Combination Therapy: Appropriate for Everyone?

References

• Expert Panel Report 2: Guidelines for the Diagnosis and Management of Asthma. National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD 1997
   Google Scholar
• Nelson HS. Advair: combination treatment with fluticasone propionate/salmeterol in the treatment of asthma. J Allergy Clin Immunol 2001; 107(2)398–416
   PubMedGoogle Scholar
• Advair Diskus [monograph]. GlaxoSmithKline, Research Park, NC 2000
   Google Scholar
• Gross G, Thompson PJ, Chervinsky P, Vanden Burgt J. Hydrofluoroalkane-134a beclomethasone dipropionate, 400 µg, is as effective as chlorofluorocarbon beclomethasone dipropionate, 800 µg, for the treatment of moderate asthma. Chest 1999; 115(2)343–351
   PubMed Web of Science ®Google Scholar
• Corren J, Nelson H, Greos L, Bensch G, Goldstein M, Wu J, Wang S, Newman K. Effective control of asthma with hydrofluoroalkane flunisolide delivered as an extra fine aerosol in asthma patients. Ann Allergy Asthma Immunol 2001; 87: 405–411
   PubMed Web of Science ®Google Scholar
• Lipworth BJ. Systemic adverse effects of inhaled corticosteroid therapy: a systematic review and meta-analysis. Arch Intern Med 1999; 159(9)941–955
   PubMed Web of Science ®Google Scholar
• Lipworth BJ, Jackson CM. Safety of inhaled and intranasal corticosteroids: lessons for the new millennium. Drug Saf 2000; 23(1)11–33
   PubMed Web of Science ®Google Scholar
• Davies RJ, Stampone P, O'Connor BJ. Hydrofluoroalkane-134a beclomethasone dipropionate extrafine aerosol provides equivalent asthma control to chlorofluorocarbon beclomethasone dipropionate at approximately half the total daily dose. Respir Med 1998; 92(suppl A)23–31
   PubMed Web of Science ®Google Scholar
• Lal S, Dorow PD, Venho KK, Chatterjee SS. Nedocromil sodium is more effective than cromolyn sodium for the treatment of chronic reversible obstructive airway disease. Chest 1993; 104(2)438–447
   PubMedGoogle Scholar
• O'Hickey SP, Rees PJ. High-dose nedocromil sodium as an addition to inhaled corticosteroids in the treatment of asthma. Respir Med 1994; 88(7)499–502
   PubMedGoogle Scholar
• Svendsen UG, Jorgensen H. Inhaled nedocromil sodium as additional treatment to high dose inhaled corticosteroids in the management of bronchial asthma. Eur Respir J 1991; 4(8)992–999
   PubMedGoogle Scholar
• Childhood Asthma Management Program Research Group. Long-term effects of budesonide or nedocromil in children with asthma. N Engl J Med 2000; 343(15)1054–1063
   PubMed Web of Science ®Google Scholar
• Ukena D, Harnest U, Sakalauskas R, Magyar P, Vetter N, Steffen H, Leichtl S, Rathgeb F, Keller A, Steinijans VW. Comparison of addition of theophylline to inhaled steroid with doubling of the dose of inhaled steroid in asthma. Eur Respir J 1997; 10(12)2754–2760
   PubMed Web of Science ®Google Scholar
• Evans DJ, Taylor DA, Zetterstrom O, Chung KF, O'Connor BJ, Barnes PJ. A comparison of low-dose inhaled budesonide plus theophylline and high-dose inhaled budesonide for moderate asthma. N Engl J Med 1997; 337(20)1412–1418
   PubMed Web of Science ®Google Scholar
• Singulair [package insert]. Merck & Co., Inc., Whitehouse Station, NJ 2001
   Google Scholar
• Virchow JC., Jr, Prasse A, Naya I, Summerton L, Harris A, Zafirlucast Study group. Zafirlucast improves asthma control in patients receiving high-dose inhaled corticosteroids. Am J Respir Crit Care Med 2000; 162: 578–585
   PubMed Web of Science ®Google Scholar
