Patient-reported outcomes and considerations in the management of COPD: Focus on aclidinium

Patient Preference and Adherence

Volumn 9, Issue , 2015, Pages 95-104

  Lopez Campos, Jose Luis ^a,b   Calero, Carmen ^a,b   Lopez Ramirez, Cecilia ^a   Asensio Cruz, Maria Iisabel ^a   Márquez Martín, Eduardo ^a   Ortega Ruiz, Francisco ^a,b  

^a HOSPITAL UNIVERSITARIO VIRGEN DEL ROCÍO   (Spain)

^b INSTITUTO DE SALUD CARLOS III   (Spain)

Author keywords

Aclidinium; Bronchodilators; Chronic obstructive pulmonary disease; Patient reported outcomes

Indexed keywords

ACLIDINIUM BROMIDE; PLACEBO; TIOTROPIUM BROMIDE;

ANTICHOLINERGIC SYNDROME; ARTHRALGIA; BACKACHE; BRONCHIECTASIS; BRONCHITIS; CHRONIC OBSTRUCTIVE LUNG DISEASE; COMPUTER ASSISTED TOMOGRAPHY; COUGHING; DIARRHEA; DIZZINESS; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; DRY POWDER INHALER; DYSPEPSIA; DYSPNEA; FATIGUE; FORCED EXPIRATORY VOLUME; HEADACHE; HEALTH STATUS; HUMAN; HYPERTENSION; INFLUENZA; INSOMNIA; LUNG FUNCTION; NAUSEA; OROPHARYNX PAIN; QUALITY OF LIFE; REVIEW; RHINITIS; RHINOPHARYNGITIS; SPIROMETRY; SPUTUM; SPUTUM CULTURE; TOOTH PAIN; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; XEROSTOMIA;

EID: 84921672593     PISSN: None     EISSN: 1177889X     Source Type: Journal    
DOI: 10.2147/PPA.S55009     Document Type: Review

References (76)

