Effect of Aclidinium Bromide on Exacerbations in Patients with Moderate-to-Severe COPD: A Pooled Analysis of Five Phase III, Randomized, Placebo-Controlled Studies

References

• Celli BR, Thomas NE, Anderson JA, Ferguson GT, Jenkins CR, Jones PW, et al. Effect of pharmacotherapy on rate of decline of lung function in chronic obstructive pulmonary disease: results from the TORCH study. Am J Respir Crit Care Med 2008;178:332–338.
   PubMed Web of Science ®Google Scholar
• Donaldson GC, Seemungal TA, Bhowmik A, Wedzicha JA. Relationship between exacerbation frequency and lung function decline in chronic obstructive pulmonary disease. Thorax 2002;57:847–852.
   PubMed Web of Science ®Google Scholar
• Kanner RE, Anthonisen NR, Connett JE. Lower respiratory illnesses promote FEV(1) decline in current smokers but not ex-smokers with mild chronic obstructive pulmonary disease: results from the lung health study. Am J Respir Crit Care Med 2001;164:358–364.
   PubMed Web of Science ®Google Scholar
• Vestbo J, Agusti A, Wouters EF, Bakke P, Calverley PM, Celli B, et al. Should we view chronic obstructive pulmonary disease differently after ECLIPSE? A clinical perspective from the study team. Am J Respir Crit Care Med 2014;189:1022–1030.
   PubMed Web of Science ®Google Scholar
• Jones PW, Lamarca R, Chuecos F, Singh D, Agusti A, Bateman ED, et al. Characterisation and impact of reported and unreported exacerbations: results from ATTAIN. Eur Respir J 2014;44:1156–1165.
   PubMed Web of Science ®Google Scholar
• Seemungal TA, Donaldson GC, Paul EA, Bestall JC, Jeffries DJ, Wedzicha JA. Effect of exacerbation on quality of life in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 1998;157:1418–1422.
   PubMed Web of Science ®Google Scholar
• Xu W, Collet JP, Shapiro S, Lin Y, Yang T, Wang C, et al. Negative impacts of unreported COPD exacerbations on health-related quality of life at 1 year. Eur Respir J 2010;35:1022–1030.
   PubMed Web of Science ®Google Scholar
• Soler-Cataluna JJ, Martinez-Garcia MA, Roman SP, Salcedo E, Navarro M, Ochando R. Severe acute exacerbations and mortality in patients with chronic obstructive pulmonary disease. Thorax 2005;60:925–931.
   PubMed Web of Science ®Google Scholar
• Wouters EF. Economic analysis of the confronting COPD survey: an overview of results. Respir Med 2003;97 Suppl C:S3–S14.
   PubMed Web of Science ®Google Scholar
• Miravitlles M, Garcia-Polo C, Domenech A, Villegas G, Conget F, de la Roza C. Clinical outcomes and cost analysis of exacerbations in chronic obstructive pulmonary disease. Lung 2013;191:523–530.
   PubMed Web of Science ®Google Scholar
• Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease [Internet]. [updated 2015; cited 2015 Mar 30]. Available from: http://www.goldcopd.org/uploads/users/files/GOLD_Report_2015_Feb18.pdf.
   Google Scholar
• Tashkin DP, 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 2008;359:1543–1554.
   PubMed Web of Science ®Google Scholar
• Buhl R, Banerji D. Profile of glycopyrronium for once-daily treatment of moderate-to-severe COPD. Int J Chron Obstruct Pulmon Dis 2012;7:729–741.
   PubMed Web of Science ®Google Scholar
• Decramer ML, Chapman KR, Dahl R, Frith P, Devouassoux G, Fritscher C, et al. Once-daily indacaterol versus tiotropium for patients with severe chronic obstructive pulmonary disease (INVIGORATE): a randomised, blinded, parallel-group study. Lancet Respir Med 2013;1:524–533.
   PubMed Web of Science ®Google Scholar
• Vogelmeier C, Hederer B, Glaab T, Schmidt H, Rutten-van Molken MPMH, Beeh KM, et al. Tiotropium versus salmeterol for the prevention of exacerbations of COPD. N Engl J Med 2011;364:1093–1103.
