Corrigendum to “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 November 2016 16–24] (S0954611116302359) (10.1016/j.rmed.2016.09.012));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

Respiratory Medicine

Volumn 120, Issue , 2016, Pages 16-24

  Tashkin, Donald P ^a   Martinez, Fernando J ^b   Rodriguez Roisin, Roberto ^c   Fogarty, Charles ^d   Gotfried, Mark ^e   Denenberg, Michael ^f   Gottschlich, Gregory ^g   Donohue, James F ^h   Orevillo, Chad ⁱ   Darken, Patrick ⁱ   St Rose, Earl ⁱ   Strom, Shannon ⁱ   Fischer, Tracy ⁱ   Golden, Michael ⁱ   Reisner, Colin ⁱ  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b WEILL CORNELL MEDICAL COLLEGE   (United States)

^c UNIVERSITY OF BARCELONA   (Spain)

^d Southeast Clinical Oncology Research   (United States)

^e Pulmonary Associates   (United States)

^f Clinical Research of Rock Hill   (United States)

^g New Horizons Clinical Research   (United States)

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

ⁱ ASTRAZENECA   (United Kingdom)

Author keywords

Bronchodilators; Co Suspension Delivery Technology; COPD maintenance therapy; Fixed dose combinations; LABA; LAMA

Indexed keywords

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

ADULT; ARTICLE; BODY MASS; BRONCHODILATATION; CHRONIC OBSTRUCTIVE LUNG DISEASE; CONTROLLED STUDY; CONTUSION; COUGHING; DIARRHEA; DISEASE SEVERITY; DRUG EFFICACY; DRUG SAFETY; DRY POWDER INHALER; DYSPNEA; FORCED EXPIRATORY VOLUME; FORCED VITAL CAPACITY; HEADACHE; HUMAN; HYPERKALEMIA; INTENTION TO TREAT ANALYSIS; MAJOR CLINICAL STUDY; MALE; METERED DOSE INHALER; MULTICENTER STUDY; MUSCLE SPASM; NOSE OBSTRUCTION; OPTIMAL DRUG DOSE; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; TREMOR; UPPER RESPIRATORY TRACT INFECTION; VOMITING; XEROSTOMIA; CLINICAL TRIAL; COMPARATIVE STUDY; CROSSOVER PROCEDURE; DOUBLE BLIND PROCEDURE; DRUG COMBINATION; DRUG EFFECTS; FEMALE; INHALATIONAL DRUG ADMINISTRATION; MIDDLE AGED; PROCEDURES; TREATMENT OUTCOME; UTILIZATION;

ADMINISTRATION, INHALATION; ADRENERGIC BETA-2 RECEPTOR AGONISTS; CHOLINERGIC ANTAGONISTS; CROSS-OVER STUDIES; DOUBLE-BLIND METHOD; DRUG COMBINATIONS; DRY POWDER INHALERS; FEMALE; FORCED EXPIRATORY VOLUME; FORMOTEROL FUMARATE; GLYCOPYRROLATE; HUMANS; MALE; METERED DOSE INHALERS; MIDDLE AGED; MUSCARINIC ANTAGONISTS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; TIOTROPIUM BROMIDE; TREATMENT OUTCOME;

EID: 84989235537     PISSN: 09546111     EISSN: 15323064     Source Type: Journal    
DOI: 10.1016/j.rmed.2017.06.011     Document Type: Erratum

References (46)

