Mometasone furoate dry powder inhaler: a once-daily inhaled corticosteroid for the treatment of persistent asthma

References

• National Asthma Education and Prevention Program. Expert panel report 3: guidelines for the diagnosis and management of asthma, 2007. Available at: http://www.nhlbi.nih.gov/guidelines/asthma/asthupdt.htm [last accessed 2007 August 29]
   Google Scholar
• Global Initiative for Asthma. Global strategy for asthma management and prevention, 2006. Available at: http://www.ginaasthma.org [last accessed 2007 April 19]
   Google Scholar
• US Food and Drug Administration. FDA Public Health Advisory: Serevent Diskus (salmeterol xinafoate inhalation powder), Advair Diskus (fluticasone propionate & salmeterol inhalation powder), Foradil Aerolizer (formoterol fumarate inhalation powder), 2005. Available at: http://www.fda.gov/cder/drug/advisory/LABA.htm [last accessed 2006 December 4]
   Google Scholar
• Leone FT, Fish JE, Szefler SJ, West SL. Systematic review of the evidence regarding potential complications of inhaled corticosteroid use in asthma [collaboration of American College of Chest Physicians, American Academy of Allergy, Asthma, and Immunology, and American College of Allergy, Asthma, and Immunology]. Chest 2003;124:2329–40
   PubMed Web of Science ®Google Scholar
• Wardlaw AJ. Molecular basis for selective eosinophil trafficking in asthma: a multistep paradigm. J Allergy Clin Immunol 1999;104:917–26
   PubMed Web of Science ®Google Scholar
• Walsh GM, Sexton DW, Blaylock MG. Corticosteroids, eosinophils and bronchial epithelial cells: new insights into the resolution of inflammation in asthma. J Endocrinol 2003;178:37–43
   Google Scholar
• Lai CK, Ho AS, Chan CH, et al. Interleukin-5 messenger RNA expression in peripheral blood CD4+ cells in asthma. J Allergy Clin Immunol 1996;97:1320–8
   PubMed Web of Science ®Google Scholar
• Kips JC. Cytokines in asthma. Eur Respir J Suppl 2001;34:24s–33s
   Google Scholar
• Holgate ST, Bodey KS, Janezic A, et al. Release of RANTES, MIP-1 alpha, and MCP-1 into asthmatic airways following endo bronchial allergen challenge. Am J Respir Crit Care Med 1997;156:1377–83
   PubMed Web of Science ®Google Scholar
• Ponath PD, Qin S, Ringler DJ, et al. Cloning of the human eosinophil chemoattractant, eotaxin. Expression, receptor binding, and functional properties suggest a mechanism for the selective recruitment of eosinophils. J Clin Invest 1996;97: 604–12
   Google Scholar
• Taha RA, Minshall EM, Miotto D, et al. Eotaxin and monocyte chemotactic protein-4 mRNA expression in small airways of asthmatic and nonasthmatic individuals. J Allergy Clin Immunol 1999;103:476–83
   PubMed Web of Science ®Google Scholar
• Miotto D, Christodoulopoulos P, Olivenstein R, et al. Expression of IFN-gamma-inducible protein; monocyte chemotactic proteins 1, 3, and 4; and eotaxin in TH1- and TH2-mediated lung diseases. J Allergy Clin Immunol 2001;107:664–70
   PubMed Web of Science ®Google Scholar
• Haley KJ, Sunday ME, Wiggs BR, et al. Inflammatory cell distribution within and along asthmatic airways. Am J Respir Crit Care Med 1998;158:565–72
   PubMed Web of Science ®Google Scholar
• Kraft M, Djukanovic R, Wilson S, et al. Alveolar tissue inflammation in asthma. Am J Respir Crit Care Med 1996;154:1505–10
   PubMed Web of Science ®Google Scholar
• Kraft M, Martin RJ, Wilson S, et al. Lymphocyte and eosinophil influx into alveolar tissue in nocturnal asthma. Am J Respir Crit Care Med 1999;159:228–34