1. Lopez-Campos JL, Ruiz-Ramos M, Soriano JB. Mortality trends in chronic obstructive pulmonary disease in Europe, 1994–2010: a joinpoint regression analysis. Lancet. 2014;2(1):54–62.
2. Lozano R, Naghavi M, Foreman K, et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the global burden of disease study 2010. Lancet. 2012;380(9859):2095–2128.
3. Janson C, Marks G, Buist S, et al. The impact of COPD on health status: fndings from the BOLD study. Eur Res J. 2013;42(6):1472–1483.
4. Lopez-Campos JL, Hartl S, Pozo-Rodriguez F, Roberts CM; European COPD Audit team. Variability of hospital resources for acute care of COPD patients: the European COPD audit. Eur Res J. 2014;43(3): 754–762.
5. Pauwels RA, Löfdahl CG, Laitinen LA, et al. Long-term treatment with inhaled budesonide in persons with mild chronic obstructive pulmonary disease who continue smoking. European Respiratory Society study on chronic obstructive pulmonary disease. N Engl J Med. 1999; 340(25):1948–1953.
6. Rabe KF, Hurd S, Anzueto A, et al; Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2007;176(6): 532–555.
7. Vestbo J, Anderson W, Coxson HO, et al; ECLIPSE investigators. Evaluation of COPD longitudinally to identify predictive surrogate end-points (ECLIPSE). Eur Res J. 2008;31(4):869–873.
8. Agusti A, Calverley PM, Celli B, et al; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) Investigators. Characterisation of COPD heterogeneity in the ECLIPSE cohort. Respir Res. 2010;11:122.
9. Lopez-Campos JL, Bustamante V, Munoz X, Barreiro E. Moving towards patient-centered medicine for COPD management: multidimensional approaches versus phenotype-based medicine-a critical view. Chronic Obstr Pulm Dis. 2014;11(5): 591–602.
10. Vestbo J, Hurd SS, Agustí AG, et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013; 187(4):347–365.
11. Zogg S, Durr S, Miedinger D, Steveling EH, Maier S, Leuppi JD. Differences in classification of COPD patients into risk groups A–D: a cross-sectional study. BMC Res Notes. 2014;7(1):562.
12. Jones P, Miravitlles M, van der Molen T, Kulich K. Beyond FEV(1) in COPD: a review of patient-reported outcomes and their measurement. Int J Chron Obstruct Pulmon Dis. 2012;7:697–709.
13. Singer JP, Yusen RD. Defning patient-reported outcomes in chronic obstructive pulmonary disease: the patient-centered experience. Med Clin North Am. 2012;96(4):767–787.
14. Rutten-van Molken MP, Oostenbrink JB, Miravitlles M, Monz BU. Modelling the 5-year cost effectiveness of tiotropium, salmeterol and ipratropium for the treatment of chronic obstructive pulmonary disease in Spain. Eur J Health Econ. 2007;8(2):123–135.
15. Alagha K, Palot A, Sofalvi T, et al. Long-acting muscarinic receptor antagonists for the treatment of chronic airway diseases. Ther Adv Chronic Dis. 2014;5(2):85–98.
16. Miravitlles M, Soler-Cataluna JJ, Calle M, et al. Spanish guideline for COPD (GesEPOC). Update 2014. Arch Bronconeumol. 2014;50 (suppl 1):1–16.
17. Tashkin DP, Celli B, Senn S, et al; UPLIFT Study Investigators. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med. 2008;359(15):1543–1554.
18. Bedard ME, Brouillard C, Pepin V, et al. Tiotropium improves walking endurance in COPD. Eur Respir J. 2012;39(2):265–271.
19. Mathioudakis AG, Kanavidis P, Chatzimavridou-Grigoriadou V, et al. Tiotropium HandiHaler improves the survival of patients with COPD: a systematic review and meta-analysis. J Aerosol Med Pulm Drug Deliv. 2014;27(1):43–50.
20. Wise RA, Anzueto A, Cotton D, et al; TIOSPIR Investigators. Tiotropium Respimat inhaler and the risk of death in COPD. N Engl J Med. 2013;369(16):1491–1501.
21. Soler-Cataluña JJ, Cosío B, Izquierdo JL, et al. Consensus document on the overlap phenotype COPD-asthma in COPD. Arch Bronconeumol. 2012;48(9):331–337.
22. Hardin M, Cho M, McDonald ML, et al. The clinical and genetic features of COPD-asthma overlap syndrome. Eur Respir J. 2014;44(2): 341–350.
23. Fletcher CM. The clinical diagnosis of pulmonary emphysema; an experimental study. Proc R Soc Med. 1952;45(9):577–584.
24. 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(6): 751–758.
25. Witek TJ Jr, Mahler DA. Minimal important difference of the transition dyspnoea index in a multinational clinical trial. Eur Respir J. 2003;21(2):267–272.
26. Dobbels F, de Jong C, Drost E, et al; PROactive consortium. The PROactive innovative conceptual framework on physical activity. Eur Respiratory journal. 2014;44(5):1223–1233.
27. Crawford B, Monz B, Hohlfeld J, et al. Development and validation of a cough and sputum assessment questionnaire. Eur Respir Med. 2008;102(11):1545–1555.
