Population Pharmacokinetics of Inhaled Fluticasone Furoate and Vilanterol in Subjects with Chronic Obstructive Pulmonary Disease

European Journal of Drug Metabolism and Pharmacokinetics

Volumn 41, Issue 6, 2016, Pages 743-758

  Siederer, Sarah ^a   Allen, Ann ^a   Yang, Shuying ^a  

^a GLAXOSMITHKLINE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

FLUTICASONE FUROATE; FLUTICASONE FUROATE PLUS VILANTEROL; MOXIFLOXACIN; VILANTEROL; ANDROSTANE DERIVATIVE; BENZYL ALCOHOL DERIVATIVE; BETA 2 ADRENERGIC RECEPTOR STIMULATING AGENT; CHLOROBENZENE; FLUTICASONE FUROATE-VILANTEROL TRIFENATATE; GLUCOCORTICOID;

ADULT; AGE; AGED; AREA UNDER THE CURVE; ARTICLE; BODY WEIGHT; CHRONIC OBSTRUCTIVE LUNG DISEASE; CONTROLLED STUDY; DRUG ABSORPTION; DRUG CLEARANCE; DRUG ELIMINATION; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; META ANALYSIS (TOPIC); MODEL; MORNING DOSAGE; MULTICENTER STUDY (TOPIC); PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PHASE 4 CLINICAL TRIAL (TOPIC); PREDICTION; RACE DIFFERENCE; RANDOMIZED CONTROLLED TRIAL (TOPIC); SEX DIFFERENCE; SINGLE DRUG DOSE; SMOKING; ABSORPTION; ASIAN CONTINENTAL ANCESTRY GROUP; BIOAVAILABILITY; BIOLOGICAL MODEL; BLOOD; CAUCASIAN; CLINICAL TRIAL; COMPARATIVE STUDY; CROSSOVER PROCEDURE; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG COMBINATION; DRUG EFFECTS; DRUG INTERACTION; ETHNOLOGY; INHALATIONAL DRUG ADMINISTRATION; METABOLIC CLEARANCE RATE; METABOLISM; MIDDLE AGED; MULTICENTER STUDY; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL;

ABSORPTION, PHYSIOLOGICAL; ADMINISTRATION, INHALATION; ADRENERGIC BETA-2 RECEPTOR AGONISTS; ADULT; ANDROSTADIENES; ASIAN CONTINENTAL ANCESTRY GROUP; BENZYL ALCOHOLS; BIOLOGICAL AVAILABILITY; CHLOROBENZENES; CROSS-OVER STUDIES; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG COMBINATIONS; DRUG INTERACTIONS; EUROPEAN CONTINENTAL ANCESTRY GROUP; FEMALE; GLUCOCORTICOIDS; HUMANS; MALE; META-ANALYSIS AS TOPIC; METABOLIC CLEARANCE RATE; MIDDLE AGED; MODELS, BIOLOGICAL; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE;

EID: 84996558179     PISSN: 03787966     EISSN: 21070180     Source Type: Journal    
DOI: 10.1007/s13318-015-0303-4     Document Type: Article

References (20)

1. Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medical compliance. Clin Ther. 2001;23:1296–310.
2. Boscia JA, Pudi KK, Zvarich MT, Sanford L, Siederer SK, Crim C. Effect of once daily fluticasone furoate/vilanterol on 24 h pulmonary function in patients with chronic obstructive pulmonary disease: a randomized, three-way, incomplete block, cross-over study. Clin Ther. 2012;34:1656–66. doi:10.1016/j.clinthera.2012.06.005.
3. Lötvall J, Bakke PS, Bjermer L, Steinshamn S, Scott-Wilson C, Crim C, Sanford L, Haumann B. Efficacy and safety of 4 weeks’ treatment with combined fluticasone furoate/vilanterol in a single inhaler given once daily in COPD: a placebo-controlled randomised trial. BMJ Open. 2012;2:e000370. doi:10.1136/bmjopen-2011-000370.
4. Thorsson L, Dahlstrom K, Edsbacker S, Kallen A, Paulson J, Wiren J-E. Pharmacokinetics and systemic effects of inhaled fluticasone propionate in healthy subjects. Br J Clin Pharmacol. 1997;43:155–61.
5. Bernstein DI, Allen DB. Evaluation of tests of hypothalamic-pituitary-adrenal axis function used to measure effects of inhaled corticosteroids. Ann Allergy Asthma Immunol. 2007;98:118–27.
6. Salpeter SR, Ormiston TM, Salpeter EE. Cardiovascular effects of beta-agonists in patients with asthma and COPD: a meta-analysis. Chest. 2004;125:2309–21.
7. McKeage K. Fluticasone furoate/vilanterol: a review of its use in chronic obstructive pulmonary disease. Drugs. 2014;74:1509–22. doi:10.1007/s40265-014-0269-6.
8. Kempsford R, Allen A, Bareille P, Bishop H, Hamilton M, Cheesbrough A. The safety, tolerability, pharmacodynamics and pharmacokinetics of inhaled fluticasone furoate (FF) and vilanterol (VI) are unaffected by administration in combination. Eur Respir J. 2011;38(Suppl. 55):138s.
9. Ahn JE, Karlsson MO, Dunne A, Ludden TM. Likelihood based approaches to handling data below the quantification limit using NONMEM vilanterol. J Pharmacokinet Pharmacodyn. 2008;35:401–21. doi:10.1007/s10928-008-9094-4.
10. Kerwin EM, Scott-Wilson C, Sanford L, Rennard SI, Agusti A, Barnes N, Crim C. A randomised trial of fluticasone furoate/vilanterol (50/25 µg; 100/25 µg) on lung function in COPD. Respir Med. 2013;107(4):560–9.
11. Martinez FJ, Boscia J, Feldman G, Scott-Wilson C, Kilbride S, Fabbri L, Crim C, Calverley PMA. Fluticasone furoate/vilanterol (100/25; 200/25 µg) improves lung function in COPD: a randomised trial. Respir Med. 2013;107(4):550–9.
12. Kempsford R, Allen A, Kelly K, Saggu P, Crim C. A repeat-dose thorough QT study of inhaled fluticasone furoate (FF)/vilanterol (VI) combination in healthy subjects. Br J Clin Pharmacol. 2013;77:466–79. doi:10.1111/bcp.12243.
13. R Development Core Team. R: a language and environment for statistical computing. 2008. R Foundation for Statistical Computing, Vienna, Austria. http://www.R-project.org. Accessed 4 Dec 2013.
14. Beal S, Sheiner LB, Boeckmann A, Bauer RJ. NONMEM user’s guides. 2009. Icon Development Solutions, Ellicott City, MD.
15. Jonsson EN, Karlsson MO. Xpose—an S-PLUS based population pharmacokinetic/pharmacodynamic model building aid for NONMEM. Comput Methods Programs Biomed. 1999;58:51–64.
16. Post TM, Freijer JI, Ploeger BA, Danhof M. Extensions to the visual predictive check to facilitate model performance evaluation. J Pharmacokinet Pharmacodyn. 2008;35:185–202. doi:10.1007/s10928-007-9081-1.
17. Allen A, Bal J, Cheesbrough A, Hamilton M, Kempsford R. Pharmacokinetics and pharmacodynamics of intravenous and inhaled fluticasone furoate in healthy Caucasian and East Asian subjects. Br J Clin Pharmacol. 2014;77:808–20. doi:10.1111/bcp.12263.
18. Allen A. The relationship between fluticasone furoate systemic exposure and cortisol suppression. Clin Pharmakinetics. 2013;52:885–9. doi:10.1007/s40262-013-0078-1.
19. Allen A, Davis A, Hardes K, Tombs L, Kempsford R. Influence of renal and hepatic impairment on the pharmacokinetic and pharmacodynamic properties and tolerability of fluticasone furoate and vilanterol in combination. Clin Ther. 2012;34:2316–32. doi:10.1016/j.clinthera.2012.11.001.
20. Beal SL. Ways to fit a PK model with some data below the quantification limit. J Pharmacokinet Pharmacodyn. 2001;28:481–504.