Long-acting muscarinic antagonists (LAMA) added to inhaled corticosteroids (ICS) versus higher dose ICS for adults with asthma

Cochrane Database of Systematic Reviews

Volumn 2015, Issue 7, 2015, Pages

  Evans, David J W ^a   Kew, Kayleigh M ^b   Anderson, Debbie E ^c   Boyter, Anne C ^c  

^a ROYAL LANCASTER INFIRMARY   (United Kingdom)

^b ST GEORGE S HOSPITAL   (United Kingdom)

^c UNIVERSITY OF STRATHCLYDE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ACLIDINIUM BROMIDE; CORTICOSTEROID; FORMOTEROL; GLYCOPYRRONIUM; LONG ACTING DRUG; MUSCARINIC RECEPTOR BLOCKING AGENT; SALMETEROL; TIOTROPIUM BROMIDE; ANTIASTHMATIC AGENT; BECLOMETASONE;

ASTHMA; CLINICAL PRACTICE; DISEASE CONTROL; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG MEGADOSE; DRUG SAFETY; FORCED EXPIRATORY VOLUME; FORCED VITAL CAPACITY; HOSPITALIZATION; HUMAN; LUNG FUNCTION TEST; PEAK EXPIRATORY FLOW; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY OF LIFE ASSESSMENT; REVIEW; SYSTEMATIC REVIEW; UNSPECIFIED SIDE EFFECT; ADULT; CROSSOVER PROCEDURE; INHALATIONAL DRUG ADMINISTRATION; RANDOMIZED CONTROLLED TRIAL (TOPIC);

ADMINISTRATION, INHALATION; ADRENAL CORTEX HORMONES; ADULT; ANTI-ASTHMATIC AGENTS; ASTHMA; BECLOMETHASONE; CROSS-OVER STUDIES; HUMANS; MUSCARINIC ANTAGONISTS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TIOTROPIUM BROMIDE;

EID: 84955280277     PISSN: None     EISSN: 1469493X     Source Type: Journal    
DOI: 10.1002/14651858.CD011437.pub2     Document Type: Review

References (82)