   PubMed Web of Science ®Google Scholar
• AstraZeneca PLC. Summary of product characteristics Eklira Genuair 322 μg inhalation powder [Internet]. [updated 2015 Apr 28; cited 2015 May 7]. Available from: http://www.medicines.org.uk/emc/medicine/27001/.
   Google Scholar
• Jones PW, Singh D, Bateman ED, Agusti A, Lamarca R, de Miquel G, et al. Efficacy and safety of twice-daily aclidinium bromide in COPD patients: the ATTAIN study. Eur Respir J 2012;40:830–836.
   PubMed Web of Science ®Google Scholar
• Kerwin EM, D'Urzo AD, Gelb AF, Lakkis H, Garcia Gil E, Caracta CF, et al. Efficacy and safety of a 12-week treatment with twice-daily aclidinium bromide in COPD patients (ACCORD COPD I). COPD 2012;9:90–101.
   PubMedGoogle Scholar
• Rennard SI, Scanlon PD, Ferguson GT, Rekeda L, Maurer BT, Garcia Gil E, 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;33:893–904.
   PubMed Web of Science ®Google Scholar
• Singh D, Jones PW, Bateman ED, 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 2014;14:178.
   PubMed Web of Science ®Google Scholar
• Bateman E, Rennard S, Jones P, Molins E, Jin M, Leselbaum A. Effect of aclidinium bromide/formoterol fumarate fixed-dose combination (FDC) on exacerbations in moderate-to-severe COPD: Pooled analysis of two studies. Eur Respir J 2014;44:285.
   Google Scholar
• D'Urzo AD, Rennard SI, Kerwin EM, Mergel V, Leselbaum AR, Caracta CF. Efficacy and safety of fixed-dose combinations of aclidinium bromide/formoterol fumarate: the 24-week, randomized, placebo-controlled AUGMENT COPD study. Respir Res 2014;15:123.
   PubMed Web of Science ®Google Scholar
• Han MK, Muellerova H, Curran-Everett D, Dransfield MT, Washko GR, Regan EA, et al. GOLD 2011 disease severity classification in COPDGene: a prospective cohort study. Lancet Respir Med 2013;1:43–50.
   PubMed Web of Science ®Google Scholar
• Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease [Internet]. [updated 2014 Jan; cited 2014 Nov 12]. Available from: http://www.goldcopd.com/guidelines-global-strategy-for-diagnosis-management.html.
   Google Scholar
• Dusser D, Bravo ML, Iacono P. The effect of tiotropium on exacerbations and airflow in patients with COPD. Eur Respir J 2006;27:547–555.
   PubMed Web of Science ®Google Scholar
• 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;7:562.
   PubMedGoogle Scholar
• Kim S, Oh J, Kim YI, Ban HJ, Kwon YS, Oh IJ, et al. Differences in classification of COPD group using COPD assessment test (CAT) or modified Medical Research Council (mMRC) dyspnea scores: a cross-sectional analyses. BMC Pulm Med 2013;13:35.
   PubMed Web of Science ®Google Scholar
• Holt S, Sheahan D, Helm C, Tofield C, Corin A, Kocks JW. Little agreement in GOLD category using CAT and mMRC in 450 primary care COPD patients in New Zealand. NPJ Prim Care Respir Med 2014;24:14025.
   PubMed Web of Science ®Google Scholar
• Agusti A, Hurd S, Jones P, Fabbri LM, Martinez F, Vogelmeier C, et al. FAQs about the GOLD 2011 assessment proposal of COPD: a comparative analysis of four different cohorts. Eur Respir J 2013;42:1391–1401.
   PubMed Web of Science ®Google Scholar
• Wedzicha JA, Decramer M, Seemungal TA. The role of bronchodilator treatment in the prevention of exacerbations of COPD. Eur Respir J 2012;40:1545–1554.
   PubMed Web of Science ®Google Scholar
• Karner C, Chong J, Poole P. Tiotropium versus placebo for chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2012;7:CD009285.
   PubMed Web of Science ®Google Scholar
• Bateman ED, Chapman KR, Singh D, D'Urzo AD, Molins E, Leselbaum, A, et al. Aclidinium bromide and formoterol fumarate as a fixed-dose combination in COPD: pooled analysis of symptoms and exacerbations from two six-month, multicentre, randomised studies (ACLIFORM and AUGMENT). Respir Res 2015;16:92.
   PubMed Web of Science ®Google Scholar