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 Diseases (GOLD). 2016 http://www.goldcopd.org (accessed 16.06.16).
2. [2] Cazzola, M., Tashkin, D.P., Combination of formoterol and tiotropium in the treatment of COPD: effects on lung function. COPD 6:5 (2009), 404–415.
3. [3] Cazzola, M., Page, C.P., Calzetta, L., Matera, M.G., Pharmacology and therapeutics of bronchodilators. Pharmacol. Rev. 64:3 (2012), 450–504.
4. [4] Tashkin, D.P., Ferguson, G.T., Combination bronchodilator therapy in the management of chronic obstructive pulmonary disease. Respir. Res., 14, 2013, 49.
5. [5] 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.
6. [6] 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.
7. [7] 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, 2014, 10–1579.
8. [8] 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.
9. [9] 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.
10. [10] 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. 14:178 (2014), 178–214.
11. [11] 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.
12. ®. 2013 http://www.atsjournals.org/doi/abs/10.1164/ajrccm-conference.2013.187.1_MeetingAbstracts.A1485 (accessed 01.04.15).
13. [13] Reisner, C., Orevillo, C., Fernandez, C., Darken, P., St Rose, E., Golden, M., 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. 2013 http://erj.ersjournals.com/content/42/Suppl_57/P4153 (accessed 01.06.16).
14. [14] Reisner, C., Gotfried, M., Denenberg, M.B., Fernandez, C., St Rose, E., Fortner, P., et al. Low Doses of Pearl Therapeutics’ LAMA/LABA Combination MDI (GFF MDI, PT003) Provide Superior Bronchodilation Compared to Components and to Open-label Spiriva Handihaler in a Randomized, Double-blind, Placebo-controlled Phase IIb Study in Patients with COPD. 2013 http://www.atsjournals.org/doi/abs/10.1164/ajrccm-conference.2013.187.1_MeetingAbstracts.A2434 (accessed 21.06.16).
15. [15] 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.
16. [16] Dellamary, L.A., Tarara, T.E., Smith, D.J., Woelk, C.H., Adractas, A., Costello, M.L., et al. Hollow porous particles in metered dose inhalers. Pharm. Res. 17:2 (2000), 168–174.
17. [17] Ivey, J.W., Vehring, R., The use of modeling in spray drying of emulsions and suspensions accelerates formulation and process development. Comput. Chem. Eng. 34:7 (2015), 1036–1040.
18. [18] Chapman, K.R., Beeh, K.M., Beier, J., Bateman, E.D., D'Urzo, A., Nutbrown, R., et al. A blinded evaluation of the efficacy and safety of glycopyrronium, a once-daily long-acting muscarinic antagonist, versus tiotropium, in patients with COPD: the GLOW5 study. BMC Pulm. Med., 14, 2014, 4.
19. [19] 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.
20. [20] Santus, P., Radovanovic, D., Di, M.F., Raccanelli, R., Valenti, V., Centanni, S., Faster reduction in hyperinflation and improvement in lung ventilation inhomogeneity promoted by aclidinium compared to glycopyrronium in severe stable COPD patients. A randomized crossover study. Pulm. Pharmacol. Ther. 35 (2015), 42–49.
21. [21] Dahl, R., Greefhorst, L.A., Nowak, D., Nonikov, V., Byrne, A.M., Thomson, M.H., et al. Inhaled formoterol dry powder versus ipratropium bromide in chronic obstructive pulmonary disease. Am. J. Respir. Crit. Care Med. 164:5 (2001), 778–784.
22. [22] Campbell, M., Eliraz, A., Johansson, G., Tornling, G., Nihlen, U., Bengtsson, T., et al. Formoterol for maintenance and as-needed treatment of chronic obstructive pulmonary disease. Respir. Med. 99:12 (2005), 1511–1520.
23. [23] Brusasco, V., Canonica, G.W., Dal, N.R., Scano, G., Paggiaro, P., Fabbri, L.M., et al. Formoterol by pressurized metered-dose aerosol or dry powder on airway obstruction and lung hyperinflation in partially reversible COPD. J. Aerosol Med. Pulm. Drug Deliv. 24:5 (2011), 235–243.
24. [24] Kew, K.M., Mavergames, C., Walters, J.A., Long-acting beta2-agonists for chronic obstructive pulmonary disease, Cochrane. Database. Syst. Rev., 10, 2013, CD010177.