1. Lane M. Tiotropium bromide in asthma patients: an alternative to inhaled long-acting beta-agonists?. Journal of the Royal College of Physicians of Edinburgh 2010;40(4):321-2.
2. NCT00565266. Asthma Clinical Research Network (ACRN) Trial - Tiotropium bromide as an alternative to increased inhaled corticosteroid in patients inadequately controlled on a lower dose of inhaled corticosteroid (TALC). http://clinicaltrials.gov/show/NCT00565266 (accessed 19 January 2015).
3. Peters SP, Bleecker ER, Kunselman SJ, Icitovic N, Moore WC, Pascual R, et al. Predictors of response to tiotropium versus salmeterol in asthmatic adults. The Journal of Allergy and Clinical Immunology 2013;132(5):1068-74.
4. Peters SP, Kunselman SJ, Icitovic N, Moore WC, Pascual R, Ameredes BT, et al. Tiotropium bromide step-up therapy for adults with uncontrolled asthma. New England Journal of Medicine 2010;363(18):1715-26.
5. Beeh KM, Ablinger O, Moroni-Zentgraf P, Hollaenderova Z, Pivovarova A, Engel M, et al. Once-daily add-on tiotropium: A dose-finding trial in adult patients with moderate persistent asthma [Abstract]. Allergy 2013;68(s97):376-7.
6. 2-agonists [Abstract]. Chest 2013;144(4 Meeting Abstracts):89A.
7. H2 inflammatory status [Abstract]. The Journal of Allergy and Clinical Immunology 2014;133(2 Suppl):AB5.
8. Casale TB, Bleecker ER, Meltzer E, Pizzichini E, Schmidt O, Bateman ED, et al. Phase III trials to investigate tiotropium as add-on therapy to inhaled corticosteroids for patients with symptomatic asthma: trial design and planned statistical analyses [Abstract]. Allergy 2013;68(Suppl 97):377.
9. Corren J, Murphy KR, Bensch G, Dahl R, Paggiaro P, Engel M, et al. Once-daily tiotropium respimat decreases the risk of exacerbations, independent of baseline characteristics, in patients with symptomatic severe asthma without evidence of chronic obstructive pulmonary disease. Journal of General Internal Medicine 2014;29:S157-8.
10. CTRI/2008/091/000306. A randomized, double-blind, crossover, non-inferiority study comparing bronchodilator effects of single dose of 18 mcg of Tiotropium Bromide and two doses of 12 mcg of formoterol fumarate each over 24 hours in subjects with moderate to severe asthma. http://www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=284&EncHid=&modid=&compid=%27, %27284det%27 (accessed 19 January 2015).
11. CTRI/2012/08/002915. Assessment of various second line treatment regimens on mild to moderate persistent asthmatic patients. http://www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=5059&EncHid=&modid=&compid=%27, %275059det%27 (accessed 19 January 2015).
12. Dahl R, Doherty DE, Corren J, Karpel J, Kerstjens HAM, Engel M, et al. Once-daily tiotropium respimat improves lung function in patients with severe symptomatic asthma independent of leukotriene modifier use [Abstract]. The Journal of Allergy and Clinical Immunology 2014;133(2 Suppl):AB5.
13. Dahl R, Bateman ED, Casale TB, Pizzichini E, Vandewalker M, Virchow JC, et al. Once-daily tiotropium Respimat as add-on to at least medium- to high-dose ICS, with or without LABA, improves lung function in patients with symptomatic asthma, independent of allergic status [Abstract]. 33rd Congress of the European Academy of Allergy and Clinical Immunology; 2014 June 7-11; Copenhagen. 2014.
14. Doherty DE, Tashkin DP, Harrison TW, Engel M, Schmidt H, Moroni-Zentgraf P, et al. Improvements in lung function with tiotropium as add-on controller therapy to ICS+LABA for patients with symptomatic severe asthma [Abstract]. Chest 2013;144(4 Meeting Abstracts):88A.
15. EUCTR2006-003385-34-NL. The effect of tiotropium-bromide on deep inspiration-induced bronchodilation and airway responsiveness in asthma. https://www.clinicaltrialsregister.eu/ctr-search/trial/2006-003385-34/NL/#A (accessed 19 January 2015).
16. Haggart K, Fardon TC, Lee DKC, Lipworth BJ. Stepping down inhaled steroids in severe asthma with long acting bronchodilators: utilising effort dependent and independent measures of pulmonary function [Abstract]. Thorax 2004;59(Suppl 2):ii72.
17. Halpin DMG, Bateman ED, Tashkin DP, Engel M, Dahl R, Paggiaro P, et al. Tiotropium decreases the risk of exacerbations in patients with symptomatic asthma regardless of baseline characteristics including markers of allergic status [Abstract]. Thorax 2013;68(Suppl 3):A149.
18. Hozawa S, Kerstjens HAM, Tashkin DP, Engel M, Ronald D, Paggiaro P, et al. Tiotropium decreases the risk of exacerbations in patients with symptomatic asthma regardless of baseline characteristics [Abstract]. Respirology 2013;18(S4):175.
19. JPRN-UMIN000010352. Study for effects of tiotropium on smokers and non-smokers with bronchial asthma. http://www.umin.ac.jp/ctr/index.htm (accessed 19 January 2015).
