FAQ References

Could the results from FLAME be considered a long-acting β2-agonist/long-acting muscarinic antagonist (LABA/LAMA) class effect?

  1. Wedzicha JA, Banerji D, Chapman KR, et al. Indacaterol-glycopyrronium versus salmeterol-fluticasone for COPD. N Engl J Med 2016;374:2222–34.
  2. Cazzola M, Molimard M. The scientific rationale for combining long-acting b2-agonists and muscarinic antagonists in COPD. Pulm Pharmacol Ther 2010;23:257–67.
  3. Cazzola M, Beeh KM, Price D, Roche N. Assessing the clinical value of fast onset and sustained duration of action of long-acting bronchodilators for COPD. Pulm Pharmacol Ther 2015;31:6878.
  4. Bateman ED, Ferguson GT, Barnes N, et al. Dual bronchodilation with QVA149 versus single bronchodilator therapy: the SHINE study. Eur Respir J 2013;42:148494.
  5. Wedzicha JA, Decramer M, Ficker JH, 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 2013;1:199209.
  6. Donohue JF, Maleki-Yazdi MR, Kilbride S, et al. Efficacy and safety of once-daily umeclidinium/vilanterol 62.5/25 mg in COPD. Respir Med 2013;107:153846.
  7. Decramer M, Anzueto A, Kerwin E, 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 2014;2:47286.
  8. Singh D, Jones PW, Bateman ED, 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.
  9. D'Urzo AD, Rennard SI, Kerwin EM, et al. 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.
  10. Buhl R, Maltais F, Abrahams R, et al. Tiotropium and olodaterol fixed-dose combination versus mono-components in COPD (GOLD 2–4). Eur Respir J 2015;45:96979.
  11. Beeh KM, Westerman J, Kirsten AM, 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 2015;32:539.

Most exacerbation studies in COPD focus on moderate or severe exacerbations. Why did FLAME include all (mild/moderate/severe) exacerbations as the primary endpoint instead?

  1. Wilkinson TM, Donaldson GC, Hurst JR, Seemungal TA, Wedzicha JA. Early therapy improves outcomes of exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2004;169:1298303.
  2. Langsetmo L, Platt RW, Ernst P, Bourbeau J. Underreporting exacerbation of chronic obstructive pulmonary disease in a longitudinal cohort. Am J Respir Crit Care Med 2008;177:396401.
  3. Jones PW, Lamarca R, Chuecos F, et al. Characterisation and impact of reported and unreported exacerbations: results from ATTAIN. Eur Respir J 2014;44:115665.
  4. Wedzicha JA, Banerji D, Chapman KR, et al. Indacaterol-glycopyrronium versus salmeterol-fluticasone for COPD. N Engl J Med 2016;374:222234.
  5. Wedzicha JA, Decramer M, Ficker JH, 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 2013;1:199209.

Why is the time-to-first exacerbation studied in clinical trials?

  1. Keene ON, Calverley PM, Jones PW, Vestbo J, Anderson JA. Statistical analysis of exacerbation rates in COPD: TRISTAN and ISOLDE revisited. Eur Respir J 2008;32:1724.
  2. Aaron SD, Fergusson D, Marks GB, et al. Counting, analysing and reporting exacerbations of COPD in randomised controlled trials. Thorax 2008;63:1228.
  3. Beeh KM, Hederer B, Glaab T, et al. Study design considerations in a large COPD trial comparing effects of tiotropium with salmeterol on exacerbations. Int J Chron Obstruct Pulmon Dis 2009;4:11925.

In which patients do you think inhaled corticosteroids (ICS) treatment should be withdrawn?

  1. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2017. Available at: http://goldcopd.org/gold-2017-global-strategy-diagnosis-management-prevention-copd/. Last accessed 3 January 2017. 
  2. Suissa S, Rossi A. Weaning from inhaled corticosteroids in COPD: the evidence. Eur Respir J 2015;46:1232–5.
  3. Kaplan A, Roman-Rodriguez M, Price D, Tsiligianni I. Evaluation of appropriateness of inhaled corticosteroid (ICS) therapy in COPD and guidance on ICS withdrawal. 2017;No. 6.
  4. Rossi A, van der Molen T, del Olmo R, et al. INSTEAD: a randomised switch trial of indacaterol versus salmeterol/fluticasone in moderate COPD. Eur Respir J 2014;44:154856.
  5. Magnussen H, Disse B, Rodriguez-Roisin R, et al. Withdrawal of inhaled glucocorticoids and exacerbations of COPD. N Engl J Med 2014;371:128594.
  6. Magnussen H, Tetzlaff K, Bateman ED, et al. Lung function changes over time following withdrawal of inhaled corticosteroids in patients with severe COPD. Eur Respir J 2016;47:6514.