   PubMed Web of Science ®Google Scholar
• Turner-Warwick M. Epidemiology of nocturnal asthma. Am J Med 1988;85:6–8
   PubMed Web of Science ®Google Scholar
• Martin RJ. Nocturnal asthma. Structure and function. Chest 1995;107:158S–161S
   Google Scholar
• Smolensky MH, Reinberg AE, Martin RJ, Haus E. Clinical chronobiology and chronotherapeutics with applications to asthma. Chronobiol Int 1999;16:539–63
   PubMed Web of Science ®Google Scholar
• Sutherland ER. Nocturnal asthma: underlying mechanisms and treatment. Curr Allergy Asthma Rep 2005;5:161–7
   PubMed Web of Science ®Google Scholar
• Barnes PJ. Molecular mechanisms of steroid action in asthma. J Allergy Clin Immunol 1996;97:159–68
   PubMed Web of Science ®Google Scholar
• Umland SP, Schleimer RP, Johnston SL. Review of the molecular and cellular mechanisms of action of glucocorticoids for use in asthma. Pulm Pharmacol Ther 2002;15:35–50
   Google Scholar
• Lilly CM, Nakamura H, Kesselman H, et al. Expression of eotaxin by human lung epithelial cells: induction by cytokines and inhibition by glucocorticoids. J Clin Invest 1997;99: 1767–73
   PubMed Web of Science ®Google Scholar
• Spoelstra FM, Kauffman HF, Hovenga H, et al. Effects of budesonide and formoterol on eosinophil activation induced by human lung fibroblasts. Am J Respir Crit Care Med 2000;162:1229–34
   PubMed Web of Science ®Google Scholar
• Wallen N, Kita H, Weiler D, Gleich GJ. Glucocorticoids inhibit cytokine-mediated eosinophil survival. J Immunol 1991;147:3490–5
   PubMed Web of Science ®Google Scholar
• Zhang X, Moilanen E, Adcock IM, et al. Divergent effect of mometasone on human eosinophil and neutrophil apoptosis. Life Sci 2002;71:1523–34
   PubMed Web of Science ®Google Scholar
• Wang JH, Trigg CJ, Devalia JL, et al. Effect of inhaled beclomethasone dipropionate on expression of proinflammatory cyto kines and activated eosinophils in the bronchial epithelium of patients with mild asthma. J Allergy Clin Immunol 1994;94:1025–34
   PubMed Web of Science ®Google Scholar
• Spahn JD, Landwehr LP, Nimmagadda S, et al. Effects of glucocorticoids on lymphocyte activation in patients with steroid-sensitive and steroid-resistant asthma. J Allergy Clin Immunol 1996;98:1073–9
   PubMed Web of Science ®Google Scholar
• DeKruyff RH, Fang Y, Umetsu DT. Corticosteroids enhance the capacity of macrophages to induce Th2 cytokine synthesis in CD4+ lymphocytes by inhibiting IL-12 production. J Immunol 1998;160: 2231–7
   Google Scholar
• Kwon OJ, Jose PJ, Robbins RA, et al. Glucocorticoid inhibition of RANTES expression in human lung epithelial cells. Am J Respir Cell Mol Biol 1995;12:488–96
   PubMed Web of Science ®Google Scholar
• Kwon S, Newcomb RL, George SC. Mechanisms of synergistic cytokine-induced nitric oxide production in human alveolar epithelial cells. Nitric Oxide 2001;5:534–46
   PubMed Web of Science ®Google Scholar
• Lantero S, Sacco O, Scala C, et al. Eosinophil locomotion and the release of IL-3 and IL-5 by allergen-stimulated mononuclear cells are effectively downregulated in vitro by budesonide. Clin Exp Allergy 1996;26:656–64
   PubMed Web of Science ®Google Scholar
• Robbins RA, Barnes PJ, Springall DR, et al. Expression of inducible nitric oxide in human lung epithelial cells. Biochem Biophys Res Commun 1994;203:209–18
   PubMed Web of Science ®Google Scholar
• Olivieri D, Chetta A, Del Donno M, et al. Effect of short-term treatment with low-dose inhaled fluticasone propionate on airway inflammation and remodeling in mild asthma: a placebo-controlled study. Am J Respir Crit Care Med 1997;155: 1864–71