20. Corren J, Frew A, Engel M, Schmidt H, Moroni-Zentgraf P, Kerstjens HAM. Tiotropium as add-on therapy to ICS+LABA in patients with symptomatic severe asthma: spirometric assessment over 24 hours [Abstract]. Chest 2013;144(4 Meeting Abstracts):91A.
21. Kerstjens HAM, Engel M, Dahl R, Paggiaro P, Beck E, Vandewalker M, et al. Tiotropium in asthma poorly controlled with standard combination therapy. New England Journal of Medicine 2012;367(13):1198-207.
22. Vandewalker ML, Engel M, Schmidt H, Siebold W, Moroni-Zentgraf P, Kerstjens HAM, et al. Efficacy of tiotropium in patients with asthma in relation to allergic status [Abstract]. The Journal of Allergy and Clinical Immunology 2013;131(2 Suppl 1):AB1.
23. Bateman ED, Kornmann O, Schmidt P, Pivovarova A, Engel M, Fabbri LM. Tiotropium is noninferior to salmeterol in maintaining improved lung function in B16-Arg/Arg patients with asthma. The Journal of Allergy and Clinical Immunology 2011;128(2):315-22.
24. NCT00350207. A 16-week randomised, placebo-controlled, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of tiotropium inhalation solution delivered by the Respimat inhaler (2 actuations of 2.5 mcg once daily) with that of salmeterol from the hydrofluoroalkane metered dose inhaler (2 actuations of 25 mcg twice daily) in moderate persistent asthma patients with the B16-Arg/Arg genotype. http://clinicaltrials.gov/show/NCT00350207 (accessed 19 January 2015).
25. NCT00557180. Obesity, Inflammation and Response to Therapy in Asthma - Ancillary to Asthma Clinical Research Network (ACRN) Trials. https://clinicaltrials.gov/ct2/show/NCT00557180 (accessed 19 January 2015).
26. NCT00706446. Genotype stratified treatment with anticholinergic vs. beta-agonist (long acting) and exacerbations (GABLE). http://clinicaltrials.gov/show/NCT00706446 (accessed 19 January 2015).
27. NCT01172808. A phase III randomised, double-blind, placebo-controlled, parallel-group trial to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 and 5 μg once daily) compared with placebo and salmeterol HFA MDI (50 μg twice daily) over 24 weeks in moderate persistent asthma. http://clinicaltrials.gov/show/NCT01172808 (accessed 19 January 2015).
28. NCT01172821. A Phase III randomised, double-blind, placebo-controlled, parallel-group trial to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 and 5 μg once daily) compared with placebo and salmeterol HFA MDI (50 μg Twice Daily) over 24 weeks in moderate persistent asthma. http://clinicaltrials.gov/show/NCT01172821 (accessed 19 January 2015).
29. NCT01290874. Blacks and Exacerbations on LABA vs. Tiotropium (BELT). http://clinicaltrials.gov/show/NCT01290874 (accessed 19 January 2015).
30. NCT01316380. A Phase III, randomised, double-blind, placebo-controlled, parallel-group trial to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 ug and 5 ug once daily) compared to placebo over 12 weeks in mild persistent asthma. http://clinicaltrials.gov/show/NCT01316380 (accessed 19 January 2015).
31. NCT01340209. A Phase III randomised, double-blind, placebo-controlled, parallel-group trial to evaluate safety and efficacy of tiotropium inhalation solution delivered via Respimat inhaler (2.5 and 5 μg Once Daily) compared with placebo over 52 weeks in patients with moderate to severe persistent asthma. http://clinicaltrials.gov/show/NCT01340209 (accessed 19 January 2015).
32. NCT01573624. A multi-center, randomized, double-blind, dose-ranging study to evaluate GSK573719 in combination with fluticasone furoate, fluticasone furoate alone, and an active control of fluticasone furoate/vilanterol combination in subjects with asthma. http://clinicaltrials.gov/show/NCT01573624 (accessed 19 January 2015).
33. NCT01641692. A multi-national, randomized, double-blind, placebo-controlled, 3-period crossover study with GSK 573719 as monotherapy in adult subjects with asthma. http://clinicaltrials.gov/show/NCT01641692 (accessed 19 January 2015).
34. NCT01696214. SAPS: smoking asthmatics pilot study. http://clinicaltrials.gov/show/NCT01696214 (accessed 19 January 2015).
35. NCT02127697. A randomized, double-blind, parallel group, 52-week study evaluating the efficacy, safety and tolerability of NVA237 in patients with poorly controlled asthma. http://clinicaltrials.gov/show/NCT02127697 (accessed 19 January 2015).
36. Paggiaro P, Engel M, Tudoric N, Forstner B, Radeczky E, Zubek V, et al. Phase III trial of tiotropium as add-on therapy to low-dose inhaled corticosteroids for patients with symptomatic mild persistent asthma: Design and planned analyses [Abstract]. European Respiratory Journal 2013;42(Suppl 57):877s [P4133].