• Laviolette M, Malmstrom K, Lu S, Chervinsky P, Pujet JC, Peszek I, Zhang J, Reiss TF. Montelukast added to inhaled beclomethasone in treatment of asthma. Montelukast/beclomethasone additivity group. Am J Respir Crit Care Med 1999; 160(6)1862–1868
   PubMed Web of Science ®Google Scholar
• Lofdahl CG, Reiss TF, Leff JA, Israel E, Noonan MJ, Finn AF, Seidenberg BC, Capizzi T, Kundu S, Godard P. Randomised, Placebo controlled trial of effect of a leukotriene receptor antagonist, montelukast, on tapering inhaled corticosteroids in asthmatic patients. BMJ 1999; 319(7202)87–90
   PubMed Web of Science ®Google Scholar
• Turner-Warwick M. Epidemiology of nocturnal asthma. Am J Med 1988; 85(1B)6–8
   PubMed Web of Science ®Google Scholar
• Walters EH, Bjermer L, Faurschou P, Sandstrom T. The anti-inflammatory profile of inhaled corticosteroids combined with salmeterol in asthmatic patients. Respir Med 2000; 94(suppl F)S26–S31
   PubMed Web of Science ®Google Scholar
• Donohue JF, Ohar JA. New combination therapies for asthma. Curr Opin Pulm Med 2001; 7(2)62–68
   PubMedGoogle Scholar
• Holimon TD, Chafin CC, Self TH. Nocturnal asthma uncontrolled by inhaled corticosteroids: theophylline or long-acting beta2 agonists?. Drugs 2001; 61(3)391–418
   PubMedGoogle Scholar
• Wallaert B, Brun P, Ostinelli J, Murciano D, Champel F, Blaive B, Montane F, Godard P. A comparison of two long-acting beta-agonists, oral bambuterol and inhaled salmeterol, in the treatment of moderate to severe asthmatic patients with nocturnal symptoms. The French bambuterol study group. Respir Med 1999; 93(1)33–38
   PubMedGoogle Scholar
• Wiegand L, Mende CN, Zaidel G, Zwillich CW, Petrocella VJ, Yancey SW, Rickard KA. Salmeterol vs. theophylline: sleep and efficacy outcomes in patients with nocturnal asthma. Chest 1999; 115(6)1525–1532
   PubMedGoogle Scholar
• Lockey RF, DuBuske LM, Friedman B, Petrocella V, Cox F, Rickard K. Nocturnal asthma: effect of salmeterol on quality of life and clinical outcomes. Chest 1999; 115(3)666–673
   PubMedGoogle Scholar
• Woolcock A, Lundback B, Ringdal N, Jacques LA. Comparison of addition of salmeterol to inhaled steroids with doubling of the dose of inhaled steroids. Am J Respir Crit Care Med 1996; 153(5)1481–1488
   PubMed Web of Science ®Google Scholar
• Busse W, Nelson H, Wolfe J, Kalberg C, Yancey SW, Rickard KA. Comparison of inhaled salmeterol and oral zafirlukast in patients with asthma. J Allergy Clin Immunol 1999; 103(6)1075–1080
   PubMedGoogle Scholar
• Edelman JM, Turpin JA, Bronsky EA, Grossman J, Kemp JP, Ghannam AF, DeLucca PT, Gormley GJ, Pearlman DS. Oral montelukast compared with inhaled salmeterol to prevent exercise-induced bronchoconstriction. A randomized, double-blind trial. Exercise study group. Ann Intern Med 2000; 132(2)97–104
   PubMedGoogle Scholar
• Volovitz B, Tabachnik E, Nussinovitch M, Shtaif B, Blau H, Gil-Ad I, Weizman A, Varsano I. Montelukast, a leukotriene receptor antagonist, reduces the concentration of leukotrienes in the respiratory tract of children with persistent asthma. J Allergy Clin Immunol 1999; 104(6)1162–1167
   PubMedGoogle Scholar
• Bratton DL, Lanz MJ, Miyazawa N, White CW, Silkoff PE. Exhaled nitric oxide before and after montelukast sodium therapy in school-age children with chronic asthma: a preliminary study. Pediatr Pulmonol 1999; 28(6)402–407
   PubMedGoogle Scholar
• Bisgaard H, Loland L, Oj JA. NO in exhaled air of asthmatic children is reduced by the leukotriene receptor antagonist montelukast. Am J Respir Crit Care Med 1999; 160(4)1227–1231
   PubMedGoogle Scholar
