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ASTHMA MANAGEMENT AND TREATMENT

Treatment of Persistent Asthma With Symbicort® (Budesonide/Formoterol Inhalation Aerosol): An Inhaled Corticosteroid and Long-Acting β2-Adrenergic Agonist in One Pressurized Metered-Dose Inhaler

, M.D. & , M.D.
Pages 447-459 | Published online: 09 Jun 2010

References

  • National Asthma Education and Prevention Program. Expert panel report 3: guidelines for the diagnosis and management of asthma—full report. Bethesda, MD: National Institutes of Health, 2007. NIH Publication Number 08–4051.
  • SYMBICORT® (budesonide/formoterol inhalation aerosol) [prescribing information]. Wilmington, DE: AstraZeneca LP, 2009.
  • Lyseng-Williamson KA, Simpson D. Budesonide/formoterol pressurized metered-dose inhaler. Drugs 2008; 68:1855–1864.
  • Goldsmith DR, Keating GM. Budesonide/formoterol. A review of its use in asthma. Drugs 2004; 64:1597–1618.
  • Zetterström O, Buhl R, Mellem H, Perpiñá M, Hedman J, O'Neill S, Ekström T. Improved asthma control with budesonide/formoterol in a single inhaler, compared with budesonide alone. Eur Respir J 2001; 18:262–268.
  • Buhl R, Creemers JPHM, Vondra V, Martelli NA, Naya IP, Ekström T. Once-daily budesonide/formoterol in a single inhaler in adults with moderate persistent asthma. Respir Med 2003; 97:323–330.
  • Lalloo UG, Malolepszy J, Kozma D, Krofta K, Ankerst J, Johansen B, Thomson NC. Budesonide and formoterol in a single inhaler improves asthma control compared with increasing the dose of corticosteroid in adults with mild-to-moderate asthma. Chest 2003; 123:1480–1487.
  • Rosenhall L, Heinig JH, Lindqvist A, Leegaard J, Ståhl E, Bergqvist PBF. Budesonide/formoterol (Symbicort®) is well tolerated and effective in patients with moderate persistent asthma. Int J Clin Pract 2002; 56:427–433.
  • Rosenhall L, Elvstrand A, Tilling B, Vinge I, Jemsby P, Ståhl E, Jerre F, Bergqvist PB. One-year safety and efficacy of budesonide/formoterol in a single inhaler (Symbicort® Turbuhaler®) for the treatment of asthma. Respir Med 2003; 97:702–708.
  • Tal A, Simon G, Vermeulen JH, Petru V, Cobos N, Everard ML, de Boeck K. Budesonide/formoterol in a single inhaler versus inhaled corticosteroids alone in the treatment of asthma. Pediatr Pulmonol 2002; 34:342–350.
  • Morice AH, Peterson S, Beckman O, Osmanliev D. Therapeutic comparison of a new budesonide/formoterol pMDI with budesonide pMDI and budesonide/formoterol DPI in asthma. Int J Clin Pract 2007; 61:1874–1883.
  • Morice AH, Peterson S, Beckman O, Kukova Z. Efficacy and safety of a new pressurized metered-dose inhaler formulation of budesonide/formoterol in children with asthma: a superiority and therapeutic equivalence study. Pulm Pharmacol Ther 2008; 21:152–159.
  • Morice AH, Hochmuth L, Ekelund J, Thorén A, Puterman AS. Comparable long-term safety and efficacy of a novel budesonide/formoterol pressurized metered-dose inhaler versus budesonide/formoterol Turbuhaler in adolescents and adults with asthma. Pulm Pharmacol Ther 2008; 21:32–39.
  • Nelson HS, Weiss ST, Bleecker ER, Yancey SW, Dorinsky PM, the SMART Study Group. The Salmeterol Multicenter Asthma Research Trial: a comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol. Chest 2006; 129:15–26.
  • Malone R, LaForce C, Nimmagadda, Schoaf L, House K, Ellsworth A, Dorinsky P. The safety of twice-daily treatment with fluticasone propionate and salmeterol in pediatric patients with persistent asthma. Ann Allergy Asthma Immunol 2005; 95:66–71.
