE EFFECT; SINUSITIS; SUSPENSION; THORAX PAIN; TOOTH ABSCESS; TREATMENT OUTCOME; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; VERY ELDERLY; VOMITING; XEROSTOMIA; CLINICAL TRIAL; COMBINATION DRUG THERAPY; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG COMBINATION; INHALATIONAL DRUG ADMINISTRATION; PATHOPHYSIOLOGY; PHASE 3 CLINICAL TRIAL; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; RANDOMIZED CONTROLLED TRIAL; VITAL CAPACITY;

ADMINISTRATION, INHALATION; ADULT; AGED; AGED, 80 AND OVER; BRONCHODILATOR AGENTS; BUDESONIDE; DOUBLE-BLIND METHOD; DRUG COMBINATIONS; DRUG THERAPY, COMBINATION; FEMALE; FLUTICASONE; FORCED EXPIRATORY VOLUME; FORMOTEROL FUMARATE; GLUCOCORTICOIDS; GLYCOPYRROLATE; HUMANS; MALE; METERED DOSE INHALERS; MIDDLE AGED; MUSCARINIC ANTAGONISTS; PREDNISONE; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; SUSPENSIONS; VITAL CAPACITY;

EID: 85011575320     PISSN: 00123692     EISSN: 19313543     Source Type: Journal    
DOI: 10.1016/j.chest.2016.11.028     Document Type: Article

References (39)