37. Paggiaro P, Halpin DMG, Buhl R, Engel M, Zubek V, Blahova Z, et al. Tiotropium respimat add-on to inhaled corticosteroids improves lung function in patients with symptomatic mild asthma: Results from a phase III trial. The Journal of Allergy and Clinical Immunology 2014;133(2 Suppl):AB4.
38. Rajanandh MG, Nageswari AD, Ilango K. Assessment of various second-line medications in addition to inhaled corticosteroid in asthma patients: a randomized controlled trial. Clinical and Experimental Pharmacology and Physiology 2014;41(7):509-13.
39. Rajanandh MG, Nageswari AD, Ilango K. Pulmonary function assessment in mild to moderate persistent asthma patients receiving montelukast, doxofylline, and tiotropium with budesonide: a randomized controlled study. Clinical Therapeutics 2014;36(4):526-33.
40. Tashkin DP, Moroni-Zentgraf P, Engel M, Schmidt H, Kerstjens HAM. Once-daily tiotropium reduces risk of exacerbations and asthma worsening in patients with symptomatic asthma despite treatment with inhaled corticosteroids and long-acting beta2-agonists [Abstract]. Chest 2013;144(4 Meeting Abstracts):90A.
41. Vogelberg C, Engel M, Moroni-Zentgraf P, Leonaviciute-Klimantaviciene M, Sigmund R, Downie J, et al. Once-daily tiotropium in adolescents with symptomatic asthma despite inhaled corticosteroid treatment: a dose-ranging study [Abstract]. Clinical and Translational Allergy 2014;4(Suppl 1):O5.
42. Adams NP, Bestall JB, Malouf R, Lasserson TJ, Jones PW. Beclomethasone versus placebo for chronic asthma. Cochrane Database of Systematic Reviews 2005, Issue 1. [DOI: 10.1002/14651858.CD002738.pub2]
43. Adams NP, Bestall JC, Lasserson TJ, Jones P, Cates CJ. Fluticasone versus placebo for chronic asthma in adults and children. Cochrane Database of Systematic Reviews 2008, Issue 4. [DOI: 10.1002/14651858.CD003135.pub4]
44. Allison DE, Kew KM, Boyter AC. Long-acting muscarinic antagonists (LAMA) added to inhaled corticosteroids (ICS) versus the same dose of ICS for adults with asthma. Cochrane Database of Systematic Reviews 2014, Issue 11. [DOI: 10.1002/14651858.CD011397]
45. Anderson HR. Prevalence of asthma. British Medical Journal 2005;330:1037.
46. Bateman ED, Boushey HA, Bousquet J, Busse WW, Clark TJ, Pauwels RA, et al. Can guideline-defined asthma control be achieved? The gaining optimal asthma control study. American Journal of Respiratory and Critical Care Medicine 2004;170(8):836-44.
47. Befekadu E, Onofrei C, Colice GL. Tiotropium in asthma: a systematic review. Journal of Asthma and Allergy 2014;7:11-21.
48. Royal Pharmaceutical Society. British National Formulary (online). http://www.medicinescomplete.com. Royal Pharmaceutical Society, (accessed 27 August 2014).
49. Brozek J, Oxman A, Schünemann H. GradePro Version 3.2 for Windows. Hamilton (Ontario): McMaster University, 2014, 2008.
50. British Thoracic Society, Scottish Intercollegiate Guidelines Network. British guideline on the management of asthma. Thorax 2014;69(Suppl. 1):i1-i192.
51. Chauhan BF, Ducharme FM. Addition to inhaled corticosteroids of long-acting beta2-agonists versus anti-leukotrienes for chronic asthma. Cochrane Database of Systematic Reviews 2014, Issue 1. [DOI: 10.1002/14651858.CD003137.pub5]
52. Chinchilli VM. Allocation concealment used in our trial [personal communication]. Email to: D Evans. 16 January 2015.
53. Chong J, Karner C, Poole P. Tiotropium versus long-acting beta-agonists for stable chronic obstructive pulmonary disease. Cochrane Database of Systematic Reviews 2012, Issue 9. [DOI: 10.1002/14651858.CD009157.pub2]
54. The Alfred Hospital, Monash University, National ICT Australia and the University of London. Covidence. Melbourne: Alfred Health, 2013.
55. De Blic J, Delacourt C, Le Bourgeois M, Mahut B, Ostinelli J, Caswell C, et al. Efficacy of nebulized budesonide in treatment of severe infantile asthma: a double-blind study. The Journal of Allergy and Clinical Immunology 1996;98(1):14-20.
56. Ducharme FM, Ni Chroinin M, Greenstone I, Lasserson TJ. Addition of long-acting beta2-agonists to inhaled corticosteroids versus same dose inhaled corticosteroids for chronic asthma in adults and children. Cochrane Database of Systematic Reviews 2008, Issue 5. [DOI: 10.1002/14651858.CD005535.pub2]
57. Ducharme FM, Ni Choinin M, Greenstone I, Lasserson TJ. Addition of long-acting beta2-agonists to inhaled steroids versus higher dose inhaled steroids in adults and children with persistent asthma. Cochrane Database of Systematic Reviews 2010, Issue 4. [DOI: 10.1002/14651858.CD005533.pub2]
58. Elbourne DR, Altman DG, Higgins JPT, Curtin F, Worthington HV, Vail A. Meta-analyses involving cross-over trials: methodological issues. International Journal of Epidemiology 2002;31(1):140-9.