   PubMed Web of Science ®Google Scholar
• Stellato C, Atsuta J, Bickel CA, Schleimer RP. An in vitro comparison of commonly used topical glucocorticoid preparations. J Allergy Clin Immunol 1999;104:623–9
   PubMed Web of Science ®Google Scholar
• Atsuta J, Plitt J, Bochner BS, Schleimer RP. Inhibition of VCAM-1 expression in human bronchial epithelial cells by gluco corticoids. Am J Respir Cell Mol Biol 1999;20:643–50
   PubMed Web of Science ®Google Scholar
• Wilson SJ, Wallin A, Della-Cioppa G, et al. Effects of budesonide and formoterol on NF-kappaB, adhesion molecules, and cytokines in asthma. Am J Respir Crit Care Med 2001;164:1047–52
   Google Scholar
• Sabatini F, Silvestri M, Sale R, et al. Modulation of the constitutive or cytokine-induced bronchial epithelial cell functions in vitro by fluticasone propionate. Immunol Lett 2003;89:215–24
   PubMed Web of Science ®Google Scholar
• Peters-Golden M, Sampson AP. Cysteinyl leukotriene interactions with other mediators and with glucocorticosteroids during airway inflammation. J Allergy Clin Immunol 2003;111: S37–S42 [discussion S3–S8]
   Google Scholar
• Kleinert H, Euchenhofer C, Ihrig-Biedert I, Forstermann U. Glucocorticoids inhibit the induction of nitric oxide synthase II by down-regulating cytokine-induced activity of transcription factor nuclear factor-kappa B. Mol Pharmacol 1996;49:15–21
   Google Scholar
• Lim S, Jatakanon A, John M, et al. Effect of inhaled budesonide on lung function and airway inflammation. Assessment by various inflammatory markers in mild asthma. Am J Respir Crit Care Med 1999;159:22–30
   Google Scholar
• Lanz MJ, Eisenlohr C, Llabre MM, et al. The effect of low-dose inhaled fluticasone propionate on exhaled nitric oxide in asthmatic patients and comparison with oral zafirlukast. Ann Allergy Asthma Immunol 2001;87:283–8
   PubMed Web of Science ®Google Scholar
• Minshall EM, Hogg JC, Hamid QA. Cytokine mRNA expression in asthma is not restricted to the large airways. J Allergy Clin Immunol 1998;101:386–90
   Google Scholar
• Adcock IM, Gilbey T, Gelder CM, et al. Glucocorticoid receptor localization in normal and asthmatic lung. Am J Respir Crit Care Med 1996;154:771–82
   PubMed Web of Science ®Google Scholar
• Vachier I, Chiappara G, Vignola AM, et al. Glucocorticoid receptors in bronchial epithelial cells in asthma. Am J Respir Crit Care Med 1998;158:963–70
   PubMed Web of Science ®Google Scholar
• Encio IJ, Detera-Wadleigh SD. The genomic structure of the human glucocorticoid receptor. J Biol Chem 1991;266:7182–8
   PubMed Web of Science ®Google Scholar
• Rahman I, MacNee W. Role of transcription factors in inflammatory lung diseases. Thorax 1998;53:601–12
   PubMed Web of Science ®Google Scholar
• Barnes PJ, Adcock I. Anti-inflammatory actions of steroids: molecular mechanisms. Trends Pharmacol Sci 1993;14:436–41
   PubMed Web of Science ®Google Scholar
• Hayashi R, Wada H, Ito K, Adcock IM. Effects of glucocorticoids on gene transcription. Eur J Pharmacol 2004;500:51–62
   PubMed Web of Science ®Google Scholar
• Imai E, Miner JN, Mitchell JA, et al. Glucocorticoid receptor-cAMP response element-binding protein interaction and the response of the phosphoenolpyruvate carboxykinase gene to glucocorticoids. J Biol Chem 1993;268:5353–6
   PubMed Web of Science ®Google Scholar
• Barnes PJ. Effect of beta-agonists on inflammatory cells. J Allergy Clin Immunol 1999;104:S10–S17
