Abstract
Background and Objective: Inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) combinations are the preferred maintenance therapy for adult asthma patients uncontrolled by ICS alone. Supporting data are largely from mixed populations of adolescents and adults, although ICS/LABA combinations are not approved for adolescents in all countries. This analysis evaluates overall asthma control in asthma patients aged ≥16 years receiving ICS/LABA combinations.
Methods: This was a post hoc analysis of asthma patients aged ≥16 years in a randomized, double-blind/open-label extension, parallel-group study. Patients received fixed maintenance-dose budesonide/formoterol (Symbicort® Turbuhaler®), fixed maintenance-dose salmeterol/fluticasone propionate (Seretide/Advair/Adoair™ Diskus™) or adjustable maintenance-dose budesonide/formoterol. Patients used terbutaline or salbutamol for as-needed reliever medication. The primary efficacy variable was the odds of having a well controlled asthma week during the randomized treatment period.
Results: ICS/LABA regimens were well tolerated and efficacious, and the odds for achieving a well controlled asthma week did not differ between groups in this sub-analysis. The number of exacerbations was similar between fixed-dose regimens; however, there were trends toward fewer exacerbations requiring hospitalization/emergency room treatment in the fixed- and adjustable maintenance-dose budesonide/formoterol groups (three and two events, respectively) than in the fixed-dose salmeterol/fluticasone propionate group (eight events). Improvements in forced expiratory volume in 1 second (FEV1) were small but significantly greater with fixed-dose budesonide/formoterol versus fixed-dose salmeterol/fluticasone propionate.
Conclusions: This post hoc analysis supports the use of ICS/LABA combinations in adults aged ≥16 years.
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Notes
Symbicort® and Turbuhaler® are trademarks owned by AstraZeneca. The dry powder formulation Turbuhaler® is not currently approved in the US.
References
Partridge MR. Asthma: 1987–2007. What have we achieved and what are the persisting challenges? Prim Care Respir J 2007; 16(3): 145–8
Desfougeres J-L, Sohier B, Freedman D, et al. Has asthma control improved since AIRE? Results of a survey in 5 European countries [abstract]. Eur Respir J 2007; 30: 249s
Price D, Horne R, Ryan D, et al. ABS74: Large variations in asthma control between UK general practices participating in the asthma control, concordance and tolerance (ACCT) Initiative [abstract]. Prim Care Respir J 2006; 15: 206
Sovani MP, Whale CI, Oborne J, et al. Poor adherence with inhaled corticosteroids for asthma: can using a single inhaler containing budesonide and formoterol help? Br J Gen Pract 2008; 58(546): 37–43
Partridge MR, Van der Molen T, Myrseth SE, et al. Attitudes and actions of asthma patients on regular maintenance therapy: the INSPIRE study. BMC Pulm Med 2006; 6: 13
Rabe KF, Vermeire PA, Soriano JB, et al. Clinical management of asthma in 1999: the Asthma Insights and Reality in Europe (AIRE) study. Eur Respir J 2000; 16(5): 802–7
Haughney J, Barnes G, Partridge M, et al. The Living & Breathing Study: a study of patients views of asthma and its treatment. Prim Care Respir J 2004; 13(1): 28–35
FitzGerald JM, Boulet LP, McIvor RA, et al. Asthma control in Canada remains suboptimal: the Reality of Asthma Control (TRAC) study. Can Respir J 2006; 13(5): 253–9
Anderson HR, Ayres JG, Sturdy PM, et al. Bronchodilator treatment and deaths from asthma: case-control study. BMJ 2005; 330(7483): 117 doi:10.1136/bmj.38316.729907.8F (published 23 Dec 2004)
Spitzer WO, Suissa S, Ernst P, et al. The use of beta-agonists and the risk of death and near death from asthma. N Engl J Med 1992; 326(8): 501–6
Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention: NHLBI/WHO workshop report. Bethesda (MD): National Institutes of Health, National Heart, Lung and Blood Institute. Updated 2009 [online]. Available from URL: http://www.ginasthma.com. 2010 [Accessed 2010 Mar 1]
Pauwels RA, Lofdahl CG, Postma DS, et al. Effect of inhaled formoterol and budesonide on exacerbations of asthma. Formoterol and Corticosteroids Establishing Therapy (FACET) International Study Group. N Engl J Med 1997; 337(20): 1405–11
Ind PW, Dal Negro R, Colman NC, et al. Addition of salmeterol to fluticasone propionate treatment in moderate-to-severe asthma. Respir Med 2003; 97(5): 555–62
Greening AP, Ind PW, Northfield M, et al. Added salmeterol versus higher-dose corticosteroid in asthma patients with symptoms on existing inhaled corticosteroid. Allen & Hanburys Limited UK Study Group. Lancet 1994; 344(8917): 219–24
O’Byrne PM, Barnes PJ, Rodriguez-Roisin R, et al. Low dose inhaled budesonide and formoterol in mild persistent asthma: the OPTIMA randomized trial. Am J Respir Crit Care Med 2001; 164 (8 Pt 1): 1392–7
Bateman ED, Boushey HA, Bousquet J, et al. Can guideline-defined asthma control be achieved? The Gaining Optimal Asthma ControL study. Am J Respir Crit Care Med 2004; 170(8): 836–44
