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Review

Role of nebulized glycopyrrolate in the treatment of chronic obstructive pulmonary disease

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Pages 3257-3271 | Published online: 15 Nov 2017

References

  • Global Initiative for Chronic Obstructive Lung Disease (GOLD) [homepage on the Internet]Global Strategy for Diagnosis, Management, and Prevention of COPD2016 Available from: http://goldcopd.org/Accessed August 25, 2017
  • MathersCDLoncarDProjections of global mortality and burden of disease from 2002 to 2030PLoS Med2006311 e44217132052
  • McDonoughJEYuanRSuzukiMSmall-airway obstruction and emphysema in chronic obstructive pulmonary diseaseN Engl J Med201136517 1567 157522029978
  • SeniorRAtkinsonJChronic obstructive pulmonary disease: epidemiology pathophysiology, and pathogenesisAlfred FishmanMFishman’s Pulmonary Diseases and DisordersI4th edNew York, NYMcGraw Hill Medical2008 707 728
  • O’DonnellDELavenezianaPPhysiology and consequences of lung hyperinflation in COPDEur Respir Rev200615100 61 67
  • PecchiariMRadovanovicDSantusPD’AngeloEAirway occlusion assessed by single breath N2 test and lung P-V curve in healthy subjects and COPD patientsRespir Physiol Neurobiol2016234 60 6827612586
  • SantusPRadovanovicDDi MarcoSEffect of indacaterol on lung deflation improves cardiac performance in hyperinflated COPD patients: an interventional, randomized, double-blind clinical trialInt J Chron Obstruct Pulmon Dis201510 1917 192326392766
  • PecchiariMMSantusPRadovanovicDD’AngeloEGThe acute effects of long acting bronchodilators on small airways detected in COPD patients by single breath N2 test and lung P-V curveJ Appl Physiol Epub2017
  • O’DonnellDEFlugeTGerkenFEffects of tiotropium on lung hyperinflation, dyspnoea and exercise tolerance in COPDEur Respir J2004236 832 84015218994
  • ScichiloneNBenfanteABocchinoMWhich factors affect the choice of the inhaler in chronic obstructive respiratory diseases?Pulm Pharmacol Ther201531 63 6725724817
  • DolovichMBAhrensRCHessDRAmerican College of Chest PhysiciansAmerican College of Asthma, Allergy, and ImmunologyDevice selection and outcomes of aerosol therapy: evidence-based guidelines: American College of Chest Physicians/American College of Asthma, Allergy, and ImmunologyChest20051271 335 37115654001
  • BartaSKCrawfordARobertsCMSurvey of patients’views of domiciliary nebulizer treatment for chronic lung diseaseRespir Med2002966 375 38112117035
  • SantusPRadovanovicDPaggiaroPWhy use long acting bronchodilators in chronic obstructive lung diseases? An extensive review on formoterol and salmeterolEur J Intern Med2015266 379 38426049917
  • HickeyAJPharmaceutical Inhalation Aerosol Technology2nd edNew YorkMarcel Dekker2004
  • SabatéEAdherence to Long-Term Therapies: Evidence for ActionGenevaWorld Health Organization 2003 Available from: http://www.who.int/chp/knowledge/publications/adherence_full_report.pdf?ua=1Accessed August 18, 2017
  • SulaimanICushenBGreeneGObjective assessment of adherence to inhalers by patients with chronic obstructive pulmonary diseaseAm J Respir Crit Care Med201719510 140728504606
  • RauJLDeterminants of patient adherence to an aerosol regimenRespir Care20055010 1346 135916185370
  • FerroniEBelleudiVCasciniSOUTPUL Study GroupRole of tiotropium in reducing exacerbations of chronic obstructive pulmonary disease when combined with long-acting β2-agonists and inhaled corticosteroids: the OUTPUL studyPharmacoepidemiol Drug Saf20162511 1295 130427396695
