Model-based evaluation of pulmonary pharmacokinetics in asthmatic and COPD patients after oral olodaterol inhalation

British Journal of Clinical Pharmacology

Volumn , Issue , 2016, Pages 739-753

  Borghardt, Jens Markus ^a,b   Weber, Benjamin ^b   Staab, Alexander ^b   Kunz, Christina ^b   Kloft, Charlotte ^a  

^a FREIE UNIVERSITÄT BERLIN   (Germany)

^b BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

Author keywords

asthma; COPD; olodaterol inhalation; pharmacometrics; population pharmacokinetics; pulmonary absorption

Indexed keywords

OLODATEROL;

ABSORPTION HALF-LIFE; ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; ASTHMA; CHRONIC OBSTRUCTIVE LUNG DISEASE; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG EXCRETION; DRUG URINE LEVEL; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; PRIORITY JOURNAL; SIMULATION; SOFT MIST INHALER;

EID: 84982950440     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/bcp.12999     Document Type: Article

References (47)

1. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease, 2015. Available at http://www.goldcopd.it/materiale/2015/GOLD_Report_2015.pdf
2. Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention, 2016. http://ginasthma.org/2016-gina-report-global-strategy-for-asthma-management-and-prevention/
3. Borgström L, Derom E, Ståhl E, Wåhlin-Boll E, Pauwels R. The inhalation device influences lung deposition and bronchodilating effect of terbutaline. Am J Respir Crit Care Med 1996; 153: 1636–40.
4. Borgström L, Bengtsson T, Derom E, Pauwels R. Variability in lung deposition of inhaled drug, within and between asthmatic patients, with a pMDI and a dry powder inhaler, Turbuhaler®. Int J Pharm 2000; 193: 227–30.
5. Parra-Guillen Z, Weber B, Sharma A, Freijer J, Retlich S, Borghardt JM, et al. Population pharmacokinetic analysis of tiotropium in healthy volunteers after intravenous administration and inhalation. J Pharmacokinet Pharmacodyn 2014; 41: S54.
6. Borghardt JM, Weber B, Staab A, Kunz C, Formella S, Kloft C. Investigating pulmonary and systemic pharmacokinetics of inhaled olodaterol in healthy volunteers using a population pharmacokinetic approach. Br J Clin Pharmacol 2016; 81: 538–52.
7. Casarosa P, Kollak I, Kiechle T, Ostermann A, Schnapp A, Kiesling R, et al. Functional and biochemical rationales for the 24-hour-long duration of action of olodaterol. J Pharmacol Exp Ther 2011; 337: 600–9.
8. Darquenne C. Aerosol deposition in health and disease. J Aerosol Med Pulm Drug Deliv 2012; 25: 140–7.
9. Barnes PJ, Drazen J, Rennard SI, Thomson NC, eds, eds.Asthma and COPD: Basic Mechanisms and Clinical Management, 2nd edn. Amsterdam: Elsevier, 2009.
10. Brutsche MH, Brutsche IC, Munavvar M, Langley SJ, Masterson CM, Daley-Yates P, et al. Comparison of pharmacokinetic and systemic effects of inhaled fluticasone proprionate in patients with asthma and healthy volunteers: a randomised crossover study. Lancet 2000; 356: 556–61.
11. Hallett C. Corticosteroid treatment of asthma: now at the crossroads. Respir Med 1999; 93: 292–4.
12. Bartels C, Looby M, Sechaud R, Kaiser G. Determination of the pharmacokinetics of glycopyrronium in the lung using a population pharmacokinetic modelling approach. Br J Clin Pharmacol 2013; 76: 868–79.
13. Dershwitz M, Walsh JL, Morishige RJ, Connors PM, Rubsamen RM, Shafer SL, et al. Pharmacokinetics and pharmacodynamics of inhaled versus intravenous morphine in healthy volunteers. Anesthesiology 2000; 93: 619–28.
14. Krishnaswami S, Hochhaus G, Möllmann H, Barth J, Derendorf H. Interpretation of absorption rate data for inhaled fluticasone propionate obtained in compartmental pharmacokinetic modeling. Int J Clin Pharmacol Ther 2005; 43: 117–22.
15. Bonate PL. Pharmacokinetic-Pharmacodynamic Modeling and Simulation, 2nd edn. New York: Springer Science and Business Media, 2011.
16. Gastonguay MR. Full Covariate Models as an Alternative to Methods Relying on Statistical Significance for Inferences about Covariate Effects: A Review of Methodology and 42 Case Studies. PAGE. Abstracts of the Annual Meeting of the Population Approach Group in Europe, Abstr 2229, Athen, Greece.
17. Keizer RJ, Karlsson MO, Hooker A. Modeling and simulation workbench for NONMEM: Tutorial on Pirana, PsN, and Xpose. CPT Pharmacometrics Syst Pharmacol 2013; 2:.e50
18. R Core Team. R: A Language and Environment for Statistical Computing. Vienna: R Foundation for Statistical Computing, 2014.
19. Soetaert K, Petzoldt T, Setzer RW. Solving differential equations in R: Package deSolve. J Stat Software 2010; 33: 1–25.
20. Neale MG, Brown K, Foulds RA, Lal S, Morris DA, Thomas D. The pharmacokinetics of nedocromil sodium, a new drug for the treatment of reversible obstructive airways disease, in human volunteers and patients with reversible obstructive airways disease. Br J Clin Pharmacol 1987; 24: 493–501.