   Google Scholar
• Smith CL, Kreutner W. In vitro glucocorticoid receptor binding and transcriptional activation by topically active glucocorticoids. Arzneim-Forsch 1998;48:956–60
   PubMed Web of Science ®Google Scholar
• Austin RJ, Maschera B, Walker A, et al. Mometasone furoate is a less specific glucocorticoid than fluticasone propionate. Eur Respir J 2002;20:1386–92
   PubMed Web of Science ®Google Scholar
• Barton BE, Jakway JP, Smith SR, Siegel MI. Cytokine inhibition by a novel steroid, mometasone furoate. Immunopharmacol Immunotoxicol 1991;13:251–61
   PubMed Web of Science ®Google Scholar
• Papi A, Papadopoulos NG, Degitz K, et al. Corticosteroids inhibit rhinovirus-induced intercellular adhesion molecule-1 up-regula tion and promoter activation on respiratory epithelial cells. J Allergy Clin Immunol 2000;105:318–26
   PubMed Web of Science ®Google Scholar
• Murray CS, Simpson A, Custovic A. Allergens, viruses, and asthma exacerbations. Proc Am Thorac Soc 2004;1:99–104
   Google Scholar
• Chapman RW, Sehring SJ, Garlisi CG, et al. Anti-inflammatory activity of inhaled mometasone furoate in allergic mice. Arzneimittelforschung 1998;48:384–91
   PubMed Web of Science ®Google Scholar
• Inman MD, Watson RM, Rerecich T, et al. Dose-dependent effects of inhaled mometasone furoate on airway function and inflammation after allergen inhalation challenge. Am J Respir Crit Care Med 2001;164:569–74
   PubMed Web of Science ®Google Scholar
• Affrime MB, Cuss F, Padhi D, et al. Bioavailability and metabolism of mometasone furoate following administration by metered-dose and dry-powder inhalers in healthy human volunteers. J Clin Pharmacol 2000;40:1227–36
   PubMed Web of Science ®Google Scholar
• Affrime MB, Kosoglou T, Thonoor CM, et al. Mometasone furoate has minimal effects on the hypothalamic–pituitary– adrenal axis when delivered at high doses. Chest 2000;118: 1538–46
   PubMed Web of Science ®Google Scholar
• Affrime M, Kosoglou T. The pharmacokinetics of mometasone furoate administered by dry powder inhaler following single and multiple dosing in patients with mild to moderate persistent asthma [Abstract 346]. J Allergy Clin Immunol 2001;107:S104
   Web of Science ®Google Scholar
• Bernstein DI, Berkowitz RB, Chervinsky P, et al. Dose-ranging study of a new steroid for asthma: mometasone furoate dry powder inhaler. Respir Med 1999;93:603–12
   PubMed Web of Science ®Google Scholar
• Bousquet J, D’Urzo A, Hebert J, et al. Comparison of the efficacy and safety of mometasone furoate dry powder inhaler to budesonide Turbuhaler. Eur Respir J 2000;16:808–16
   PubMed Web of Science ®Google Scholar
• O’Connor B, Bonnaud G, Haahtela T, et al. Dose-ranging study of mometasone furoate dry powder inhaler in the treatment of moderate persistent asthma using fluticasone propionate as an active comparator. Ann Allergy Asthma Immunol 2001;86: 397–404
   Google Scholar
• Nayak AS, Banov C, Corren J, et al. Once-daily mometasone furoate dry powder inhaler in the treatment of patients with persistent asthma. Ann Allergy Asthma Immunol 2000;84: 417–24
   PubMed Web of Science ®Google Scholar
• Kemp JP, Berkowitz RB, Miller SD, et al. Mometasone furoate administered once daily is as effective as twice-daily administration for treatment of mild-to-moderate persistent asthma. J Allergy Clin Immunol 2000;106:485–92
   PubMed Web of Science ®Google Scholar
• Noonan M, Karpel JP, Bensch GW, et al. Comparison of once-daily to twice-daily treatment with mometasone furoate dry powder inhaler. Ann Allergy Asthma Immunol 2001;86:36–43