  • RamFSBrocklebankDMMuersMWrightJJonesPWPressurised metered-dose inhalers versus all other hand-held inhalers devices to deliver bronchodilators for chronic obstructive pulmonary diseaseCochrane Database Syst Rev20021 CD002170
  • TurnerMOPatelAGinsburgSFitzGeraldJMBronchodilator delivery in acute airflow obstruction. A meta-analysisArch Intern Med199715715 1736 17449250235
  • DhandRDolovichMChippsBMyersTRRestrepoRFarrarJRThe role of nebulized therapy in the management of COPD: evidence and recommendationsCOPD201291 58 7222292598
  • WedzichaJADecramerMFickerJHAnalysis of chronic obstructive pulmonary disease exacerbations with the dual bronchodilator QVA149 compared with glycopyrronium and tiotropium (SPARK): a randomised, double-blind, parallel-group studyLancet Respir Med201313 199 20924429126
  • SestiniPCappielloVAlianiMAssociazione Italiana Pneumologi Ospedalieri Educational GroupPrescription bias and factors associated with improper use of inhalersJ Aerosol Med2006192 127 13616796537
  • BlasiFCanonicaGWCentanniSGenuair® usability test: results of a national public survey of the elderlyCOPD2016133 367 37126645660
  • LavoriniFManniniCChelliniEFontanaGAOptimising inhaled pharmacotherapy for elderly patients with chronic obstructive pulmonary disease: the importance of delivery devicesDrugs Aging2016337 461 47327216613
  • CromptonGKBarnesPJBroederMAerosol Drug Management Improvement TeamThe need to improve inhalation technique in Europe: a report from the Aerosol Drug Management Improvement TeamRespir Med20061009 1479 149416495040
  • PriceDBosnic-AnticevicSBriggsAInhaler competence in asthma: common errors, barriers to use and recommended solutionsRespir Med20131071 37 4623098685
  • AndersonPUse of Respimat® Soft Mist™ Inhaler in COPD patientsInt J Chron Obstruct Pulmon Dis200613 251 25918046862
  • RauJLPractical problems with aerosol therapy in COPDRespir Care2006512 158 17216441960
  • BoeJDennisJHO’DriscollBREuropean Respiratory Society Task Force on the use of nebulizersEuropean Respiratory Society Guidelines on the use of nebulizersEur Respir J2001181 228 24211510796
  • SharafkhanehAWolfRAGoodnightSHananiaNAMakeBJTashkinDPPerceptions and attitudes toward the use of nebulized therapy for COPD: patient and caregiver perspectivesCOPD2013104 482 49223875742
  • VogelmeierCHedererBGlaabTPOET-COPD InvestigatorsTiotropium versus salmeterol for the prevention of exacerbations of COPDN Engl J Med201136412 1093 110321428765
  • DecramerMChapmanKDahlRINVIGORATE InvestigatorsOnce-daily indacaterol versus tiotropium for patients with severe chronic obstructive pulmonary disease (INVIGORATE): a randomised, blinded, parallel-group studyLancet Respir Med201317 524 53324461613
  • BuhlRBanerjiDProfile of glycopyrronium for once-daily treatment of moderate-to-severe COPDInt J Chron Obstruct Pulmon Dis20127 729 74123118536
  • KerwinEHébertJGallagherNEfficacy and safety of NVA237 versus placebo and tiotropium in patients with COPD: the GLOW2 studyEur Respir J2012405 1106 111423060624
  • BeehKMSinghDDi ScalaLDrollmannAOnce-daily NVA237 improves exercise tolerance from the first dose in patients with COPD: the GLOW3 trialInt J Chron Obstruct Pulmon Dis20127 503 51322973092
  • RadovanovicDManteroMSferrazza PapaGFFormoterol fumarate + glycopyrrolate for the treatment of chronic obstructive pulmonary diseaseExpert Rev Respir Med20161010 1045 105527552524
  • VestboJPapiACorradiMSingle inhaler extrafine triple therapy versus long-acting muscarinic antagonist therapy for chronic obstructive pulmonary disease (TRINITY): a double-blind, parallel group, randomised controlled trialLancet201738910082 1919 192928385353
  • JohnsonBESurattPMGalTJWilhoitSCEffect of inhaled glycopyrrolate and atropine in asthma. Precipitated by exercise and cold air inhalationChest1984853 325 3286697786
