Single inhaler extrafine triple therapy versus long-acting muscarinic antagonist therapy for chronic obstructive pulmonary disease (TRINITY): a double-blind, parallel group, randomised controlled trial

The Lancet

Volumn 389, Issue 10082, 2017, Pages 1919-1929

  Vestbo, Jørgen ^a,b,h   Papi, Alberto ^c   Corradi, Massimo ^d   Blazhko, Viktor ^e   Montagna, Isabella ^f   Francisco, Catherine ^g   Cohuet, Géraldine ^g   Vezzoli, Stefano ^f   Scuri, Mario ^f   Singh, Dave ^a,b,h  

^a UNIVERSITY OF MANCHESTER   (United Kingdom)

^b MANCHESTER UNIVERSITY NHS FOUNDATION TRUST   (United Kingdom)

^c UNIVERSITY OF FERRARA   (Italy)

^d UNIVERSITY OF PARMA   (Italy)

^e Kharkiv City Hospital center of the cerebro vascular diseases   (Ukraine)

^f CHIESI FARMACEUTICI S P A   (Italy)

^g Laboratoire Chiesi   (France)

^h Medicines Evaluation Unit   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE; BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE PLUS GLYCOPYRRONIUM BROMIDE; SALBUTAMOL; TIOTROPIUM BROMIDE; BECLOMETASONE; BRONCHODILATING AGENT; FORMOTEROL FUMARATE; GLUCOCORTICOID; GLYCOPYRRONIUM; MUSCARINIC RECEPTOR BLOCKING AGENT;

ACUTE CORONARY SYNDROME; ADULT; AIRFLOW; ANGINA PECTORIS; ARTICLE; CARDIOVASCULAR DISEASE; CHRONIC OBSTRUCTIVE LUNG DISEASE; CONTROLLED STUDY; CORONARY ARTERY DISEASE; COUGHING; DISEASE EXACERBATION; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRY POWDER INHALER; DYSPHONIA; DYSPNEA; FEMALE; FORCED EXPIRATORY VOLUME; HEADACHE; HEART FAILURE; HEART INFARCTION; HEART MUSCLE ISCHEMIA; HUMAN; ISCHEMIC CARDIOMYOPATHY; ISCHEMIC HEART DISEASE; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MUSCLE SPASM; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; THRUSH; TREATMENT OUTCOME; VIRAL RESPIRATORY TRACT INFECTION; XEROSTOMIA; AGED; COMPARATIVE STUDY; INHALATIONAL DRUG ADMINISTRATION; NEBULIZER;

ADMINISTRATION, INHALATION; ADULT; AGED; BECLOMETHASONE; BRONCHODILATOR AGENTS; DOUBLE-BLIND METHOD; FEMALE; FORCED EXPIRATORY VOLUME; FORMOTEROL FUMARATE; GLUCOCORTICOIDS; GLYCOPYRROLATE; HUMANS; MALE; MIDDLE AGED; MUSCARINIC ANTAGONISTS; NEBULIZERS AND VAPORIZERS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; TIOTROPIUM BROMIDE;

EID: 85017388033     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(17)30188-5     Document Type: Article

References (26)

1. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. www.goldcopd.org, 2016 (accessed July 22, 2016).
2. Solem, CT, Sun, SX, Sudharshan, L, Macahilig, C, Katyal, M, Gao, X, Exacerbation-related impairment of quality of life and work productivity in severe and very severe chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis 8 (2013), 641–652.
3. Celli, BR, Thomas, NE, Anderson, JA, 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 178 (2008), 332–338.
4. Donaldson, GC, Seemungal, TAR, Bhowmik, A, Wedzicha, JA, Relationship between exacerbation frequency and lung function decline in chronic obstructive pulmonary disease. Thorax 57 (2002), 847–852.
5. Johannesdottir, SA, Christiansen, CF, Johansen, MB, et al. Hospitalization with acute exacerbation of chronic obstructive pulmonary disease and associated health resource utilization: a population-based Danish cohort study. J Med Econ 16 (2013), 897–906.
6. National Institute for Health and Care Excellence. Chronic obstructive pulmonary disease in over 16s: diagnosis and management. https://www.nice.org.uk/guidance/cg101/resources/chronic-obstructive-pulmonary-disease-in-over-16s-diagnosis-and-management-35109323931589, 2010 (accessed Sept 13, 2016).
7. Welte, T, Miravitlles, M, Hernandez, P, et al. Efficacy and tolerability of budesonide/formoterol added to tiotropium in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 180 (2009), 741–750.
8. Lee, S-D, Xie, C-M, Yunus, F, et al. Efficacy and tolerability of budesonide/formoterol added to tiotropium compared with tiotropium alone in patients with severe or very severe COPD: A randomized, multicentre study in East Asia. Respirology 21 (2016), 119–127.
9. Jenkins, CR, Celli, B, Anderson, JA, et al. Seasonality and determinants of moderate and severe COPD exacerbations in the TORCH study. Eur Respir J 39 (2012), 38–45.
10. Aaron, SD, Vandemheen, KL, Fergusson, D, et al. Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial. Ann Intern Med 146 (2007), 545–555.
11. De Backer, W, Devolder, A, Poli, G, et al. Lung deposition of BDP/formoterol HFA pMDI in healthy volunteers, asthmatic, and COPD Patients. J Aerosol Med Pulm Drug Deliv 23 (2010), 137–148.
12. Jones, PW, Beeh, KM, Chapman, KR, Decramer, M, Mahler, DA, Wedzicha, JA, Minimal clinically important differences in pharmacological trials. Am J Respir Crit Care Med 189 (2014), 250–255.
13. European Medicines Agency. Guideline on clinical investigation of medicinal products in the treatment of chronic obstructive pulmonary disease (COPD) (EMA/CHMP/483572/2012). London, UK, 2012.
14. Decramer, ML, Chapman, KR, Dahl, R, 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 1 (2013), 524–533.
15. Vestbo, J, Leather, D, Diar Bakerly, N, et al. Effectiveness of fluticasone furoate–vilanterol for COPD in clinical practice. N Engl J Med 375 (2016), 1253–1260.
16. Magnussen, H, Disse, B, Rodriguez-Roisin, R, et al. Withdrawal of inhaled glucocorticoids and exacerbations of COPD. N Engl J Med 371 (2014), 1285–1294.
17. Martinez, FJ, Calverley, PMA, Goehring, U-M, Brose, M, Fabbri, LM, Rabe, KF, Effect of roflumilast on exacerbations in patients with severe chronic obstructive pulmonary disease uncontrolled by combination therapy (REACT): a multicentre randomised controlled trial. Lancet 385 (2015), 857–866.
18. 2-Agonist on Chronic Obstructive Pulmonary Disease Exacerbations (RE2SPOND). A randomized clinical trial. Am J Respir Crit Care Med 194 (2016), 559–567.
19. 2-agonist therapy for chronic obstructive pulmonary disease (TRILOGY): a double-blind, parallel group, randomised controlled trial. Lancet 388 (2016), 963–973.
20. Wedzicha, JA, Banerji, D, Chapman, KR, et al. Indacaterol-glycopyrronium versus salmeterol-fluticasone for COPD. N Engl J Med 374 (2016), 2222–2234.
21. Brusselle, G, Price, D, Gruffydd-Jones, K, et al. The inevitable drift to triple therapy in COPD: an analysis of prescribing pathways in the UK. Int J Chron Obstruct Pulmon Dis 10 (2015), 2207–2217.
22. 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 192 (2015), 523–525.
23. 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 3 (2015), 435–442.
24. Barnes, NC, Sharma, R, Lettis, S, Calverley, PMA, Blood eosinophils as a marker of response to inhaled corticosteroids in COPD. Eur Respir J 47 (2016), 1374–1382.
25. Vedel-Krogh, S, Nielsen, SF, Lange, P, Vestbo, J, Nordestgaard, BG, Blood eosinophils and exacerbations in COPD: the Copenhagen General Population Study. Am J Respir Crit Care Med 193 (2016), 965–974.
26. Kew, KM, Seniukovich, A, Inhaled steroids and risk of pneumonia for chronic obstructive pulmonary disease. Cochrane Database Syst Rev, 3, 2014 CD010115.