   PubMed Web of Science ®Google Scholar
• Bensch GW, Prenner B, Berkowitz R, et al. Once-daily evening administration of mometasone furoate in asthma treatment initiation. Ann Allergy Asthma Immunol 2006;96:533–40
   PubMed Web of Science ®Google Scholar
• D’Urzo A, Karpel JP, Busse WW, et al. Efficacy and safety of mometasone furoate administered once-daily in the evening in patients with persistent asthma dependent on inhaled corticosteroids. Curr Med Res Opin 2005;21:1281–9
   Google Scholar
• Karpel JP, Busse WW, Noonan MJ, et al. Effects of mometasone furoate given once daily in the evening on lung function and symptom control in persistent asthma. Ann Pharmacother 2005;39:1977–83
   PubMed Web of Science ®Google Scholar
• Fish JE, Karpel JP, Craig TJ, et al. Inhaled mometasone furoate reduces oral prednisone requirements while improving respiratory function and health-related quality of life in patients with severe persistent asthma. J Allergy Clin Immunol 2000;106:852–60
   PubMed Web of Science ®Google Scholar
• Wardlaw A, Larivee P, Eller J, et al. Efficacy and safety of mometasone furoate dry powder inhaler vs fluticasone propionate metered-dose inhaler in asthma subjects previously using fluticasone propionate. Ann Allergy Asthma Immunol 2004;93:49–55
   PubMed Web of Science ®Google Scholar
• Asmanex® Twisthaler® (mometasone furoate inhalation powder). Full prescribing information, Schering Corporation, Kenilworth (NJ) 2005
   Google Scholar
• Nayak AS, Lampl KL, Segall N, et al. Long-term use of once-daily mometasone furoate is effective and well tolerated in patients with mild to moderate persistent asthma. 57th annual meeting of the American Academy of Allergy, Asthma and Immunology; March 16–21, 2001; New Orleans (LA)
   Google Scholar
• Nathan RA, Nayak AS, Graft DF, et al. Mometasone furoate: efficacy and safety in moderate asthma compared with beclomethasone dipropionate. Ann Allergy Asthma Immunol 2001;86:203–10
   PubMed Web of Science ®Google Scholar
• Corren J, Berkowitz R, Murray JJ, Prenner B. Comparison of once-daily mometasone furoate versus once-daily budesonide in patients with moderate persistent asthma. Int J Clin Pract 2003;57:567–72
   PubMed Web of Science ®Google Scholar
• Karpel JP, Nayak A, Lumry W, et al. Inhaled mometasone furoate reduces oral prednisone usage and improves lung function in severe persistent asthma. Respir Med 2006;101: 628–37
   PubMed Web of Science ®Google Scholar
• Murray J, Busse W, Dockhorn R, et al. Long-term safety of mometasone furoate (MF) administered by dry powder inhaler (DPI) in patients with moderate persistent asthma. Eur Respir J 2000;16:280s–281s
   Google Scholar
• Lipworth BJ, Seckl JR. Measures for detecting systemic bioactivity with inhaled and intranasal corticosteroids. Thorax 1997;52:476–82
   PubMed Web of Science ®Google Scholar
• Derendorf H, Daley-Yates PT, Pierre LN, Efthimiou J. Bioavailability and metabolism of mometasone furoate: pharmacology versus methodology. J Clin Pharmacol 2002;42:383–7
   PubMed Web of Science ®Google Scholar
• Fardon TC, Lee DK, Haggart K, et al. Adrenal suppression with dry powder formulations of fluticasone propionate and mometasone furoate. Am J Respir Crit Care Med 2004;170:960–6
   PubMed Web of Science ®Google Scholar
• Chrousos GP, Ghaly L, Shedden A, et al. Effects of mometasone furoate dry powder inhaler and beclomethasone dipropionate hydrofluoroalkane and chlorofluorocarbon on the hypothalamic– pituitary–adrenal axis in asthmatic subjects. Chest 2005;128:70–7