  • Bergmann K-C, Lindemann L, Braun R, Steinkamp G. Salmeterol/fluticasone propionate (50/250 μg) combination is superior to double dose fluticasone (500 μg) for the treatment of symptomatic moderate asthma. Swiss Med Wkly 2004; 134:50–58.
  • Pauwels RA, Löfdahl C-G, Postma DS, Tattersfield AE, O'Byrne P, Barnes PJ, Ullman A For the Formoterol and Corticosteroids Establishing Therapy (FACET) International Study Group. Effect of inhaled formoterol and budesonide on exacerbations of asthma. N Engl J Med 1997; 337:1405–1411.
  • Kavuru M, Melamed J, Gross G, Laforce C, House K, Prillaman B, Baitinger L, Woodring A, Shah T. Salmeterol and fluticasone propionate combined in a new powder inhalation device for the treatment of asthma: a randomized, double-blind, placebo-controlled trial. J Allergy Clin Immunol 2000; 105:1108–1116.
  • Sears MR, Ottosson A, Radner F, Suissa S. Long-acting β-agonists: a review of formoterol safety data from asthma clinical trials. Eur Respir J 2009; 33:21–32.
  • Wijesinghe M, Weatherall M, Perrin K, Harwood M, Beasley R. Risk of mortality associated with formoterol: a systematic review and meta-analysis. Eur Respir J 2009; 34:803–811.
  • Summary minutes of the Joint Pulmonary-Allergy Drugs Advisory Committee (PADAC), Drug Safety and Risk Management Advisory Committee (DSaRM), and Pediatric Advisory Committee (PAC). December 10–44, 2008. Available at: http://www.fda.gov/ohrms/dockets/ac/08/minutes/2008–4398m1-final.pdf . Accessed November 16, 2009.
  • Levenson M. Long-acting beta-agonists and adverse asthma events meta-analysis: statistical briefing package for joint meeting of the Pulmonary-Allergy Drugs Advisory Committee, Drug Safety and Risk Management Advisory Committee, and Pediatric Advisory Committee on December 10–11, 2008. Available at: http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008–4398b1–01-FDA.pdf . Accessed April 20, 2009.
  • Kramer JM. Balancing the benefits and risks of inhaled long-acting beta-agonists—the influence of values. N Engl J Med 2009; 360:1592–1595.
  • Nelson H, Bonuccelli C, Radner F, Ottosson A, Carroll KJ, Andersson TL, LaForce C. Safety of formoterol in asthma patients: combined analysis of data from double-blind, randomized controlled trials of patients with asthma. J Allergy Clin Immunol 2010;152:390–396.
  • Noonan M, Rosenwasser LJ, Martin P, O'Brien CD, O'Dowd L. Efficacy and safety of budesonide and formoterol in one pressurised metered-dose inhaler in adults and adolescents with moderate to severe asthma: a randomised clinical trial. Drugs 2006; 66:2235–2254.
  • Corren J, Korenblat PE, Miller CJ, O'Brien CD, Mezzanotte WS. Twelve-week, randomized, placebo-controlled, multicenter study of the efficacy and tolerability of budesonide and formoterol in one metered-dose inhaler compared with budesonide alone and formoterol alone in adolescents and adults with asthma. Clin Ther 2007; 29:823–843.
  • Peters SP, Prenner BM, Mezzanotte WS, Martin P, O'Brien CD. Long-term safety and asthma control with budesonide/formoterol versus budesonide pressurized metered-dose inhaler in asthma patients. Allergy Asthma Proc 2008; 29:499–516.
  • Murphy KR, Pearlman DS, Uryniak T, O'Brien CD, Mezzanotte WS. Efficacy of budesonide/formoterol pressurized metered-dose inhaler (BUD/FM pMDI) in children with asthma previously treated with inhaled corticosteroids (ICSs). Am J Respir Crit Care Med 2008; 177:A710.