Analyses of WISDOM data suggest ICS withdrawal increased exacerbation risk in a certain subset of patients. What proportion of patients in clinical practice have these characteristics?

  1. Calverley PM, Tetzlaff K, Vogelmeier C, et al. Eosinophilia, frequent exacerbations, and steroid response in chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2017:doi: 10.1164/rccm.201612-2525LE [Epub ahead of print].
  2. Magnussen H, Disse B, Rodriguez-Roisin R, et al. Withdrawal of inhaled glucocorticoids and exacerbations of COPD. N Engl J Med 2014;371:1285–94.
  3. Lange P, Marott JL, Vestbo J, et al. Prediction of the clinical course of chronic obstructive pulmonary disease, using the new GOLD classification: a study of the general population. Am J Respir Crit Care Med 2012;186:97581.
  4. Han MK, Muellerova H, Curran-Everett D, et al. GOLD 2011 disease severity classification in COPDGene: a prospective cohort study. Lancet Respir Med 2013;1:4350.
  5. Agusti A, Hurd S, Jones P, et al. FAQs about the GOLD 2011 assessment proposal of COPD: a comparative analysis of four different cohorts. Eur Respir J 2013;42:1391401.
  6. Haughney J, Gruffydd-Jones K, Roberts J, et al. The distribution of COPD in UK general practice using the new GOLD classification. Eur Respir J 2014;43:9931002.
  7. Hurst JR, Vestbo J, Anzueto A, et al. Susceptibility to exacerbation in chronic obstructive pulmonary disease. N Engl J Med 2010;363:112838.
  8. DiSantostefano RL, Hinds D, Van Le H, Barnes NC. Relationship between blood eosinophils and clinical characteristics in a cross-sectional study of a US population-based COPD cohort. Respir Med 2016.
  9. Millett ERC, Brightling CE, Pavord I, Russell R, Bafadhel M. The stability of blood eosinophils in stable COPD patients and validity of using baseline eosinophil values to determine eosinophilia in epidemiological studies. Am J Respir Crit Care Med 2016;193:A6325.
  10. Tran T, Caspard H, Ward C, van de Merwe R. Distribution of blood eosinophil in COPD patients. Eur Respir J 2014;44 (Suppl 58):P4765.

How do you identify COPD patients who would benefit from inhaled corticosteroid (ICS) treatment?

  1. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2017. Available at: http://goldcopd.org/gold-2017-global-strategy-diagnosis-management-prevention-copd/. Last accessed 3 January 2017. 
  2. Kostikas K, Clemens A, Patalano F. The asthma-COPD overlap syndrome: do we really need another syndrome in the already complex matrix of airway disease? Int J Chron Obstruct Pulmon Dis 2016;11:1297–306.
  3. Pascoe S, Locantore N, Dransfield MT, Barnes NC, Pavord ID. Blood eosinophil counts, exacerbations, and response to the addition of inhaled fluticasone furoate to vilanterol in patients with chronic obstructive pulmonary disease: a secondary analysis of data from two parallel randomised controlled trials. Lancet Respir Med 2015;3:43542.
  4. Siddiqui SH, Guasconi A, Vestbo J, et al. Blood eosinophils: a biomarker of response to extrafine beclomethasone/formoterol in chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2015;192:5235.
  5. Pavord ID, Lettis S, Locantore N, et al. Blood eosinophils and inhaled corticosteroid/long-acting beta-2 agonist efficacy in COPD. Thorax 2016;71:11825.
  6. Wedzicha JA, Banerji D, Chapman KR, et al. Indacaterol-glycopyrronium versus salmeterol-fluticasone for COPD. N Engl J Med 2016;374:222234.
  7. Roche N, Chapman KR, Vogelmeier CF, et al. Blood eosinophils and response to maintenance COPD treatment: data from the FLAME trial. Am J Respir Crit Care Med 2017;195:118997.
  8. Magnussen H, Disse B, Rodriguez-Roisin R, et al. Withdrawal of inhaled glucocorticoids and exacerbations of COPD. N Engl J Med 2014;371:128594.
  9. Watz H, Tetzlaff K, Wouters EF, et al. Blood eosinophil count and exacerbations in severe chronic obstructive pulmonary disease after withdrawal of inhaled corticosteroids: a post-hoc analysis of the WISDOM trial. Lancet Respir Med 2016;4:3908.
  10. Calverley PM, Tetzlaff K, Vogelmeier C, et al. Eosinophilia, frequent exacerbations, and steroid response in chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2017:doi: 10.1164/rccm.201612-2525LE [Epub ahead of print].

 

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