Mesa 4 [ATS] A phase I, randomised, double blind, placebo ... · [ATS] A phase I, randomised,...
Transcript of Mesa 4 [ATS] A phase I, randomised, double blind, placebo ... · [ATS] A phase I, randomised,...
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[ATS]AphaseI,randomised,doubleblind,placebocontrolled,studytoassessthesafety,tolerabilityandpharmacokine8csofmul8pleinhalesdosesofRpl554administeredby
nebulisertohealthymalesubjetcandstableCOPSpa8ents
SinghD,Abbo>-BannerKH,ReidF,NewmanK
Mesa4
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Introducción
Rpl554esuninhibidordelaPPDE3/4.
Víainhalada.
Acciónbroncodilatadora,an8nflamatoriaybroncoprotectora(Franciosietal.2013).
DosisenascensodelfármacoensanosyEPOC(suspensiónapHneutro).
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Métodos
Varonessanosde18a50años.
EPOCde40a75añosconEPOCmoderadoFEV150-80%(selesre8raronBD,peronoCI.
3gruposEPOCysanos:
1,5mg(n=7)2/24hvs.Placebo(n=3) 6mg(n=7)2/24hvs.Placebo(n=3)
12mg(n=7)2/24hvs.Placebo(n=3)
Seguimientoduranteusodemedicación(7días)yhasta10díasdespués.
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ResultadosBientolerado.
Efectosadversossimilaresaplacebo(adosisaltas:taquicardia).(TA,ECG,Holter).
Farmacociné8ca:vidamedia10-12h.
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Conclusiones
Rpl554bientoleradoadosis8-16vecessuperioresquealasquedemostróefectosBDyan8nflamatoriosinvitro.
EfectobroncodilatadorenpacientesconEPOC.
Administración2vecesaldía.