Comparison of the systemic bioavailability of mometasone furoate after oral inhalation from a mometasone furoate/formoterol fumarate metered-dose inhaler versus a mometasone furoate dry-powder inhaler in patients with chronic obstructive pulmonary disease

International Journal of COPD

Volumn 8, Issue , 2013, Pages 107-116

  Kosoglou, Teddy ^a   Hubbell, James ^a   Xuan, Fengjuan ^a   Cutler, David L ^a   Meehan, Alan G ^a   Kantesaria, Bhavna ^a   Wittmer, Bret A ^b  

^a MERCK RESEARCH LABORATORIES   (United States)

^b Commonwealth Biomedical Research LLC ^*  (United States)

Author keywords

Chronic obstructive pulmonary disease; Dry powder inhaler; Metered dose inhaler; Mometasone furoate; Pharmacokinetics; Systemic exposure

Indexed keywords

FORMOTEROL FUMARATE; FORMOTEROL FUMARATE PLUS MOMETASONE FUROATE; MOMETASONE FUROATE; SALBUTAMOL; TWISTHALER; UNCLASSIFIED DRUG; ZENHALE;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; CHRONIC OBSTRUCTIVE LUNG DISEASE; CLINICAL ARTICLE; CONTROLLED STUDY; CROSSOVER PROCEDURE; DISTRIBUTION VOLUME; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG INDUCED HEADACHE; DRUG SELF ADMINISTRATION; DYSPEPSIA; ELECTROCARDIOGRAM; FEMALE; FORCED EXPIRATORY VOLUME; HEMATOLOGICAL PARAMETERS; HUMAN; LIMIT OF DETECTION; LIMIT OF QUANTITATION; LUNG FUNCTION; MALE; MAXIMUM PLASMA CONCENTRATION; METERED DOSE INHALER; MORNING DOSAGE; POWDER INHALER; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SINGLE DRUG DOSE; SMOKING; TIME TO MAXIMUM PLASMA CONCENTRATION; VITAL SIGN;

CHRONIC OBSTRUCTIVE PULMONARY DISEASE; DRY-POWDER INHALER; METERED-DOSE INHALER; MOMETASONE FUROATE; PHARMACOKINETICS; SYSTEMIC EXPOSURE;

AGED; ANTI-INFLAMMATORY AGENTS; BRONCHODILATOR AGENTS; CROSS-OVER STUDIES; DRUG COMBINATIONS; DRY POWDER INHALERS; ETHANOLAMINES; FEMALE; HUMANS; MALE; METERED DOSE INHALERS; MIDDLE AGED; PREGNADIENEDIOLS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE;

EID: 84874997584     PISSN: 11769106     EISSN: 11782005     Source Type: Journal    
DOI: 10.2147/COPD.S36592     Document Type: Article

References (26)