  • Berger WE, Leflein JG, Uryniak T, O'Brien CD, O'Dowd L. The safety and clinical benefit of budesonide/formoterol pressurized metered-dose inhaler versus budesonide alone in children. Allergy Asthma Proc 2010; 31:26−39.
  • Busse WW, Shah SR, Sommerville L, Parasuraman B, Martin P, Goldman M. Comparison of adjustable- and fixed-dose budesonide/formoterol pressurized metered-dose inhaler and fixed-dose fluticasone propionate/salmeterol dry powder inhaler in asthma patients. J Allergy Clin Immunol 2008; 121:1407–1414.
  • Eid NS, Noonan MJ, Uryniak T, O'Brien CD. Efficacy of once-daily (qd) budesonide/formoterol pressurized metered-dose inhaler (BUD/FM pMDI) in children and adolescents with asthma previously stable on twice-daily (bid) BUD/FM pMDI. Am J Respir Crit Care Med 2008; 177:A710.
  • Kerwin EM, Oppenheimer JJ, LaForce C, Parasuraman B, Miller CJ, O'Dowd L, Goldman M. Efficacy and tolerability of once-daily budesonide/formoterol pressurized metered-dose inhaler in adults and adolescents with asthma previously stable with twice-daily budesonide/formoterol dosing. Ann Allergy Asthma Immunol 2009; 103:62–72.
  • Berger WE, Bleecker ER, O'Dowd L, Miller CJ, Mezzanotte WS. Efficacy and safety of budesonide/formoterol pressurized metered-dose inhaler: randomized controlled trial comparing once- and twice-daily dosing in patients with asthma. Allergy Asthma Proc 2010; 31:49–59.
  • Juniper EF, Buist AS, Cox FM, Ferrie PJ, King DR. Validation of a standardized version of the Asthma Quality of Life Questionnaire. Chest 1999; 115:1265–1270.
  • Mathias SD, Warren EH, Colwell HH, Sung JC. A new treatment satisfaction measure for asthmatics: a validation study. Qual Life Res 2000; 9:873–882.
  • Juniper EF, Guyatt GH, Willan A, Griffith LE. Determine a minimal important change in a disease-specific Quality of Life Questionnaire. J Clin Epidemiol 1994; 47:81–87.
  • Chervinsky P, Baker J, Bensch G, Parasuraman B, Boggs R, Martin P, O'Dowd L. Patient-reported outcomes in adults with moderate to severe asthma after use of budesonide and formoterol administered via one pressurized metered-dose inhaler. Ann Allergy Asthma Immunol 2008; 101:463–473.
  • Murphy K, Nelson H, Parasuraman B, Boggs R, Miller C, O'Dowd L. The effect of budesonide and formoterol in one pressurized metered-dose inhaler on patient-reported outcomes in adults with mild-to-moderate persistent asthma. Curr Med Res Opin 2008; 24:879–894.
  • Pearlman DS, Murphy KR, Uryniak T, O'Brien CD, Mezzanotte WS. Safety of budesonide/formoterol pressurized metered-dose inhaler (BUD/FM pMDI) in children with asthma previously treated with inhaled cortico-steroids (ICSs). Am J Respir Crit Care Med 2008; 177:A710.
  • Kaiser HB, Parasuraman B, Boggs R, Miller CJ, Leidy NK, O'Dowd L. Onset of effect of budesonide and formoterol administered via one pressurized metered-dose inhaler in adults and adolescents with asthma previously treated with inhaled corticosteroids. Ann Allergy Asthma Immunol 2008; 101:295–303.
  • Leidy NK, Mathias SD, Parasuraman BM, Patrick, DL. Development and validation of an onset of effect questionnaire for patients with asthma. Allergy Asthma Proc 2008; 29:590–599.
  • Hauber AB, Mohamed AF, Johnson FR, Meddis D, Wagner S, O'Dowd L. Quantifying asthma patient preferences for onset of effect of combination inhaled corticosteroids and long-acting beta2-agonist maintenance medications. Allergy Asthma Proc 2009; 30:139–147.