  • CydulkaRKEmermanCLEffects of combined treatment with glycopyrrolate and albuterol in acute exacerbation of chronic obstructive pulmonary diseaseAnn Emerg Med1995254 470 4737710150
  • LeakerBRBarnesPJJonesCRTutuncuASinghDEfficacy and safety of nebulized glycopyrrolate for administration using a high efficiency nebulizer in patients with chronic obstructive pulmonary diseaseBr J Clin Pharmacol2015793 492 50025243340
  • Sunovion Respiratory Development IncStudy to investigate the dose response, safety and efficacy of nebulized ep-101(sun101) in patients with chronic obstructive pulmonary disease (COPD): GOLDEN-1 Study Available from: https://clinicaltrials.gov/ct2/show/NCT01426009?term=NCT01426009. NLM identifier: NCT01426009Accessed July 15, 2017
  • Sunovion Respiratory Development IncA study of the efficacy and safety of EP-101 (SUN101) in subjects with moderate to severe chronic obstructive pulmonary disease (GOLDEN-2) Available from: https://clinicaltrials.gov/ct2/show/NCT01706536. NLM identifier: NCT01706536Accessed July 15, 2017
  • Sunovion Respiratory Development IncEfficacy and safety trial of 12 weeks of treatment with nebulized SUN-101 in patients with COPD (GOLDEN-3) Available from: https://clinicaltrials.gov/ct2/show/NCT02347761. NLM identifier: NCT02347761Accessed July 15, 2017
  • Sunovion Respiratory Development IncEfficacy and safety trial of 12 weeks of treatment with nebulized SUN-101 in patients with COPD (GOLDEN-4) Available from: https://clinicaltrials.gov/ct2/show/NCT02347774. NLM identifier: NCT02347774Accessed July 15, 2017
  • Sunovion Respiratory Development IncA long-term safety trial of treatment with nebulized SUN-101 in patients with COPD (GOLDEN-5) Available from: https://clinicaltrials.gov/ct2/show/NCT02276222. NLM identifier: NCT02276222Accessed July 15, 2017
  • Sunovion Respiratory Development IncA dose-range finding study of SUN-101 in subjects with moderate to severe COPD (GOLDEN 6) Available from: https://clinicaltrials.gov/ct2/show/NCT02038829. NLM identifier: NCT02038829Accessed July 15, 2017
  • Sunovion Respiratory Development IncStudy to determine the amount of glycopyrrolate absorbed in the lungs after taking the medicine with a eFlow nebulizer and Seebri® Breezhaler® with and without activated charcoal in subjects with moderate to severe chronic obstructive pulmonary disease (COPD) (GOLDEN7) Available from: https://clinicaltrials.gov/ct2/show/NCT02512302. NLM identifier: NCT02512302Accessed July 15, 2017
  • BerlinskiAAssessing new technologies in aerosol medicine: strengths and limitationsRespir Care2015606 833 84726070578
  • LenneyWEdenboroughFKhoPKovarikJMLung deposition of inhaled tobramycin with eFlow rapid/LC Plus jet nebulizer in healthy and cystic fibrosis subjectsJ Cyst Fibros2011101 9 1420884302
  • AriAJet, ultrasonic, and mesh nebulizers: an evaluation of nebulizers for better clinical outcomesEurasian J Pulmonol2014161 1 7
  • HeyderJSvartengrenMUBasic principles of particle behaviour in the human respiratory tractBisgaardHO’CallaghanCSmaldoneGCDrug Delivery to the LungNew York, NYMarcel Dekker2002 21 45
  • de BoerAHGjaltemaDHagedoornPFrijlinkHWCan “extrafine” dry powder inhalers improve lung deposition?Eur J Pharm Biopharm201596 143 15126220014
  • PhamSFergusonGTKerwinEMGoodinTWheelerABauerAIn-vitro characterization of the Eflow® Closed-System (eFlow® Cs) nebulizer with glycopyrrolate inhalation solution (SUN-101)Am J Respir Crit Care Med2017195 A5472
  • MerkusPJvan Essen-ZandvlietEEParlevlietEChanges of nebulizer output over the yearsEur Respir J199254 488 4911563507
