Effect of severe renal impairment on umeclidinium and umeclidinium/vilanterol pharmacokinetics and safety: a single-blind, nonrandomized study

References

• ChurchABeeraheeMBrooksJMehtaRShahPDose response of umeclidinium administered once or twice daily in patients with COPD: a randomised cross-over studyBMC Pulm Med201414224393134
   PubMed Web of Science ®Google Scholar
• DonohueJFAnzuetoABrooksJMehtaRKalbergCCraterGA randomized, double-blind, dose-ranging study of the novel LAMA GSK573719 in patients with COPDRespir Med201210697097922498110
   PubMed Web of Science ®Google Scholar
• CahnATal-SingerRPouliquenIJSafety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat inhaled doses of umeclidinium in healthy subjects: two randomized studiesClin Drug Investig201333477488
   PubMed Web of Science ®Google Scholar
• DecramerMMaltaisFFeldmanGBronchodilation of umeclidinium, a new long-acting muscarinic antagonist, in COPD patientsRespir Physiol Neurobiol201318539339923026438
   PubMed Web of Science ®Google Scholar
• Tal-SingerRCahnAMehtaRInitial assessment of single and repeat doses of inhaled umeclidinium in patients with chronic obstructive pulmonary disease: two randomised studiesEur J Pharmacol2013701404823276660
   PubMed Web of Science ®Google Scholar
• FeldmanGWalkerRRBrooksJMehtaRCraterG28-Day safety and tolerability of umeclidinium in combination with vilanterol in COPD: a randomized placebo-controlled trialPulm Pharmacol Ther20122546547122955035
   PubMed Web of Science ®Google Scholar
• KelleherDLMehtaRSJean-FrancoisBMSafety, tolerability, pharmacodynamics and pharmacokinetics of umeclidinium and vilanterol alone and in combination: a randomized crossover trialPLoS One20127e5071623284643
   PubMed Web of Science ®Google Scholar
• KelleherDHughesSMehtaRTombsLKellyKChurchAAbsorption, distribution, metabolism, and elimination (ADME) of umeclidinium (UMEC) in healthy adults [abstract]Eur Respir J201240P2153
   Web of Science ®Google Scholar
• KempsfordRAllenABalJRubinDTombsLThe effect of ketoconazole on the pharmacokinetics and pharmacodynamics of inhaled fluticasone furoate and vilanterol trifenatate in healthy subjectsBr J Clin Pharmacol2013751478148723116485
   PubMed Web of Science ®Google Scholar
• MehtaRKelleherDPreeceAHughesSCraterGEffect of vera-pamil on systemic exposure and safety of umeclidinium and vilanterol: a randomized and open-label studyInt J Chron Obstruct Pulmon Dis2013815916723569370
   PubMed Web of Science ®Google Scholar
• Ingelman-SundbergMHuman drug metabolizing cytochrome P450 enzymes: properties and polymorphismsNaunyn Schmiedebergs Arch Pharmacol20043698910414574440
   PubMed Web of Science ®Google Scholar
• ZhouSFXueCCYuXQLiCWangGClinically important drug interactions potentially involving mechanism-based inhibition of cytochrome P450 3A4 and the role of therapeutic drug monitoringTher Drug Monit20072968771018043468
   PubMed Web of Science ®Google Scholar
• US Department of Food and Health Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and ResearchGuidance for Industry, Pharmacokinetics in Patients with Impaired Renal Function – Study Design, Data Analysis, and Impact on Dosing and LabelingRockvilleCenter for Drug Evaluation and Research (CDER); Center for Biologics Evaluation and Research1998 Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072127.pdfAccessed October 10, 2014
   Google Scholar
• AllenADavisAHardesKTombsLKempsfordRInfluence of renal and hepatic impairment on the pharmacokinetic and pharmacodynamic properties and tolerability of fluticasone furoate and vilanterol in combinationClin Ther2012342316233223200625
   PubMed Web of Science ®Google Scholar