• Roberts JA, Bradding P, Britten KM, Walls AF, Wilson S, Gratziou C, Holgate ST, Howarth PH. The long-acting beta2-agonist salmeterol xinafoate: effects on airway inflammation in asthma. Eur Respir J 1999; 14(2)275–282
   PubMed Web of Science ®Google Scholar
• Calhoun WJ, Hinton KL, Kratzenberg JJ. The effect of salmeterol on markers of airway inflammation following segmental allergen challenge. Am J Respir Crit Care Med 2001; 163(4)881–886
   PubMedGoogle Scholar
• McIvor RA, Pizzichini E, Turner MO, Hussack P, Hargreave FE, Sears MR. Potential masking effects of salmeterol on airway inflammation in asthma. Am J Respir Crit Care Med 1998; 158(3)924–930
   PubMed Web of Science ®Google Scholar
• Bjermer L, Bisgaard H, Bousquet J, Fabbri LM, Greening A, Haahtela T, Holgate ST, Picado C, Leff JA. Montelukast or salmeterol combined with an inhaled steroid in adult asthma: design and rationale of a randomized, double-blind comparative study (the IMPACT investigation of montelukast as a partner agent for complementary therapy trial). Respir Med 2000; 94(6)612–621
   PubMedGoogle Scholar
• Barnes PJ. Scientific rationale for inhaled combination therapy with long-acting beta2-agonists and corticosteroids. Eur Respir J 2002; 19(1)182–191
   PubMed Web of Science ®Google Scholar
• Chung KF. The complementary role of glucocorticosteroids and long-acting beta-adrenergic agonists. Allergy 1998; 53(suppl)7–13
   PubMedGoogle Scholar
• Collins S, Caron MG, Lefkowitz RJ. Beta-adrenergic receptors in hamster smooth muscle cells are transcriptionally regulated by glucocorticoids. J Biol Chem 1988; 263(19)9067–9070
   PubMedGoogle Scholar
• Hadcock JR, Malbon CC. Regulation of beta-adrenergic receptors by “permissive” hormones: glucocorticoids increase steady-state levels of receptor mRNA. Proc Natl Acad Sci USA 1988; 85(22)8415–8419
   PubMedGoogle Scholar
• Eickelberg O, Roth M, Lorx R, Bruce V, Rudiger J, Johnson M, Block LH. Ligand-independent activation of the glucocorticoid receptor by beta2-adrenergic receptor agonists in primary human lung fibroblasts and vascular smooth muscle cells. J Biol Chem 1999; 274(2)1005–1010
   PubMed Web of Science ®Google Scholar
• Shrewsbury S, Pyke S, Britton M. Meta-analysis of increased dose of inhaled steroid or addition of salmeterol in symptomatic asthma (MIASMA). BMJ 2000; 320(7246)1368–1373
   PubMed Web of Science ®Google Scholar
• Hoshino M, Nakamura Y, Sim JJ, Yamashiro Y, Uchida K, Hosaka K, Isogai S. Inhaled corticosteroid reduced lamina reticularis of the basement membrane by modulation of insulin-like growth factor (IGF)-I expression in bronchial asthma. Clin Exp Allergy 1998; 28(5)568–577
   PubMedGoogle Scholar
• Newnham DM, Grove A, McDevitt DG, Lipworth BJ. Subsensitivity of bronchodilator and systemic beta 2 adrenoceptor responses after regular twice daily treatment with eformoterol dry powder in asthmatic patients. Thorax 1995; 50(5)497–504
   PubMedGoogle Scholar
• Nelson HS, Raine D., Jr, Doner HC, Posey WC. Subsensitivity to the bronchodilator action of albuterol produced by chronic administration. Am Rev Respir Dis 1977; 116(5)871–878
   PubMedGoogle Scholar
• Galant SP, Duriseti L, Underwood S, Insel PA. Decreased beta-adrenergic receptors on polymorphonuclear leukocytes after adrenergic therapy. N Engl J Med 1978; 299(17)933–936
   PubMedGoogle Scholar
• Grove A, Lipworth BJ. Bronchodilator subsensitivity to salbutamol after twice daily salmeterol in asthmatic patients. Lancet 1995; 346(8969)201–206
   PubMed Web of Science ®Google Scholar