   PubMed Web of Science ®Google Scholar
• Pedersen S. Do inhaled corticosteroids inhibit growth in children? Am J Respir Crit Care Med 2001;164:521–35
   PubMed Web of Science ®Google Scholar
• Israel E, Banerjee TR, Fitzmaurice GM, et al. Effects of inhaled glucocorticoids on bone density in premenopausal women. New Engl J Med 2001;345:941–7
   PubMed Web of Science ®Google Scholar
• Pedersen S, Agertoft L, Lee T, Staudinger H. Lower-leg growth in children with asthma during treatment with inhaled corticosteroids. J Allergy Clin Immunol 2003;111:S269
   Google Scholar
• Skoner D, Dunn M, Lee T. Effects of mometasone furoate dry powder inhaler on growth velocity and hypothalamic–pituitary– adrenal axis function in children with asthma [abstract]. Am J Respir Crit Care Med 2003;167:A272
   Google Scholar
• Lemanske R, Lockey R, Murphy K. Effects of one year of treatment with mometasone furoate metered dose inhaler (MFMDI) on growth in children with asthma [abstract]. Eur Respir J 2004;24:378s
   Google Scholar
• Childhood Asthma Management Program Research Group. Long-term effects of budesonide or nedocromil in children with asthma. New Engl J Med 2000;343:1054–63
   PubMed Web of Science ®Google Scholar
• Data on file (accession number 2323899; protocol C98–302). Schering-Plough, Kenilworth (NJ).
   Google Scholar
• Wong CA, Walsh LJ, Smith CJ, et al. Inhaled corticosteroid use and bone-mineral density in patients with asthma. Lancet 2000;355:1399–403
   PubMed Web of Science ®Google Scholar
• Tattersfield AE, Town GI, Johnell O, et al. Bone mineral density in subjects with mild asthma randomised to treatment with inhaled corticosteroids or non-corticosteroid treatment for two years. Thorax 2001;56:272–8
   PubMed Web of Science ®Google Scholar
• Guidance for industry: metered dose inhaler (MDI) and dry powder inhaler (DPI) Drug Products Chemistry, Manufacturing, and Controls Documentation, 1998 May 8, 2001. Available at: http://www.fda.gov/cder/guidance/2180dft.htm [last accessed 2007 February 5]
   Google Scholar
• Yang T, Li S, Wyka B, et al. Assessment of dose uniformity with the new mometasone furoate dry powder inhaler (MF-DPI). Eur Respir J 1999;14:62S
   Google Scholar
• Yang TT, Li S, Wyka B, Kenyon D. Drug delivery performance of the mometasone furoate dry powder inhaler. J Aerosol Med 2001;14:487–94
   PubMedGoogle Scholar
• Newman SP, Busse WW. Evolution of dry powder inhaler design, formulation, and performance. Respir Med 2002;96:293–304
   PubMed Web of Science ®Google Scholar
• Kenyon D, Schenkel E, Miller D, Harrison J. Reproducible airflow profiles at two separate clinic visits with patients using the new mometasone furoate dry powder inhaler. Eur Respir J 2000;16:94S
   Google Scholar
• Schenkel E, Miller D, Angelini B, et al. Assessment of inspiratory flow rates and rise time data in patients with asthma. American College of Allergy, Asthma & Immunology annual meeting. Chicago (IL) 1999
   Google Scholar
• Umland SP, Nahrebne DK, Razac S, et al. The inhibitory effects of topically active glucocorticoids on IL-4, IL-5, and interferon-gamma production by cultured primary CD4+ T cells. J Allergy Clin Immunol 1997;100:511–9
   PubMed Web of Science ®Google Scholar
• Crocker IC, Zhou CY, Bewtra AK, et al. Glucocorticosteroids inhibit leukotriene production. Ann Allergy Asthma Immunol 1997;78:497–505
   PubMed Web of Science ®Google Scholar