Shepherd J, Rogers G, Anderson R, et al. Systematic review and economic analysis of the comparative effectiveness of different inhaled corticosteroids and their usage with long-acting beta2 agonists for the treatment of chronic asthma in adults and children aged 12 years and over. Health Technol Assess 2008; 12(19): 1–360
Aalbers R, Backer V, Kava TT, et al. Adjustable maintenance dosing with budesonide/formoterol compared with fixed-dose salmeterol/fluticasone in moderate to severe asthma. Curr Med Res Opin 2004; 20(2): 225–40
Rabe KF, Pizzichini E, Stallberg B, et al. Budesonide/formoterol in a single inhaler for maintenance and relief in mild-to-moderate asthma: a randomized, double-blind trial. Chest 2006; 129(2): 246–56
Scicchitano R, Aalbers R, Ukena D, et al. Efficacy and safety of budesonide/formoterol single inhaler therapy versus a higher dose of budesonide in moderate to severe asthma. Curr Med Res Opin 2004; 20(9): 1403–18
21. O’Byrne PM, Bisgaard H, Godard PP, et al. Budesonide/formoterol combination therapy as both maintenance and reliever medication in asthma. Am J Respir Crit Care Med 2005; 171(2): 129–36
Kuna P, Peters MJ, Manjra AI, et al. Effect of budesonide/formoterol maintenance and reliever therapy on asthma exacerbations. Int J Clin Pract 2007; 61(5): 725–36
Rabe KF, Atienza T, Magyar P, et al. Effect of budesonide in combination with formoterol for reliever therapy in asthma exacerbations: a randomised controlled, double-blind study. Lancet 2006; 368(9537): 744–53
Vogelmeier C, D’Urzo A, Pauwels R, et al. Budesonide/formoterol maintenance and reliever therapy: an effective asthma treatment option? Eur Respir J 2005; 26(5): 819–28
Bousquet J, Boulet LP, Peters MJ, et al. Budesonide/formoterol for maintenance and relief in uncontrolled asthma vs. high-dose salmeterol/fluticasone. Respir Med 2007; 101(12): 2437–46
American Thoracic Society. Standards for the diagnosis and care of patients with chronic obstructive pulmonary disease (COPD) and asthma. Am Rev Respir Dis 1987; 136: 225–44
NAEPP (National Asthma Education and Prevention Program). Expert Panel Report 3: Guidelines for the diagnosis and management of asthma: 2007 [online]. Available from URL: http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.htm [Accessed 2010 May 1]
Taylor DR, Bateman ED, Boulet LP, et al. A new perspective on concepts of asthma severity and control. Eur Respir J 2008; 32(3): 545–54
Reddel HK, Taylor DR, Bateman ED, 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
Gibson PG, Powell H, Ducharme FM. Differential effects of maintenance long-acting beta-agonist and inhaled corticosteroid on asthma control and asthma exacerbations. J Allergy Clin Immunol 2007; 119(2): 344–50
Barnes NC. The properties of inhaled corticosteroids: similarities and differences. Prim Care Respir J 2007; 16(3): 149–54
Walters EH, Gibson PG, Lasserson TJ, et al. Long-acting beta2-agonists for chronic asthma in adults and children where background therapy contains varied or no inhaled corticosteroid. Cochrane Database Syst Rev 2007; (1): CD001385
Boonsawat W, Charoenratanakul S, Pothirat C, et al. Formoterol (OXIS) Turbuhaler as a rescue therapy compared with salbutamol pMDI plus spacer in patients with acute severe asthma. Respir Med 2003; 97(9): 1067–74
Cheung D, van Klink HC, Aalbers R. Improved lung function and symptom control with formoterol on demand in asthma. Eur Respir J 2006; 27(3): 504–10
van der Woude HJ, Boorsma M, Bergqvist PB, et al. Budesonide/formoterol in a single inhaler rapidly relieves methacholine-induced moderate-to-severe bronchoconstriction. Pulm Pharmacol Ther 2004; 17: 89–95
Palmqvist M, Arvidsson P, Beckman O, et al. Onset of bronchodilation of budesonide/formoterol vs. salmeterol/fluticasone in single inhalers. Pulm Pharmacol Ther 2001; 14: 29–34
Palmqvist M, Ibsen T, Mellen A, et al. Comparison of the relative efficacy of formoterol and salmeterol in asthmatic patients. Am J Respir Crit Care Med 1999; 160(1): 244–9
van Veen A, Weller FR, Wierenga EA, et al. A comparison of salmeterol and formoterol in attenuating airway responses to short-acting beta2-agonists. Pulm Pharmacol Ther 2003; 16(3): 153–61
Molimard M, Gros VL, Robinson P, et al. Prevalence and associated factors of oropharyngeal side effects in users of inhaled corticosteroids in a real-life setting. J Aerosol Med Pulm Drug Deliv 2010; 23(2): 91–5
Borgstrom L, Asking L, Thorsson L. Idealhalers or realhalers? A comparison of Diskus and Turbuhaler. Int J Clin Pract 2005; 59(12): 1488–95
Acknowledgements
The author thanks Dr Jonathan Brennan from MediTech Media Ltd, who provided medical writing support funded by AstraZeneca, and Dr Ollie Östlund, AstraZeneca, who provided statistical input/analysis. The author has no conflicts of interest that are directly relevant to the content of this study.
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Aalbers, R. Fixed or Adjustable Maintenance-Dose Budesonide/Formoterol Compared with Fixed Maintenance-Dose Salmeterol/Fluticasone Propionate in Asthma Patients Aged ≥16 Years. Clin. Drug Investig. 30, 439–451 (2010). https://doi.org/10.2165/11533420-000000000-00000
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DOI: https://doi.org/10.2165/11533420-000000000-00000