28. Kessler R, Partridge MR, Miravitlles M, et al. Symptom variability in patients with severe COPD: a pan-European cross-sectional study. Eur Respir J. 2011;37(2):264–272.
29. Partridge MR, Karlsson N, Small IR. Patient insight into the impact of chronic obstructive pulmonary disease in the morning: an internet survey. Curr Med Res Opin. 2009;25(8):2043–2048.
30. Gavaldà A, Miralpeix M, Ramos I, et al. Characterization of aclidinium bromide, a novel inhaled muscarinic antagonist, with long duration of action and a favorable pharmacological profle. J Pharmacol Exp Ther. 2009;331(2):740–751.
31. Sentellas S, Ramos I, Albertí J, et al. Aclidinium bromide, a new, long-acting, inhaled muscarinic antagonist: in vitro plasma inactivation and pharmacological activity of its main metabolites. Eur J Pharm Sci. 2010;39(5):283–290.
32. de la Motte S, Beier J, Schmid K, Pascual S, Jansat JM, Gil EG. Pharmacokinetics and safety of aclidinium bromide in younger and elderly patients with chronic obstructive pulmonary disease. Int J Clin Pharmacol Ther. 2012;50(6):403–412.
33. Kerwin EM, D’Urzo AD, Gelb AF, et al; ACCORD I study investigators. Effcacy and safety of a 12-week treatment with twice-daily aclidinium bromide in COPD patients (ACCORD COPD I). Chronic Obstr Pulm Dis. 2012;9(2):90–101.
34. Rennard SI, Scanlon PD, Ferguson GT, et al. ACCORD COPD II: a randomized clinical trial to evaluate the 12-week efficacy and safety of twice-daily aclidinium bromide in chronic obstructive pulmonary disease patients. Clin Drug Investig. 2013;33(12):893–904.
35. Jones PW, Singh D, Bateman ED, et al. Efficacy and safety of twice-daily aclidinium bromide in COPD patients: the ATTAIN study. Eur Respir J. 2012;40(4):830–836.
36. Jones PW, Lamarca R, Chuecos F, et al. Characterisation and impact of reported and unreported exacerbations: results from ATTAIN. Eur Respir J. 2014;44(5):1156–1165.
37. Ni H, Soe Z, Moe S. Aclidinium bromide for stable chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2014;9: CD010509.
38. D’Urzo A, Kerwin E, Rennard S, He T, Gil EG, Caracta C. One-year extension study of ACCORD COPD I: safety and effcacy of two doses of twice-daily aclidinium bromide in patients with COPD. Chronic Obstr Pulm Dis. 2013;10(4):500–510.
39. Gelb AF, Tashkin DP, Make BJ, et al; LAS-MD-35 Study Investigators. Long-term safety and efficacy of twice-daily aclidinium bromide in patients with COPD. Respir Med. 2013;107(12):1957–1965.
40. Fuhr R, Magnussen H, Sarem K, et al. Efficacy of aclidinium bromide 400 ug twice daily compared with placebo and tiotropium in patients with moderate to severe COPD. Chest. 2012;141(3):745–752.
41. Beier J, Kirsten AM, Mróz R, et al. Efficacy and safety of aclidinium bromide compared with placebo and tiotropium in patients with moderate-to-severe chronic obstructive pulmonary disease: results from a 6-week, randomized, controlled Phase IIIb study. Chronic Obstr Pulm Dis. 2013;10(4):511–522.
42. Vestbo J, Vogelmeier C, Creemers J, Falques M, Ribera A, Gil EG. Onset of effect of aclidinium, a novel, long-acting muscarinic antagonist, in patients with COPD. Chronic Obstr Pulm Dis. 2010;7(5):331–336.
43. Magnussen H, Watz H, Zimmermann I, et al. Peak inspiratory fow through the Genuair inhaler in patients with moderate or severe COPD. Respir Med. 2009;103(12):1832–1837.
44. Newman SP, Sutton DJ, Segarra R, Lamarca R, de Miquel G. Lung deposition of aclidinium bromide from Genuair, a multidose dry powder inhaler. Respiration. 2009;78(3):322–328.
45. van der Palen J, Ginko T, Kroker A, et al. Preference, satisfaction and errors with two dry powder inhalers in patients with COPD. Expert Opin Drug Deliv. 2013;10(8):1023–1031.
46. Ismaila A, Corriveau D, Vaillancourt J, et al. Impact of adherence to treatment with tiotropium and futicasone propionate/salmeterol in chronic obstructive pulmonary diseases patients. Curr Med Res Opin. 2014;30(7):1427–1436.
47. Laforest L, Licaj I, Devouassoux G, Hartwig S, Marvalin S, Van Ganse E. Factors associated with early adherence to tiotropium in chronic obstructive pulmonary disease. Chron Respir Dis. 2013;10(1):11–18.
48. Wurst KE, St Laurent S, Mullerova H, Davis KJ. Characteristics of patients with COPD newly prescribed a long-acting bronchodilator: a retrospective cohort study. Int J Chron Obstruct Pulmon Dis. 2014; 9:1021–1031.
49. de Miguel-Díez J, Jiménez-García R, Hernández-Barrera V, et al. Clustering of unhealthy lifestyle behaviors is associated with a low adherence to recommended preventive practices among COPD patients in Spain. Chronic Obstr Pulm Dis. 2014;11(4):459–467.
50. Vestbo J, Anderson JA, Calverley PM, et al. Adherence to inhaled therapy, mortality and hospital admission in COPD. Thorax. 2009; 64(11):939–943.