• Fuglsang G, Vikre-Jorgensen J, Agertoft L, Pedersen S. Effect of salmeterol treatment on nitric oxide level in exhaled air and dose-response to terbutaline in children with mild asthma. Pediatr Pulmonol 1998; 25(5)314–321
   PubMedGoogle Scholar
• Booth H, Bish R, Walters J, Whitehead F, Walters EH. Salmeterol tachyphylaxis in steroid treated asthmatic subjects. Thorax 1996; 51(11)1100–1104
   PubMed Web of Science ®Google Scholar
• Villaran C, O'Neill SJ, Helbling A, van Noord JA, Lee TH, Chuchalin AG, Langley SJ, Gunawardena KA, Suskovic S, Laurenzi M, Jasan J, Menten J, Leff JA. Montelukast versus salmeterol in patients with asthma and exercise-induced bronchoconstriction. Montelukast/salmeterol exercise study group. J Allergy Clin Immunol 1999; 104(3 Pt 1)547–553
   PubMedGoogle Scholar
• Tan KS, Grove A, McLean A, Gnosspelius Y, Hall IP, Lipworth BJ. Systemic corticosteriod rapidly reverses bronchodilator subsensitivity induced by formoterol in asthmatic patients. Am J Respir Crit Care Med 1997; 156(1)28–35
   PubMedGoogle Scholar
• Aziz I, Lipworth BJ. A bolus of inhaled budesonide rapidly reverses airway subsensitivity and beta2-adrenoceptor down-regulation after regular inhaled formoterol. Chest 1999; 115(3)623–628
   PubMedGoogle Scholar
• Kalra S, Swystun VA, Bhagat R, Cockcroft DW. Inhaled corticosteroids do not prevent the development of tolerance to the bronchoprotective effect of salmeterol. Chest 1996; 109(4)953–956
   PubMed Web of Science ®Google Scholar
• Yates DH, Kharitonov SA, Barnes PJ. An inhaled glucocorticoid does not prevent tolerance to the bronchoprotective effect of a long-acting inhaled beta 2-agonist. Am J Respir Crit Care Med 1996; 154(6 Pt 1)1603–1607
   PubMedGoogle Scholar
• Jack CI, Lye M. Asthma in the elderly patient. Gerontology 1996; 42(2)61–68
   PubMedGoogle Scholar
• Schocken DD, Roth GS. Reduced beta-adrenergic receptor concentrations in ageing man. Nature 1977; 267(5614)856–858
   PubMedGoogle Scholar
• Palmqvist M, Arvidsson P, Beckman O, Peterson S, Lotvall J. Onset of bronchodilation of budesonide/formoterol vs. salmeterol/fluticasone in single inhalers. Pulm Pharmacol Ther 2001; 14(1)29–34
   PubMed Web of Science ®Google Scholar
• Fink JB. Metered-dose inhalers, dry powder inhalers, and transitions. Respir Care 2000; 45(6)623–635
   PubMedGoogle Scholar
• Van den Berg NJ, Ossip MS, Hederos CA, Anttila H, Ribeiro BL, Davies PI. Salmeterol/fluticasone propionate (50/100 µg) in combination in a diskus inhaler (seretide) is effective and safe in children with asthma. Pediatr Pulmonol 2000; 30(2)97–105
   PubMedGoogle Scholar
• Sheth KK, Kelly HW, Mitchell BH. Innovations in Dry Powder Inhalers [monograph]. Meniscus, Bala Cynwyd, PA 2000
   Google Scholar
• Bateman ED, Silins V, Bogolubov M. Clinical equivalence of salmeterol/fluticasone propionate in combination (50/100 µg twice daily) when administered via a chlorofluorocarbon-free metered dose inhaler or dry powder inhaler to patients with mild-to-moderate asthma. Respir Med 2001; 95(2)136–146
   PubMed Web of Science ®Google Scholar
• Condemi JJ, Goldstein S, Kalberg C, Yancey S, Emmett A, Rickard K. The addition of salmeterol to fluticasone propionate versus increasing the dose of fluticasone propionate in patients with persistent asthma. Salmeterol study group. Ann Allergy Asthma Immunol 1999; 82(4)383–389
   PubMed Web of Science ®Google Scholar
• van Noord JA, Schreurs AJ, Mol SJ, Mulder PG. Addition of salmeterol versus doubling the dose of fluticasone propionate in patients with mild to moderate asthma. Thorax 1999; 54(3)207–212