  • Harding G, Kline Leidy N, Meddis D, Kleinman L, Wagner S, O'Brien C. Interpreting clinical trial results of patient-perceived onset of effect in asthma: methods and results of a Delphi panel. Curr Med Res Opin 2009; 1563–1571.
  • Murphy KR, Bender BG. Treatment of moderate to severe asthma: patient perspectives on combination inhaler therapy and implications for adherence. J Asthma Allergy 2009; 12:63–72.
  • Dolovich MB, Ahrens RC, Hess DR, Anderson P, Dhand R, Rau JL, Smaldone GC, Guyatt G; American College of Chest Physicians; American College of Asthma, Allergy, and Immunology. Device selection and outcomes of aerosol therapy: evidence-based guidelines. Chest 2005; 127:335–371.
  • Chambers FE, Brown S, Ludzik AJ. Comparative in vitro performance of valved holding chambers with a budesonide/formoterol pressurized metered-dose inhaler. Allergy Asthma Proc 2009; 30:424–432.
  • Aalbers R, Backer V, Kava TTK, Omenaas ER, Sandström T, Jorup C, Welte T. Adjustable maintenance dosing with budesonide/formoterol compared with fixed-dose salmeterol/fluticasone in moderate to severe asthma. Curr Med Res Opin 2004; 20:225–240.
  • Kuna P, Peters MJ, Manjra AI, Jorup C, Naya IP, Martínez-Jimenez NE, Buhl R. Effect of budesonide/formoterol maintenance and reliever therapy on asthma exacerbations. Int J Clin Pract 2007; 61:725–736.
  • Lasserson TJ, Cates CJ, Ferrara G, Casali L. Combination fluticasone and salmeterol versus fixed dose combination budesonide and formoterol for chronic asthma in adults and children. Cochrane Database Syst Rev 2008; (1):CD004106.
  • O'Connor RD, Patrick D, Parasuraman B, Martin P, Goldman M. Comparison of patient-reported outcomes during treatment with adjustable- and fixed-dose budesonide/formoterol pMDI versus fixed-dose flutica-sone propionate/salmeterol DPI in patients with asthma. J Asthma 2010; 47:217–233.
  • Martin ML, Bushnell DM, Parasuraman B, Meltzer EO, Patrick DL. Validation of the Asthma Treatment Satisfaction Measure (ATSM). Am J Respir Crit Care Med 2008; 177:A573.
  • Patrick DL, Martin ML, Bushnell DM, Meltzer EO, Parasuraman B. Development of a treatment satisfaction measure for asthma patients: The Asthma Treatment Satisfaction Measure (ATSM). Am J Respir Crit Care Med 2008; 177:A573.
  • Hampel FC, Martin P, Mezzanotte WS. Early bronchodilatory effects of budesonide/formoterol pMDI compared with fluticasone/salmeterol DPI and albuterol pMDI: 2 randomized controlled trials in adults with persistent asthma previously treated with inhaled corticosteroids. J Asthma 2008; 45:265–272.
  • McCormack PL, Lyseng-Williamson KA. Budesonide/formoterol: a review of its use as maintenance and reliever inhalation therapy in asthma. Drugs 2007; 16:2407–2431.
  • O'Byrne PM, Bisgaard H, Godard PP, Pistolesi M, Palmqvist M, Zhu Y, Ekström T, Bateman ED. Budesonide/formoterol combination therapy as both maintenance and reliever medication in asthma. Am J Respir Crit Care Med 2005; 171:129–136.
  • Rabe KF, Atienza T, Magyar P, Larsson P, Jorup C, Lalloo MG. Effect of budesonide in combination with formoterol for reliever therapy in asthma exacerbations: a randomized controlled, double-blind study. Lancet 2006; 368:744–753.
  • Israel E, Chinchilli VM, Ford JG, Boushey HA, Cherniack R, Craig TJ, et al; National Heart, Lung, and Blood Institute's Asthma Clinical Research Network. Use of regularly scheduled albuterol treatment in asthma: genotype-stratified, randomised, placebo-controlled cross-over trial. Lancet 2004; 364:1505–1512.