59. Electronic Medicines Compendium (eMC). License extension 19th September 2014: Spiriva Respimat 2.5 micrograms solution for inhalation. https://www.medicines.org.uk/emc/history/20134 (accessed 24 October 2014).
60. Global Initiative for Asthma. Global Strategy For Asthma Management And Prevention. http://www.ginasthma.org/documents/4 (accessed 22 August 2014).
61. International Union Against Tuberculosis and Lung Disease. The Global Asthma Report 2014. The Global Asthma Report 2014, http://www.globalasthmareport.org (accessed 28th August 2014).
62. Gosens R, Zaagsma J, Meurs H, Halayko AJ. Muscarinic receptor signaling in the pathophysiology of asthma and COPD. Respiratory Research 2006;7(1):73.
63. Haahtela T, Järvinen M, Kava T, Kiviranta K, Koskinen S, Lehtonen K, et al. Effects of reducing or discontinuing inhaled budesonide inpatients with mild asthma. New England Journal of Medicine 1994;331(11):700-5.
64. Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. www.cochrane-handbook.org.
65. Juniper EF, Kline PA, Vanzieleghem MA, Hargreave FE. Reduction of budesonide after a year of increased use: a randomized controlled trial to evaluate whether improvements in airway responsiveness and clinical asthma are maintained. The Journal of Allergy and Clinical Immunology 1991;87(2):483-9.
66. Juniper EF, Bousquet J, Abetz L, Bateman ED, GOAL Committee. Identifying 'well-controlled' and 'not well-controlled' asthma using the Asthma Control Questionnaire. Respiratory Medicine 2006;100(4):616-21.
67. Karner C, Chong J, Poole P. Tiotropium versus placebo for chronic obstructive pulmonary disease. Cochrane Database of Systematic Reviews 2014, Issue 7. [DOI: 10.1002/14651858.CD009285.pub3]
68. Kew KM, Evans DJW, Allison DE, Boyter AC. Long-acting muscarinic antagonists (LAMA) added to inhaled corticosteroids (ICS) versus addition of long-acting beta2-agonists (LABA) for adults with asthma. Cochrane Database of Systematic Reviews 2015, Issue 6. [DOI: 10.1002/14651858.CD011438.pub2]
69. Lipworth BJ. Emerging role of long acting muscarinic antagonists for asthma. British Journal of Clinical Pharmacology 2014;77(1):55-62.
70. Chandler J, Churchill R, Higgins J, LassersonT, Tovey D. Methodological Expectations for the conduct of Cochrane Intervention Review, version 2.3. http://editorial-unit.cochrane.org/mecir. (accessed 3rd Feb 2015).
71. Moulton BC, Fryer AD. Muscarinic receptor antagonists, from folklore to pharmacology; finding drugs that actually work in asthma and COPD. British Journal of Clinical Pharmacology 2011;163(1):44-52.
72. Ni H, Soe Z, Moe S. Aclidinium bromide for stable chronic obstructive pulmonary disease. Cochrane Database of Systematic Reviews 2014, Issue 9. [DOI: 10.1002/14651858.CD010509.pub2]
73. National Institute for Health and Care Excellence. NICE advice [KTT5] High-dose inhaled corticosteroids in asthma. http://www.nice.org.uk/Advice/ktt5 (accessed 29 August 2014).
74. Royal College of Physicians. Why Asthma Still Kills: The National Review of Asthma Deaths (NRAD) Confidential Enquiry Report. London: Royal College of Physicians, 2014.
75. Rashid Q, Klein R. Tiotropium in the treatment of patients with asthma. Southern Medical Journal 2014;107(5):330-7.
76. Reddel HK, Taylor DR, Bateman ED, Boulet LP, Boushey HA, Busse WW, et al. An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. Am J Respir Crit Care Med 2009;180(1):59-99.
77. The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). 5.3. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014.
78. Rodrigo GJ, Castro-Rodríguez JA. What is the role of tiotropium in asthma?: A systematic review with meta-analysis. Chest 2015;147(2):388-96.
79. Tee A, Koh MS, Gibson PG, Lasserson TJ, Wilson A, Irving LB. Long-acting beta2-agonists versus theophylline for maintenance treatment of asthma. Cochrane Database of Systematic Reviews 2007, Issue 3. [DOI: 10.1002/14651858.CD001281.pub2]
80. Verhamme KM, Afonso A, Romio S, Stricker BC, Brusselle GG, Sturkenboom MC. Use of tiotropium Respimat Soft Mist Inhaler versus HandiHaler and mortality in patient with COPD. European Respiratory Journal 2013;42(3):606-15.
81. Wise RA, Anzueto A, Cotton D, Dahl R, Devins T, Disse B, et al. Tiotropium Respimat Inhaler and the risk of death in COPD. New England Journal of Medicine 2013;369(16):1491-501.
82. Kew KM, Allison DE, Evans DJW, Boyter AC. Long-acting muscarinic antagonists (LAMA) added to inhaled corticosteroids (ICS) versus higher dose ICS for adults with asthma. Cochrane Database of Systematic Reviews 2014, Issue 12. [DOI: 10.1002/14651858.CD011437]