1. American Thoracic Society/European Respiratory Society Task Force. Standards for the Diagnosis and Management of Patients with COPD 2004. New York, NY: American Thoracic Society/European Respiratory Society Task Force; 2005.
2. National Collaborating Centre for Chronic Conditions. Chronic obstructive pulmonary disease: national clinical guideline on management of chronic obstructive pulmonary disease in adults in primary and secondary care. Thorax. 2004;59 Suppl 1:1-232.
3. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. Global Initiative for Chronic Obstructive Lung Disease, Inc; 2011. Available from: http://www.goldcopd.org/uploads/users/files/GOLD_Report_2011_Feb21.pdf. Accessed August 7, 2011.
4. GINA - the Global Initiative for Asthma [webpage on the Internet]. Global strategy for asthma management and prevention. National Heart, Lung, and Blood Institute. Global Initiative for Asthma (GINA); 2010. Available from: http://www.ginasthma.org/guideline-report-2010.html. Accessed August 7, 2011.
5. NHLBI, Diagnosis and Management of Asthma [webpage on the Internet]. Expert Panel Report 3 (EPR3): Guidelines for the diagnosis and management of asthma. National Heart Lung and Blood Institute; updated 2012. Available from: http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.htm. Accessed August 7, 2011.
6. 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(9):603-612.
7. 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. 2007;101(3):628-637.
8. 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(1):36-43.
9. Doherty DE, Tashkin DP, Kerwin E, et al. Effects of mometasone furoate/formoterol fumarate fixed-dose combination formulation on chronic obstructive pulmonary disease (COPD): results from a 52-week Phase III trial in subjects with moderate-to-very severe COPD. Int J Chron Obstruct Pulmon Dis. 2012;7:57-71.
10. Tashkin DP, Doherty DE, Kerwin E, et al. Efficacy and safety characteristics of mometasone furoate/formoterol fumarate fixed-dose combination in subjects with moderate to very severe COPD: findings from pooled analysis of two randomized, 52-week placebo-controlled trials. Int J Chron Obstruct Pulmon Dis. 2012;7:73-86.
11. LaForce C, Prenner BM, Andriano K, Lavecchia C, Yegen U. Efficacy and safety of formoterol delivered via a new multidose dry powder inhaler (Certihaler) in adolescents and adults with persistent asthma. J Asthma. 2005;42(2):101-106.
12. Singh SD, Whale C, Houghton N, Daley-Yates P, Kirby SM, Woodcock AA. Pharmacokinetics and systemic effects of inhaled fluticasone propionate in chronic obstructive pulmonary disease. Br J Clin Pharmacol. 2003;55(4):375-381.
13. Edsbäcker S, Wollmer P, Selroos O, Borgström L, Olsson B, Ingelf J. Do airway clearance mechanisms influence the local and systemic effects of inhaled corticosteroids? Pulm Pharmacol Ther. 2008;21(2):247-258.
14. Tronde A, Gillen M, Borgström L, Lötvall J, Ankerst J. Pharmacokinetics of budesonide and formoterol administered via 1 pressurized metered-dose inhaler in patients with asthma and COPD. J Clin Pharmacol. 2008;48(11):1300-1308.
15. Symbicort® (budesonide/formaterol fumarate dehydrate) [package insert]. Wilmington, DE: AstraZeneca; 2010.
16. Zeidler M, Corren J, Tashkin DP. Use of mometasone furoate administered via a dry powder inhaler in the treatment of asthma. Curr Med Res Opin. 2010;26(6):1295-1305.
17. Nathan RA, Nolte H, Pearlman DS; for P04334 Study Investigators. Twenty-six-week efficacy and safety study of mometasone furoate/formoterol 200/10 microg combination treatment in patients with persistent asthma previously receiving medium-dose inhaled corticosteroids. Allergy Asthma Proc. 2010;31(4):269-279.
18. Weinstein SF, Murphy KR, Corren J, Nolte H, White MV. Efficacy and safety of medium and high doses of mometasone furoate/formoterol (MF/F) combination treatment in subjects with severe persistent asthma [abstract]. J Allergy Clin Immunol. 2010;125:AB196.
19. Weinstein SF, Corren J, Murphy K, Nolte H, White M; Study Investigators of P04431. Twelve-week efficacy and safety study of mometasone furoate/formoterol 200/10 microg and 400/10 microg combination treatments in patients with persistent asthma previously receiving high-dose inhaled corticosteroids. Allergy Asthma Proc. 2010; 31(4):280-289.
20. Wales D, Makker H, Kane J, McDowell P, O'Driscoll BR. Systemic bioavailability and potency of high-dose inhaled corticosteroids: a comparison of four inhaler devices and three drugs in healthy adult volunteers. Chest. 1999;115(5):1278-1284.
21. Clark DJ, Lipworth BJ. Effect of multiple actuations, delayed inhalation and antistatic treatment on the lung bioavailability of salbutamol via a spacer device. Thorax. 1996;51(10):981-984.
22. Maspero J, Cherrez I, Nolte H. Long-term safety and tolerability of two doses of mometasone furoate/formoterol (MF/F) combination, administered via a metered-dose inhaler, for the treatment of moderate-to-severe persistent asthma. J Allergy Clin Immunol. 2009;123(2):S159.
23. Maspero JF, Nolte H, Cherrez-Ojeda I; P04139 Study Group. Long-term safety of mometasone furoate/formoterol combination for treatment of patients with persistent asthma. J Asthma. 2010;47(10):1106-1115.
24. Adams N, Bestall J, Jones P. Budesonide at different doses for chronic asthma. Cochrane Database Syst Rev. 2001;4:CD003271.
25. Adams NP, Bestall JC, Jones P, Lasserson TJ, Griffiths B, Cates CJ. Fluticasone at different doses for chronic asthma in adults and children. Cochrane Database Syst Rev. 2008;4:CD003534.
26. Committee for Medicinal Products for Human Use (CHMP). Guideline on the Requirements for Clinical Documentation for Orally Inhaled Products (OIP) Including the Requirements for Demonstration of T{stroke}herapeutic Equivalence between Two Inhaled Products for Use in the Treatment of Asthma and Chronic Obstructive Pulmonary Disease (COPD) in Adults and for Use in the Treatment of Asthma in Children and Adolescents. London: European Medicines Agency; 2009. Available from: http://www.ema.europa.eu/ema/pages/includes/document/open_ document.jsp?webContentId=WC500003504. Accessed August 7, 2011.