  • Israel E, Drazen JM, Liggett SB, Boushey HA, Cherniack RM, Chinchilli VM, et al. The effect of polymorphisms of the beta(2)-adrenergic receptor on the response to regular use of albuterol in asthma. Am J Respir Crit Care Med 2000; 162:75–80.
  • Taylor DR, Drazen JM, Herbison GP, Yandava CN, Hancox RJ, Town GI. Asthma exacerbations during long term β agonist use: influence of β2 adrenoceptor polymorphism. Thorax 2000; 55:762–767.
  • Bleecker ER, Yancey SW, Baitinger LA, Edwards LD, Klotsman M, Anderson WH, Dorinsky PM. Salmeterol response is not affected by β2-adrenergic receptor genotype in subjects with persistent asthma. J Allergy Clin Immunol 2006; 118:809–816.
  • Bleecker ER, Postma DS, Lawrance RM, Meyers DA, Ambrose HJ, Goldman M. Effect of ADRB2 polymorphisms on response to longacting β2-agonist therapy: a pharmacogenetic analysis of two randomised studies. Lancet 2007; 370:2118–2125.
  • Wechsler ME, Lehman E, Lazarus SC, Lemanske RF Jr, Boushey HA, Deykin A; National Heart, Lung, and Blood Institute's Asthma Clinical Research Network. β-Adrenergic receptor polymorphisms and response to salmeterol. Am J Respir Crit Care Med 2006; 173:519–526.
  • Pearlman DS, White MV, Lieberman AK, Pepsin PJ, Kalberg C, Emmett A, Bowers B, Rickard KA, Dorinsky P. Fluticasone propionate/salmeterol combination compared with montelukast for the treatment of persistent asthma. Ann Allergy Asthma Immunol 2002; l88:227–235.
  • Calhoun W, Nelson HS, Nathan RA, Pepsin PJ, Kalberg C, Emmett A, Rickard KA, Dorinsky P. Comparison of fluticasone propionate-salmeterol combination therapy and montelukast in subjects who are symptomatic on short-acting β2-agonist alone. Am J Respir Crit Care Med 2001; 164:759–763.
  • Yancey SW, Klotsman M, Ortega HG, Edwards LD, Anderson WH. Acute and chronic lung function responses to salmeterol and salmeterol plus fluticasone propionate in relation to Arg16Gly β2-adrenergic polymorphism. Curr Med Res Opin 2009; 25:1011–1016.
  • Bleecker ER, Nelson HS, Kraft M. β2-Receptor polymorphisms in patients receiving salmeterol with or without fluticasone propionate. Am J Respir Crit Care Med 2010; 181:676–687.
  • Lawrance R, Ambrose H, Goldman M. Effect of Gly16Arg β2-adrenergic receptor variation on the long-term safety of formoterol (FM) in combination with budesonide (BUD) and of BUD alone, delivered via one pressurized metered-dose inhaler (pMDI) in patients with moderate to severe asthma. Am J Respir Crit Care Med 2007; 175:A59.
  • Ambrose H, Lawrance R, Goldman M. Beta-adrenergic receptor Gly16Arg variation: effect on response to budesonide/formoterol or budesonide (post-formoterol) in asthma patients. Chest 2007; 132:436S.
  • Ferdinands JM, Mannino DM, Gwinn ML, Bray MS. ADRB2 Arg16Gly polymorphism, lung function, and mortality: results from the atherosclerosis risk in communities study. PLoS One 2007; 2:e289. Published online doi:10.1371/journal.pone.0000289.
  • Bleecker ER, Lawrance RM, Ambrose HJ, Goldman M. Adrenergic receptor gene polymorphisms: is Arg/Arg genotype associated with serious adverse events during treatment with budesonide and formoterol in one pressurized metered-dose inhaler (BUD/FM pMDI) within racial groups? Am J Respir Crit Care Med 2008; 177:A775.

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