Abstract
The high prevalence of asthma in pediatric patients underscores the need for effective and safe treatment in this population. Current treatment guidelines recommend inhaled corticosteroids (ICSs) as a preferred treatment for the control of mild to moderate persistent asthma in patients of all ages, including young children. Clinical efficacy, systemic safety, and ease of use are desirable attributes of an ICS used to treat children with persistent asthma. Recently, mometasone furoate administered via a dry powder inhaler (MF-DPI) 110 μg once daily in the evening (delivered dose of 100 μg) was approved by the US FDA for the maintenance treatment of asthma in children 4–11 years of age.
Data from the clinical trial program for MF-DPI that establish the efficacy, long-term safety, and absence of systemic effects of the approved dosage in children with mild to moderate persistent asthma are reviewed. These findings indicate that once-daily dosing of MF-DPI in children aged 4–11 years significantly improves lung function and health-related quality of life while reducing rescue medication use and exacerbations despite previous treatment with other ICSs. MF-DPI is also well tolerated in children. Clinical trial results showed that, at the approved dosage, there are no effects on growth velocity or the hypothalamic-pituitary-adrenal axis. Results of pediatric studies are consistent with the clinical development program for adults and adolescents. In addition, once-daily dosing, established safety, and ease of use of MF-DPI may help to improve asthma management by addressing issues that inhibit proper adherence.
Similar content being viewed by others
References
Dey AN, Bloom B. Summary health statistics for US children: National Health Interview Survey, 2003. Washington, DC: US Department of Health and Human Services, 2005 Mar
National Asthma Education and Prevention Program. Expert panel report 3: guidelines for the diagnosis and management of asthma [online]. Available from URL: http://www.nhlbi.nih.gov/guidelines/asthma/index.htm [Accessed 2008 Apr 16]
Asmanex® Twisthaler® (mometasone furoate inhalation powder): US prescribing information. Whitehouse Station (NJ): Merck & Co., 2008
Yang TT, Li S, Wyka B, et al. Drug delivery performance of the mometasone furoate dry powder inhaler. J Aerosol Med 2001 winter; 14(4): 487–94
Skoner D, Gentile D. Children with mild asthma achieve peak inspiratory flow rates that allow adequate delivery of mometasone furoate from the Twisthaler® dry powder inhaler [abstract no. 28]. Annual Meeting of the American College of Allergy, Asthma, and Immunology; 2007 Nov 10–11; Dallas (TX)
Bensch GW, Prenner B, Berkowitz R, et al. Once-daily evening administration of mometasone furoate in asthma treatment initiation. Ann Allergy Asthma Immunol 2006 Apr; 96(4): 533–40
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 Aug; 21(8): 1281–9
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 Sep; 106(3): 485–92
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 Apr; 84(4): 417–24
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 Jan; 86(1): 36–43
Berger WE, Milgrom H, Chervinsky P, et al. Effects of treatment with mometasone furoate dry powder inhaler in children with persistent asthma. Ann Allergy Asthma Immunol 2006 Nov; 97(5): 672–80
Meltzer EO, Baena-Cagnani CE, Chervinsky P, et al. Once-daily mometasone furoate administered by dry powder inhaler for the treatment of children with persistent asthma. Pediatr Asthma, Allergy and Immunol 2007; 20(2): 67–81
Skoner D, Berger W. Mometasone furoate is effective in children with asthma: supporting evidence from clinical trials [abstract no. 710]. International Conference of the American Thoracic Society; 2008 May 16–21; Toronto (ON)
Data on file, Merck & Co., 2002
Noonan M, Leflein J, Corren J, et al. Long-term safety of mometasone furoate administered via a dry powder inhaler in children: results of an open-label study comparing mometasone furoate with beclomethasone dipropionate in children with persistent asthma. BMC Pediatr 2009 July 13; 9(1): 43 [online]. Available from URL: http://www.biomedcentral.com/1471-2431/9/43 [Accessed 2010 Jun 9]
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 no. 272]. International Conference of the American Thoracic Society; 2003 May 17–22; Seattle (WA)