25. [25] Quinn, D., Seale, J.P., Reisner, C., Fischer, T., Golden, M., Fernandez, C., et al. A randomized study of formoterol fumarate in a porous particle metered-dose inhaler in patients with moderate-to-severe COPD. Respir. Med. 108:9 (2014), 1327–1335.
26. [26] Cummings, H., Schultz, R.D., Speck, J.H., Joshi, V., Lechuga-Ballesteros, D., Flynn, B., et al. Performance advantages of Pearl co-suspension formulation technology for manufacturing of metered-dose inhalers. RDD Eur. 2 (2011), 387–390.
27. [27] 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.
28. [28] Vehring, R., Hartman, M.S., Schultz, R., Joshi, V., Sommerville, M., Cummings, R.H., et al. Glycopyrrolate and Formoterol Fumarate Monotherapy and Combination Metered Dose Inhalers with High Dose Uniformity and Stable Aerosol Properties. Abstract Presented at the Ajrccm 2010. 2010.
29. [29] Reisner, C., Fogarty, C., Spangenthal, S., Dunn, L., Kerwin, E.M., Quinn, D., et al. Novel combination of glycopyrrolate and formoterol MDI (GFF-MDI) provides superior bronchodilation compared to its components administered alone, tiotropium DPI, and formoterol DPI in a randomized, double-blind, placebo-controlled phase 2b study in patients with COPD. Am. J. Respir. Crit. Care Med., 183(Suppl), 2011, A6435.
30. [30] Rennard, S.I., Fogarty, C., Ferguson, G.T., Orevillo, C.J., Rose, E.S., Fischer, T., et al. A novel glycopyrrolate metered dose inhaler formulation demonstrates superior bronchodilator efficacy relative to Spiriva handihaler in patients with COPD. Am. J. Respir. Crit. Care Med., 181(A4450), 2010.
31. [31] 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.
32. [32] Jones, P.W., Harding, G., Berry, P., Wiklund, I., Chen, W.H., Kline, L.N., Development and first validation of the COPD assessment test. Eur. Respir. J. 34:3 (2009), 648–654.
33. [33] Jones, P.W., COPD assessment test –rationale, development, validation and performance. COPD 10:2 (2013), 269–271.
34. [34] World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects, 2008, World Medical Association Declaration Of HelsinkI.
35. [35] Miller, M.R., Hankinson, J., Brusasco, V., Burgos, F., Casaburi, R., Coates, A., et al. Standardisation of spirometry. Eur. Respir. J. 26:2 (2005), 319–338.
36. [36] Cazzola, M., MacNee, W., Martinez, F.J., Rabe, K.F., Franciosi, L.G., Barnes, P.J., et al. Outcomes for COPD pharmacological trials: from lung function to biomarkers. Eur. Respir. J. 31:2 (2008), 416–469.
37. [37] Donohue, J.F., Minimal clinically important differences in COPD lung function. COPD 2:1 (2005), 111–124.
38. [38] Rabe, K., Martinez, F., Rodriguez-Roisin, R., Fabbri, L.M., Ferguson, G.T., Jones, P., et al. a novel co-suspension MDI glycopyrronium/formoterol fixed-dose combination is superior to monocomponents in patients with COPD. PT003 Eur. Respir. J., 46(Suppl. 59), 2015, PA4363.
39. [39] Sanguinetti, C.M., The lungs need to be deflated: effects of glycopyrronium on lung hyperinflation in COPD patients. Multidiscip. Respir. Med., 9(19), 2014.
40. [40] O'Donnell, D.E., Impacting patient-centred outcomes in COPD: breathlessness and exercise tolerance. Eur. Resp. Rev. 15:99 (2006), 37–41.
41. [41] 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.
42. [42] 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.
43. [43] Rossi, A., Kristufek, P., Levine, B.E., Thomson, M.H., Till, D., Kottakis, J., et al. Comparison of the efficacy, tolerability, and safety of formoterol dry powder and oral, slow-release theophylline in the treatment of COPD. Chest 121:4 (2002), 1058–1069.
44. ® dry powder inhaler. J. Aerosol Med. Pulm. Drug Deliv. 26:3 (2013), 174–179.
45. [45] Prime, D., de Backer, W., Hamilton, M., Cahn, A., Preece, A., Kelleher, D., et al. Effect of disease severity in asthma and chronic obstructive pulmonary disease on inhaler-specific inhalation profiles through the ELLIPTA dry powder inhaler. J. Aerosol Med. Pulm. Drug Deliv. 28:6 (2015), 486–497.
46. [46] 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.