21. Edsbacker S, Wollmer P, Selroos O, Borgstrom L, Olsson B, Ingelf J. Do airway clearance mechanisms influence the local and systemic effects of inhaled corticosteroids? Pulm Pharmacol Ther 2008; 21: 247–58.
22. Smaldone GC, Perry RJ, Bennett WD, Messina MS, Zwang J, Ilowite J. Interpretation of “24 hour lung retention” in studies of mucociliary clearance. J Aerosol Med 1988; 1: 11–20.
23. Foster WM, Langenback E, Bergofsky EH. Measurement of tracheal and bronchial mucus velocities in man: relation to lung clearance. J Appl Physiol Respir Environ Exerc Physiol 1980; 48: 965–71.
24. Usmani OS, Barnes PJ. Assessing and treating small airways disease in asthma and chronic obstructive pulmonary disease. Ann Med 2012; 44: 146–56.
25. Usmani OS, Biddiscombe MF, Barnes PJ. Regional lung deposition and bronchodilator response as a function of β2-agonist particle size. Am J Respir Crit Care Med 2005; 172: 1497–504.
26. Aoshiba K, Nagai A. Differences in airway remodeling between asthma and chronic obstructive pulmonary disease. Clin Rev Allergy Immunol 2004; 27: 35–43.
27. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976; 16: 31–41.
28. Kunz C, Luedtke D, Unseld A, Hamilton A, Halabi A, Wein M, et al. Pharmacokinetics and safety of olodaterol administered with the Respimat Soft Mist inhaler in subjects with impaired hepatic or renal function. Int J Chron Obstruct Pulmon Dis 2016; 11: 585–95.
29. Grgic B, Finlay WH, Burnell PKP, Heenan AF. In vitro intersubject and intrasubject deposition measurements in realistic mouth-throat geometries. Aerosol Sci 2004; 35: 1025–40.
30. Asgharian B, Price OT, Hofmann W. Prediction of particle deposition in the human lung using realistic models of lung ventilation. Aerosol Sci 2006; 37: 1209–21.
31. Brand P, Hederer B, Austen G, Dewberry H, Meyer T. Higher lung deposition with Respimat®Soft MistTMinhaler than HFA-MDI in COPD patients with poor technique. Int J COPD 2008; 3: 763–70.
32. Bäckström E, Lundqvist A, Boger E, Svanberg P, Ewing P, Hammarlund-Udenaes M, et al. Development of a novel lung slice methodology for profiling of inhaled compounds. J Pharm Sci 2016; 105: 838–45.
33. Bjermer L, Rosenborg J, Bengtsson T, Lotvall J. Comparison of the bronchodilator and systemic effects of AZD3199, an inhaled ultra-long-acting beta(2)-adrenoceptor agonist, with formoterol in patients with asthma. Ther Adv Respir Dis 2013; 7: 264–71.
34. Stocks MJ, Alcaraz L, Bailey A, Bonnert R, Cadogan E, Christie J, et al. Discovery of AZD3199, an inhaled ultralong acting beta2 receptor agonist with rapid onset of action. ACS Med Chem Lett 2014; 5: 416–21.
35. Daley-Yates PT. Inhaled corticosteroids: potency, dose equivalence and therapeutic index. Br J Clin Pharmacol 2015; 80: 372–80.
36. Cook CD, Helliesen PJ, Agathon S. Relation between mechanics of respiration, lung size and body size from birth to young adulthood. J Appl Physiol 1958; 13: 349–52.
37. Perrie Y, Badhan RK, Kirby DJ, Lowry D, Mohammed AR, Ouyang D. The impact of ageing on the barriers to drug delivery. J Control Release 2012; 161: 389–98.
38. DeMeo DL, Weiss ST. Epidemiology. In: Asthma and COPD: Basic Mechanisms and Clinical Management, 2nd edn, eds Barnes PJ, Rennard SI, Drazen JM, Thomson NC. Amsterdam: Elsevier, 2009; 9–22.
39. Matsushima S, Matthews I, Woessner R, Pinault G, Hara H, Wilkins J, et al. Systemic pharmacokinetics of indacaterol, an inhaled once-daily long-acting beta2-agonist, in different ethnic populations. Int J Clin Pharmacol Ther 2012; 50: 545–56.
40. Shimada S, Vaidya S, Khindri S, Tashiro N, Cheng Y, Hara H, et al. Pharmacokinetics of QMF149 in Japanese versus Caucasian subjects: an open-label, randomized phase I study. Int J Clin Pharmacol Ther 2015; 53: 398–407.
41. Kim CS, Hu SC. Regional deposition of inhaled particles in human comparison between men and women. J Appl Physiol 1998; 84: 1834–44.
42. 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.
43. James AL, Wenzel S. Clinical relevance of airway remodelling in airway diseases. Eur Respir J 2007; 30: 134–55.
44. Holgate ST. Airway remodeling. In: Asthma and COPD: Basic Mechanisms and Clinical Management, 2nd edn, eds Barnes PJ, Drazen JM, Rennard SI, Thomson NC. Amsterdam: Elsevier, 2009; 83–97.
45. Paredi P, Barnes PJ. The airway vasculature: recent advances and clinical implications. Thorax 2009; 64: 444–50.
46. Shaykhiev R, Otaki F, Bonsu P, Dang DT, Teater M, Strulovici-Barel Y, et al. Cigarette smoking reprograms apical junctional complex molecular architecture in the human airway epithelium in vivo. Cell Mol Life Sci 2011; 68: 877–92.
47. Sakagami M. Insulin disposition in the lung following oral inhalation in humans: a meta-analysis of its pharmacokinetics. Clin Pharmacokinet 2004; 43: 539–52.