  • AlvineGFRodgersPFitzsimmonsKMAhrensRCDisposable jet nebulizers: how reliable are they?Chest19921012 316 3191735247
  • O’CallaghanCBarryPWThe science of nebulised drug deliveryThorax199752suppl 2 S31 S449155849
  • BanfiPTicozziNLaxAGuidugliGANicoliniASilaniVA review of options for treating sialorrhea in amyotrophic lateral sclerosisRespir Care2015603 446 45425228780
  • BlissitKTTilleryELathamCPacheco-PerezJGlycopyrrolate for treatment of clozapine-induced sialorrhea in adultsAm J Health Syst Pharm20147115 1282 128725027535
  • Robinul® (Glycopyrrolate) oral tablets [prescribing information]Atlanta, GAShionogi Pharma2010
  • National Center for Biotechnology Information [webpage on the Internet]PubChem Compound Database; CID=116932017 Available from: https://pubchem.ncbi.nlm.nih.gov/compound/11693Accessed July 25, 2017
  • CarterNJInhaled glycopyrronium bromide. A review of its use in patients with moderate to severe chronic obstructive pulmonary diseaseDrugs2013737 741 75323677802
  • Bevespi Aerosphere™ [prescribing information]WilmingtonAstra-Zeneca Pharmaceuticals LP2017
  • Ema.europa.euSeebri® Breezhaler® (GB): European Medicines Agency Assessment ReportLondon, UKEuropean Medicines Agency2012 Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002430/WC500133771.pdfAccessed Jul 5, 2017
  • CazzolaMPageCPCalzettaLMateraMGPharmacology and therapeutics of bronchodilatorsPharmacol Rev2012643 450 50422611179
  • UlrikCSOnce-daily glycopyrronium bromide, a long-acting muscarinic antagonist, for chronic obstructive pulmonary disease: a systematic review of clinical benefitInt J Chron Obstruct Pulmon Dis20127 673 67823055716
  • HaddadEBPatelHKeelingJEYacoubMHBarnesPJBelvisiMGPharmacological characterization of the muscarinic receptor antagonist, glycopyrrolate, in human and guinea-pig airwaysBr J Pharmacol19991272 413 42010385241
  • RestrepoRDUse of inhaled anticholinergic agents in obstructive airway diseaseRespir Care2007527 833 85117594728
  • MoultonBCFryerADMuscarinic receptor antagonists, from folklore to pharmacology; finding drugs that actually work in asthma and COPDBr J Pharmacol20111631 44 5221198547
  • SykesDADowlingMRLeighton-DaviesJThe influence of receptor kinetics on the onset and duration of action and the therapeutic index of NVA237 and tiotropiumJ Pharmacol Exp Ther20123432 520 52822854200
  • HanselTTBarnesPJTiotropium bromide: a novel once-daily anti-cholinergic bronchodilator for the treatment of COPDDrugs Today (Barc)2002389 585 60012582447
  • BuelsKSFryerADMuscarinic receptor antagonists: effects on pulmonary functionHandb Exp Pharmacol2012208 317 341
  • HanselTTNeighbourHErinEMGlycopyrrolate causes prolonged bronchoprotection and bronchodilation in patients with asthmaChest20051284 1974 197916236844
  • RadovanovicDSantusPBlasiFManteroMThe evidence on tiotropium bromide in asthma: from the rationale to the bedsideMultidiscip Respir Med201712 1228484598
  • VerkindreCFukuchiYFlémaleASustained 24-h efficacy of NVA237, a once-daily long-acting muscarinic antagonist, in COPD patientsRespir Med201010410 1482 148920541381
  • SantusPRadovanovicDDi MarcoFRaccanelliRValentiVCentanniSFaster reduction in hyperinflation and improvement in lung ventilation inhomogeneity promoted by aclidinium compared to glycopyrronium in severe stable COPD patients. A randomized crossover studyPulm Pharmacol Ther201535 42 4926549785
  • VillettiGBergamaschiMBassaniFPharmacological assessment of the duration of action of glycopyrrolate vs tiotropium and ipratropium in guinea-pig and human airwaysBr J Pharmacol20061483 291 29816565730