1. 1 Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management and prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2016. http://www.goldcopd.org/. Accessed October 4, 2016.
2. 2 Bateman, E.D., Ferguson, G.T., Barnes, N., et al. Dual bronchodilation with QVA149 vs single bronchodilator therapy: the SHINE study. Eur Respir J 42:6 (2013), 1484–1494.
3. 3 Beeh, K.M., Korn, S., Beier, J., et al. Effect of QVA149 on lung volumes and exercise tolerance in COPD patients: the BRIGHT study. Respir Med 108:4 (2014), 584–592.
4. 4 Beeh, K.M., Westerman, J., Kirsten, A.M., 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.
5. 5 Decramer, M., Anzueto, A., Kerwin, E., et al. Efficacy and safety of umeclidinium plus vilanterol vs 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.
6. 6 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, 2014, 123.
7. 7 Buhl, R., Maltais, F., Abrahams, R., et al. Tiotropium and olodaterol fixed-dose combination vs mono-components in COPD (GOLD 2-4). Eur Respir J 45:6 (2015), 969–979.
8. 8 Mahler, D.A., Kerwin, E., Ayers, T., et al. FLIGHT1 and FLIGHT2: efficacy and safety of QVA149 (indacaterol/glycopyrrolate) vs its monocomponents and placebo in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 192:9 (2015), 1068–1079.
9. 9 Tashkin, D.P., Ferguson, G.T., Combination bronchodilator therapy in the management of chronic obstructive pulmonary disease. Respir Res, 14, 2013, 49.
10. 10 Cohen, J.S., Miles, M.C., Donohue, J.F., Ohar, J.A., Dual therapy strategies for COPD: the scientific rationale for LAMA + LABA. Int J Chron Obstruct Pulmon Dis 11 (2016), 785–797.
11. 11 Sulaiman I, Cushen B, Greene G, et al. Objective assessment of adherence to inhalers by COPD patients [Published online ahead of print, July 13, 2016]. Am J Respir Crit Care Med.
12. 12 Braido, F., Chrystyn, H., Baiardini, I., et al. “Trying, but failing”—the role of inhaler technique and mode of delivery in respiratory medication adherence. J Allergy Clin Immunol Pract 4:5 (2016), 823–832.
13. 13 Rogueda, P., Novel hydrofluoroalkane suspension formulations for respiratory drug delivery. Expert Opin Drug Deliv 2:4 (2005), 625–638.
14. 14 Joshi, V., Lechuga-Ballesteros, D., Flynn, B., et al. Development of mono, dual and triple combination pMDIs without co-formulation effect. RDD Europe 2 (2011), 383–386.
15. 15 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.
16. 16 Lechuga-Ballesteros D, Vehring R, Joshi V, 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 Sciences (AAPS); October 23-27, 2011;Washington, DC.
17. 17 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.
18. 18 Buhl, R., Banerji, D., Profile of glycopyrronium for once-daily treatment of moderate-to-severe COPD. Int J Chron Obstruct Pulmon Dis 7 (2012), 729–741.
19. 19 Campbell, M., Eliraz, A., Johansson, G., et al. Formoterol for maintenance and as-needed treatment of chronic obstructive pulmonary disease. Respir Med 99:12 (2005), 1511–1520.
20. 20 Chapman, K.R., Beeh, K.M., Beier, J., et al. A blinded evaluation of the efficacy and safety of glycopyrronium, a once-daily long-acting muscarinic antagonist, vs tiotropium, in patients with COPD: the GLOW5 study. BMC Pulm Med, 14, 2014, 4.
21. 21 Kerwin, E., Hebert, J., Gallagher, N., et al. Efficacy and safety of NVA237 vs placebo and tiotropium in patients with COPD: the GLOW2 study. Eur Respir J 40:5 (2012), 1106–1114.
22. 22 Reisner, C., Orevillo, C., Fernandez, C., et al. Pooled analyses of five phase 2b studies support dose selection of glycopyrrolate-formoterol fumarate (GFF) MDI (PT003) 18/9.6 μg for phase III development. Eur Respir J, 42(suppl 57), 2013, P4153.
23. 23 Orevillo C, Gotfried M, Denenberg MB, et al. Combination glycopyrronium and formoterol fumarate inhalation aerosol (PT003) at a dose of 14.4/9.6 μg provides superior improvement in inspiratory capacity compared to tiotropium dry powder inhaler (DPI) in subjects with moderate to severe COPD. http://www.atsjournals.org/doi/abs/10.1164/ajrccm-conference.2014.189.1_MeetingAbstracts.A3759. Accessed June 14, 2016.
24. 24 Reisner C, Fernandez C, St Rose E, et al. Characterization of the dose response of Pearl Therapeutics' LAMA MDI (GP MDI, PT001) from 36 micrograms to 600 nanograms BID; results from an integrated analysis of phase IIb studies in patients with COPD. http://www.atsjournals.org/doi/abs/10.1164/ajrccm-conference.2013.187.1_MeetingAbstracts.A4274. Accessed June 15, 2016.
25. 25 Tashkin, D.P., Martinez, F.J., Rodriguez-Roisin, R., et al. A multicenter, randomized, double-blind dose-ranging study of glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler compared to the monocomponents and open-label tiotropium dry powder inhaler in patients with moderate-to-severe COPD. Respir Med 120 (2016), 16–24.
26. 26 Fabbri, L.M., Kerwin, E.M., Spangenthal, S., et al. Dose-response to inhaled glycopyrrolate delivered with a novel Co-Suspension Delivery Technology metered dose inhaler (MDI) in patients with moderate-to-severe COPD. Respir Res, 17(1), 2016, 109.
27. ® in moderate-to-severe COPD: a randomized, dose-ranging study. Chronic Obstr Pulm Dis (Miami) 4:1 (2017), 818–830.
28. 28 Celli, B.R., MacNee, W., Standards for the diagnosis and treatment of patients with COPD: a summary of the ATS/ERS position paper. Eur Respir J 23:6 (2004), 932–946.
29. 29 Medical Research Council. MRC Dyspnoea scale/MRC Breathlessness scale. https://www.mrc.ac.uk/research/facilities/mrc-scales/mrc-dyspnoea-scale-mrc-breathlessness-scale/. Accessed June 15, 2016.
30. 30 GlaxoSmithKline. COPD assessment test. http://www.catestonline.org/. Accessed June 15, 2016.
31. 31 Miller, M.R., Hankinson, J., Brusasco, V., et al. Standardisation of spirometry. Eur Respir J 26:2 (2005), 319–338.
32. 32 St. George's University of London. St George's Respiratory Questionnaire (SGRQ). http://www.healthstatus.sgul.ac.uk/. Accessed October 4, 2016.
33. 33 Donohue, J.F., Minimal clinically important differences in COPD lung function. COPD 2:1 (2005), 111–124.
34. 34 Wedzicha, J.A., Banerji, D., Chapman, K.R., et al. Indacaterol-glycopyrronium vs salmeterol-fluticasone for COPD. N Engl J Med 374:23 (2016), 2222–2234.
35. 35 Dahl, R., Jadayel, D., Alagappan, V.K., 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 8 (2013), 501–508.
36. 36 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.
37. 37 Singh, D., New combination bronchodilators for COPD: current evidence and future perspectives. Br J Clin Pharmacol 79:5 (2015), 695–708.
38. 38 Singh, D., Jones, P.W., Bateman, E.D., 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.
39. 39 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. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E9/Step4/E9_Guideline.pdf. Accessed October 4, 2016.