   PubMed Web of Science ®Google Scholar
• Spencer CM, Jarvis B. Salmeterol/fluticasone propionate combination. Drugs 1999; 57(6)933–940
   PubMedGoogle Scholar
• D'Alonzo GE, Crocetti JG, Smolensky MH. Circadian rhythms in the pharmacokinetics and clinical effects of beta-agonist, theophylline, and anticholinergic medications in the treatment of nocturnal asthma. Chronobiol Int 1999; 16(5)663–682
   PubMed Web of Science ®Google Scholar
• Faurschou P, Engel AM, Haanaes OC. Salmeterol in two different doses in the treatment of nocturnal bronchial asthma poorly controlled by other therapies. Allergy 1994; 49(10)827–832
   PubMedGoogle Scholar
• Pincus DJ, Humeston TR, Martin RJ. Further studies on the chronotherapy of asthma with inhaled steroids: the effect of dosage timing on drug efficacy. J Allergy Clin Immunol 1997; 100(6 Pt 1)771–774
   PubMedGoogle Scholar
• 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(6 Pt 1)1108–1116
   PubMed Web of Science ®Google Scholar
• Shapiro G, Lumry W, Wolfe J, Given J, White MV, Woodring A, Baitinger L, House K, Prillaman B, Shah T. Combined salmeterol 50 µg and fluticasone propionate 250 µg in the diskus device for the treatment of asthma. Am J Respir Crit Care Med 2000; 161(2 Pt 1)527–534
   PubMedGoogle Scholar
• Aubier M, Pieters WR, Schlosser NJ, Steinmetz KO. Salmeterol/fluticasone propionate (50/500 µg) in combination in a diskus inhaler (seretide) is effective and safe in the treatment of steroid-dependent asthma. Respir Med 1999; 93(12)876–884
   PubMed Web of Science ®Google Scholar
• Bateman ED, Britton M, Carrillo AJ, Wixon X. Salmeterol/fluticasone combination inhaler. A new, effective and well tolerated treatment for asthma. Clin Drug Invest 1998; 16: 193–201
   PubMed Web of Science ®Google Scholar
• Chapman KR, Ringdal N, Backer V, Palmqvist M, Saarelainen S, Briggs M. Salmeterol and fluticasone propionate (50/250 µg) administered via combination diskus inhaler: as effective as when given via separate diskus inhalers. Can Respir J 1999; 6(1)45–51
   PubMedGoogle Scholar
• Markham A, Jarvis B. Inhaled salmeterol/fluticasone propionate combination: a review of its use in persistent asthma. Drugs 2000; 60(5)1207–1233
   PubMedGoogle Scholar
• Centanni S, Carlucci P, Santus P, Boveri B, Tarricone D, Fiorentini C, Lombardi F, Cazzola M. Non-pulmonary effects induced by the addition of formoterol to budesonide therapy in patients with mild or moderate persistent asthma. Respiration 2000; 67(1)60–64
   PubMedGoogle Scholar
• Nelson HS, Busse WW, Kerwin E, Church N, Emmett A, Rickard K, Knobil K. Fluticasone propionate/salmeterol combination provides more effective asthma control than low-dose inhaled corticosteroid plus montelukast. J Allergy Clin Immunol 2000; 106(6)1088–1095
   PubMed Web of Science ®Google Scholar
• Jenkins C, Woolcock AJ, Saarelainen P, Lundback B, James MH. Salmeterol/fluticasone propionate combination therapy 50/250 µg twice daily is more effective than budesonide 800 µg twice daily in treating moderate to severe asthma. Respir Med 2000; 94(7)715–723
   PubMedGoogle Scholar
• Kraft M. The distal airways: are they important in asthma?. Eur Respir J 1999; 14(6)1403–1417
   PubMed Web of Science ®Google Scholar
• Greening AP, Ind PW, Northfield M, Shaw G. 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)219–224
   PubMed Web of Science ®Google Scholar
• Pauwels RA, Lofdahl CG, Postma DS, Tattersfield AE, O'Byrne P, Barnes PJ, Ullman A. 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)1405–1411
   PubMed Web of Science ®Google Scholar