  • RoglianiPCalzettaLOraJPharmacological assessment of the onset of action of aclidinium and glycopyrronium versus tiotropium in COPD patients and human isolated bronchiEur J Pharmacol2015761 383 39025952728
  • Ema.europa.eu [webpage on the Internet]London, UKEuropean Medicines Agency2017 Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002430/human_med_001580.jsp&mid=WC0b01ac058001d124Accessed Oct 16, 2017
  • Pmda.go.jpJCN 301000500740Tokyo, JapanPharmaceuticals and Medical Devices Agency2012 Available from: http://www.pmda.go.jp/files/000153897.pdfAccessed Oct 15, 2017
  • Accessdata.fda.gov [webpage on the Internet]AdministrationSilver Spring, MDU.S. Food and Drug Administration2015 Available from: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207923Accessed Oct 15, 2017
  • Ema.europa.euTrimbow ® Summary of Opinion (Initial Authorisation)London, UKEuropean Medicines Agency2017 Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/004257/WC500228080.pdfAccessed Oct 11, 2017
  • Sunovion.usMarlborough, MASunovion Press Release2017 Available from: http://www.sunovion.us/featured-news/press-releases/20170526.pdfAccessed on Oct 10, 2017
  • FogartyCKerwinEDunnKSinghDTutuncuAThe GOLDEN-1 study: safety and bronchodilatory effects of nebulized glycopyrrolate (EP-101) using high efficiency nebulizer in patients with COPDEur Respir J201240 2194
  • TashkinDPA review of nebulized drug delivery in COPDInt J Chron Obstruct Pulmon Dis201611 2585 259627799757
  • DonohueJFGoodinTTosielloRWheelerADose selection for SUN-101/eFlow® phase 3 clinical studies: results from GOLDEN (Glycopyrrolate for obstructive lung disease via electronic nebulizer) phase 2 dose-finding studiesAm J Respir Crit Care Med2017195 A3591
  • FergusonGTKerwinEMDonohueJFOzol-GodfreyAGanapathyVHealth-related quality of life (HRQoL) in moderate-to-very severe chronic obstructive pulmonary disease (COPD) patients treated with SUN-101 (glycopyrrolate/eFlow®): findings from the phase 3 GOLDEN studiesAm J Respir Crit Care Med2017195 A1402
  • KerwinEMDonohueJFGoodinTEfficacy and safety of glycopyrrolate/eFlow® (nebulized glycopyrrolate) in moderate-to-very-severe COPD: Results from the glycopyrrolate for obstructive lung disease via electronic nebulizer (GOLDEN) 3 and 4 randomized controlled trialsRespir Res2017181 828061907
  • FergusonGTGoodinTTosielloRWheelerAKerwinEMLong-term safety of SUN-101/eFlow® in moderate-to-very-severe COPD: results from the glycopyrrolate for obstructive lung disease via electronic nebulizer (GOLDEN) 5 studyAm J Respir Crit Care Med2017195 A3588
  • AliFYLeakerBRNicholsonGCSinghDBarnesPJA five-way crossover study to compare systemic absorption and bronchodilator effect of glycopyrrolate after a single dose delivered by nebulizer (SUN-101) or a dry powder inhaler (seebri) and in patients with COPD (GOLDEN-7)Am J Respir Crit Care Med2017195 A3604
  • KerwinEMFogartyCDunnKSinghDTutuncuACardiovascular safety of nebulized glycopyrrolate (SUN-101) compared with tiotropium, ipratropium and placebo in patients with COPDAm J Respir Crit Care Med2013187 A1483
  • DonohueJFFergusonGTKerwinEMOzol-GodfreyAGanapathyVImprovement in respiratory symptoms in moderate-to-very severe chronic obstructive pulmonary disease patients treated with SUN-101 (glycopyrrolate/eFlow®) – patient-reported outcomes from the phase 3 GOLDEN studiesAm J Respir Crit Care Med2017195 A5738
  • KerwinEMDonohueJFFergusonGTOzol-GodfreyAGanapathyVPatient device satisfaction with eFlow closed system nebulizer: results from the GOLDEN-5 study in patients with moderate-to-very-severe chronic obstructive pulmonary disease (COPD)Am J Respir Crit Care Med2017195 A1416