• KelleherDHardesKBrealeyNTombsLPreeceAMehtaREffect of severe renal impairment (SRI) on umeclidinium (UMEC) and vilanterol (VI) pharmacokinetics (PK) [abstract]Eur Respir J2013424148
   Web of Science ®Google Scholar
• WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human SubjectsAdopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964 and amended (latest) by the 59th WMA General Assembly, Seoul, Korea, October 2008 [webpage on the Internet]Ferney-VoltaireWMA The World Medical Association [updated Oct 2008]. Available from: http://www.wma.net/en/30publications/10policies/b3/index.htmlAccessed October 10, 2014
   Google Scholar
• International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human UseICH Harmonised Tripartite Guideline. Guideline for Good Clinical Practice E6(R1)International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdfAccessed October 10, 2014
   Google Scholar
• HarrellAWSiedererSKBalJMetabolism and disposition of vilanterol, a long-acting β(2)-adrenoreceptor agonist for inhalation use in humansDrug Metab Dispos2013418910023043183
   PubMed Web of Science ®Google Scholar
• CahnAMehtaRPreeceABlowersJDonaldASafety, tolerability and pharmacokinetics and pharmacodynamics of inhaled once-daily umeclidinium in healthy adults deficient in CYP2D6 activity: a double-blind, randomized clinical trialClin Drug Invest201333653664
   PubMed Web of Science ®Google Scholar
• CoyleDWManagement of Chronic Kidney Disease Comorbidities. Medscape education Available from: http://www.medscape.org/viewarticle/736181Accessed October 10, 2014
   Google Scholar
• MehtaRHardesKKelleherDPreeceATombsLBrealeyNEffects of moderate hepatic impairment on the pharmacokinetic properties and tolerability of umeclidinium and vilanterol in inhalational umeclidinium monotherapy and umeclindinum/vilanterol combination therapy: an open-label, non-randomised studyClin Ther2014361016102724947493
   PubMed Web of Science ®Google Scholar
• HarrellAWSiedererSKBalJMetabolism and disposition of vilanterol, a long-acting β(2) adrenoreceptor agonist, for inhalation use in humansDrug Metab Dispos2013418910023043183
   PubMed Web of Science ®Google Scholar
• MehtaRHardesKCahnASafety, tolerability and pharmacokinetics (PK) of repeated doses of GSK573719 inhalation powder, a new long-acting muscarinic antagonist, in healthy adults [abstract]Eur Respir J201138Suppl 553972
   Google Scholar
• GoyalNBeeraheeMKalbergCChurchAKilbrideSMehtaRPopulation pharmacokinetics of inhaled umeclidinium and vilanterol in patients with chronic obstructive pulmonary diseaseClin Pharmacokinet20145363764824756395
   PubMed Web of Science ®Google Scholar
• Spiriva^® HandiHaler^® (tiotropium bromide inhalation powder) capsules for respiratory inhalation [prescribing information]RidgefieldBoehringer Ingelheim Pharmaceuticals, Inc2014 Available from: http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/Spiriva/Spiriva.pdfAccessed October 10, 2014
   Google Scholar
• European Medicines AgencyAnnex I: Summary of Product Characteristics: Glycopyrronium BromideLondonEuropean Medicines Agency2012 Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002430/WC500133769.pdfAccessed October 10, 2014
   Google Scholar
• Tudorza™ Pressair™ (aclidinium bromide inhalation powder) [prescribing information update]St LouisForest Laboratories, Inc2014 Available from: http://www.frx.com/pi/tudorza_pi.pdfAccessed October 10, 2014
   Google Scholar
• SchmidKPascualSGilEGOrtizSJansatJMPharmacokinetics and safety of aclidinium bromide, a muscarinic antagonist, in adults with normal or impaired renal function: A phase I, open-label, single-dose clinical trialClin Ther2010321798181221194604
   PubMed Web of Science ®Google Scholar