51. van Boven JF, Tommelein E, Boussery K, et al. Improving inhaler adherence in patients with chronic obstructive pulmonary disease: a cost-effectiveness analysis. Respir Res. 2014;15:66.
52. Huetsch JC, Uman JE, Udris EM, Au DH. Predictors of adherence to inhaled medications among veterans with COPD. J Gen Intern Med. 2012;27(11):1506–1512.
53. Chrystyn H, Small M, Milligan G, Higgins V, Gil EG, Estruch J. Impact of patients’ satisfaction with their inhalers on treatment compliance and health status in COPD. Respir Med. 2014;108(2):358–365.
54. 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):486–496.
55. Agh T, Inotai A, Meszaros A. Factors associated with medication adherence in patients with chronic obstructive pulmonary disease. Respiration. 2011;82(4):328–334.
56. Trivedi RB, Bryson CL, Udris E, Au DH. The infuence of informal caregivers on adherence in COPD patients. Ann Behav Med. 2012; 44(1):66–72.
57. Cecere LM, Slatore CG, Uman JE, et al. Adherence to long-acting inhaled therapies among patients with chronic obstructive pulmonary disease (COPD). Chronic Obstr Pulm Dis. 2012;9(3):251–258.
58. Khdour MR, Hawwa AF, Kidney JC, Smyth BM, McElnay JC. Potential risk factors for medication non-adherence in patients with chronic obstructive pulmonary disease (COPD). Eur J Clin Pharmacol. 2012; 68(10):1365–1373.
59. Viswanathan M, Golin CE, Jones CD, et al. Interventions to improve adherence to self-administered medications for chronic diseases in the United States: a systematic review. Ann Intern Med. 2012;157(11): 785–795.
60. Borg GA. Perceived exertion: a note on “history” and methods. Med Sci Sports. 1973;5(2):90–93.
61. Gift AG. Validation of a vertical visual analogue scale as a measure of clinical dyspnea. Rehabil Nurs. 1989;14(6):323–325.
62. Guyatt GH, Berman LB, Townsend M, Pugsley SO, Chambers LW. A measure of quality of life for clinical trials in chronic lung disease. Thorax. 1987;42(10):773–778.
63. Jones PW, Quirk FH, Baveystock CM. The St George’s respiratory questionnaire. Respir Med. 1991;85(suppl B):25–31; discussion 33–37.
64. Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and frst validation of the COPD assessment test. Eur Respir J. 2009;34(3):648–654.
65. van der Molen T, Willemse BW, Schokker S, ten Hacken NH, Postma DS, Juniper EF. Development, validity and responsiveness of the clinical COPD questionnaire. Health Qual Life Outcomes. 2003; 1:13.
66. Hernandez P, Balter M, Bourbeau J, Hodder R. Living with chronic obstructive pulmonary disease: a survey of patients’ knowledge and attitudes. Respir Med. 2009;103(7):1004–1012.
67. Partridge MR, Miravitlles M, Stahl E, Karlsson N, Svensson K, Welte T. Development and validation of the capacity of daily living during the morning questionnaire and the global chest symptoms questionnaire in COPD. Eur Respir J. 2010;36(1):96–104.
68. Pommer AM, Prins L, van Ranst D, et al. Development and validity of the patient-centred COPD questionnaire (PCQ). J Psychosom Res. 2013;75(6):563–571.
69. Birring SS, Prudon B, Carr AJ, Singh SJ, Morgan MD, Pavord ID. Development of a symptom specific health status measure for patients with chronic cough: Leicester Cough Questionnaire (LCQ). Thorax. 2003;58(4):339–343.
70. Pokrzywinski RF, Meads DM, McKenna SP, Glendenning GA, Revicki DA. Development and psychometric assessment of the COPD and Asthma Sleep Impact Scale (CASIS). Health Qual Life Outcomes. 2009;7:98.
71. Hareendran A, Palsgrove AC, Mocarski M, et al. The development of a patient-reported outcome measure for assessing nighttime symptoms of chronic obstructive pulmonary disease. Health Qual Life Outcomes. 2013;11:104.
72. Fisk JD, Ritvo PG, Ross L, Haase DA, Marrie TJ, Schlech WF. Measuring the functional impact of fatigue: initial validation of the fatigue impact scale. Clin Infect Dis. 1994;18(suppl 1):S79–S83.
73. Al-shair K, Kolsum U, Berry P, et al. Development, dimensions, reliability and validity of the novel Manchester COPD fatigue scale. Thorax. 2009;64(11):950–955.
74. Whitehead L. The measurement of fatigue in chronic illness: a systematic review of unidimensional and multidimensional fatigue measures. J Pain Symptom Manage. 2009;37(1):107–128.
75. Parshall MB, Schwartzstein RM, Adams L, et al; American Thoracic Society Committee on Dyspnea. An offcial American Thoracic Society statement: update on the mechanisms, assessment, and management of dyspnea. Am J Respir Crit Care Med. 2012;185(4):435–452.
76. Weldam SW, Schuurmans MJ, Liu R, Lammers J W. Evaluation of Quality of Life instruments for use in COPD care and research: a systematic review. Int J Nurs Stud. 2013;50(5):688–707.