Skoner DP, Gentile DA, Angelini B. Effect of therapeutic doses of mometasone furoate on cortisol levels in children with mild asthma. Allergy Asthma Proc 2010 Jan–Feb; 31(1): 10–9
Lemanske R, Lockey R, Murphy K. Effects of one year of treatment with mometasone furoate metered dose inhaler (MF-MDI) on growth in children with asthma [abstract no. 378]. European Respiratory Society Annual Congress; 2004 Sep 7–12; Glasgow
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 Sep; 93(9): 603–12
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 Feb; 86(2): 203–10
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 Nov; 106(5): 852–60
Corren J, Berkowitz R, Murray JJ, et al. Comparison of once-daily mometasone furoate versus once-daily budesonide in patients with moderate persistent asthma. Int J Clin Pract 2003 Sep; 57(7): 567–72
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 Dec; 39(12): 1977–83
Wardlaw A, Larivee P, Eller J, et al. Efficacy and safety of mometasone furoate dry powder inhaler versus fluticasone propionate metered-dose inhaler in asthma subjects previously using fluticasone propionate. Ann Allergy Asthma Immunol 2004 Jul; 93(1): 49–55
Zetterstrom O, Dahl R, Lindqvist A, et al. Comparable morning versus evening administration of once-daily mometasone furoate dry powder inhaler. Respir Med 2008 October; 102(10): 1406–11
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 Nov; 16(5): 808–16
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 Apr; 86(4): 397–404
Harnest U, Price D, Howes T, et al. Comparison of mometasone furoate dry powder inhaler and fluticasone propionate dry powder inhaler in patients with moderate to severe persistent asthma requiring high-dose inhaled corticosteroid therapy: findings from a noninferiority trial. J Asthma 2008 Apr; 45(3): 215–20
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(Abstract Suppl.): 280S–1S
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; 2001 Mar 16–21; New Orleans (LA)
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 Dec; 118(6): 1538–46
Milgrom H, Bender B, Ackerson L, et al. Noncompliance and treatment failure in children with asthma. J Allergy Clin Immunol 1996 Dec; 98 (6 Pt 1): 1051–7
Bauman LJ, Wright E, Leickly FE, et al. Relationship of adherence to pediatric asthma morbidity among inner-city children. Pediatrics 2002 Jul; 110 (1 Pt 1): e6
Wieshammer S, Dreyhaupt J. Dry powder inhalers: which factors determine the frequency of handling errors? Respiration 2008; 75(1): 18–25
Bender BG. Overcoming barriers to nonadherence in asthma treatment. J Allergy Clin Immunol 2002 Jun; 109Suppl. 6: S554–9
Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther 2001 Aug; 23(8): 1296–310
Hyland ME, Stahl E. Asthma treatment needs: a comparison of patients’ and health care professionals’ perceptions. Clin Ther 2004 Dec; 26(12): 2141–52
Modi AC, Quittner AL. Barriers to treatment adherence for children with cystic fibrosis and asthma: what gets in the way? J Pediatr Psychol 2006 Sep; 31(8): 846–58
Weiss K, Buxton M, Andersson FL, et al. Cost-effectiveness of early intervention with once-daily budesonide in children with mild persistent asthma: results from the START study. Pediatr Allergy Immunol 2006 May; 17Suppl. 17: 21–7
Horne R. Compliance, adherence, and concordance: implications for asthma treatment. Chest 2006 Jul; 130Suppl. 1: 65–72S
Williams LK, Pladevall M, Xi H, et al. Relationship between adherence to inhaled corticosteroids and poor outcomes among adults with asthma. J Allergy Clin Immunol 2004 Dec; 114(6): 1288–93
Acknowledgements
Medical writing and/or editorial assistance, funded by Merck & Co., was provided by Erin P. Scott, PhD. Dr Milgrom has served on speaker’s bureaus and advisory boards for Merck & Co., Novartis, and Genentech. He has received study support from Merck & Co., Genentech, Novartis, GlaxoSmithKline, Sepracor, AstraZeneca, and Sanofi-aventis.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Milgrom, H. Mometasone Furoate in Children with Mild to Moderate Persistent Asthma. Pediatr-Drugs 12, 213–221 (2010). https://doi.org/10.2165/11316220-000000000-00000
Published:
Issue Date:
DOI: https://doi.org/10.2165/11316220-000000000-00000