mesa 4 [ats] a phase i, randomised, double blind, placebo ... · [ats] a phase i, randomised,...

5

[ATS] A phase I, randomised, double blind, placebo controlled, study to assess the safety, tolerability and pharmacokine8cs of mul8ple inhales doses of Rpl554 administered by nebuliser to healthy male subjetc and stable COPS pa8ents Singh D, Abbo>-Banner KH, Reid F, Newman K Mesa 4

Upload: hangoc

Post on 28-Jun-2019

216 views

Category:

Documents

0 download

Report

Download

Embed Size (px):

TRANSCRIPT

Page 1: Mesa 4 [ATS] A phase I, randomised, double blind, placebo ... · [ATS] A phase I, randomised, double blind, placebo controlled, study to assess the safety, tolerability and pharmacokine8cs

[ATS]AphaseI,randomised,doubleblind,placebocontrolled,studytoassessthesafety,tolerabilityandpharmacokine8csofmul8pleinhalesdosesofRpl554administeredby

nebulisertohealthymalesubjetcandstableCOPSpa8ents

SinghD,Abbo>-BannerKH,ReidF,NewmanK

Mesa4

Page 2: Mesa 4 [ATS] A phase I, randomised, double blind, placebo ... · [ATS] A phase I, randomised, double blind, placebo controlled, study to assess the safety, tolerability and pharmacokine8cs

Introducción

Rpl554esuninhibidordelaPPDE3/4.

Víainhalada.

Acciónbroncodilatadora,an8nflamatoriaybroncoprotectora(Franciosietal.2013).

DosisenascensodelfármacoensanosyEPOC(suspensiónapHneutro).

Page 3: Mesa 4 [ATS] A phase I, randomised, double blind, placebo ... · [ATS] A phase I, randomised, double blind, placebo controlled, study to assess the safety, tolerability and pharmacokine8cs

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.

Page 4: Mesa 4 [ATS] A phase I, randomised, double blind, placebo ... · [ATS] A phase I, randomised, double blind, placebo controlled, study to assess the safety, tolerability and pharmacokine8cs

ResultadosBientolerado.

Efectosadversossimilaresaplacebo(adosisaltas:taquicardia).(TA,ECG,Holter).

Farmacociné8ca:vidamedia10-12h.

Page 5: Mesa 4 [ATS] A phase I, randomised, double blind, placebo ... · [ATS] A phase I, randomised, double blind, placebo controlled, study to assess the safety, tolerability and pharmacokine8cs

Conclusiones

Rpl554bientoleradoadosis8-16vecessuperioresquealasquedemostróefectosBDyan8nflamatoriosinvitro.

EfectobroncodilatadorenpacientesconEPOC.

Administración2vecesaldía.

EMT2: EPA for Metastasis Trial 2 A randomised placebo ... · EMT2 Protocol, Version 3.0, 25 May 2017 1 EMT2: EPA for Metastasis Trial 2 A randomised placebo-controlled phase III trial

Baseline characteristics. Patient flow Completed 6 107 Completed 6 108 Perindopril 6 110 Placebo 6 108 Randomised 12 218 Not randomised 1 437 Registered

A Randomised, Double-Blind, Placebo-Controlled ...Study Code D081DC00008 Edition Number Final v2.0 Date 23OCT2017 A Randomised, Double-Blind, Placebo-Controlled, Multicentre Phase

Systematic Review and Meta-Analysis of Randomised, Other ......Systematic Review and Meta-Analysis of Randomised, Other-than-Placebo Controlled, Trials of Individualised Homeopathic

CIBIS II Cardiac Insufficiency Bisoprolol Study Double-blind, placebo-controlled, randomised trial 2,647 patients included (NYHA III + IV) Bisoprolol administered

Imaging Overview DIAS-4. Randomised, double-blind, parallel-group, placebo- controlled phase III study to evaluate the efficacy and safety of desmoteplase

A randomised, placebo-controlled trial of anti–interleukin

Behaviour-change intervention in a multicentre, randomised, placebo

A pilot randomised placebo‐controlled trial of cannabidiol

Comparing the quantity and quality of randomised placebo

researchonline.lshtm.ac.uk et al... · Web viewPhenytoin for neuroprotection in acute optic neuritis: a randomised, placebo-controlled, phase 2 trialneuroprotection in acute optic

spiral.imperial.ac.uk · Web viewEfficacy and safety of alirocumab among patients with and without diabetes: prespecified analysis of a randomised placebo-controlled trial. Kausik

Homeopathic treatment of children with attention- …Homeopathic treatment of children with attention-deficit hyperactivity disorder A randomised, double blind, placebo controlled

A phase III, double-blind, placebo-controlled, randomised

pureportal.coventry.ac.uk · Web viewA double-blind, placebo-controlled, randomised-designed GABA tea study in children diagnosed with Autism Spectrum Conditions: A feasibility

Randomised double blind placebo controlled phase II trial of melatonin … · Randomised double blind placebo controlled phase II trial of melatonin for prevention of delirium in

4-year results from the RAPID-PsA phase 3 randomised ...rmdopen.bmj.com/content/rmdopen/4/1/e000582.full.pdfPsA phase 3 randomised placebo- ... Oscar Irvin-Sellers,8 Majed Khraishi,9

ARIEL3: A P HASE 3, RANDOMISED, DOUBLE-BLIND STUDY OF ... · ARIEL3: A P HASE 3, RANDOMISED, DOUBLE-BLIND STUDY OF RUCAPARIB VS PLACEBO FOLLOWING RESPONSE TO PLATINUM-BASED CHEMOTHERAPY

Systematic review of randomised placebo-controlled trials ... · originally defined by its founder, Samuel ... therapeutic intervention ... argument has reached the point of impasse,

ORIGINAL ARTICLE Randomised, double-blind, placebo ...thorax.bmj.com/content/thoraxjnl/72/1/13.full.pdf · microbial metabolites in the emphysematous lung ... Measurements performed

Systematic review of randomised placebo-controlled trials ... · PDF file1 Homeopathy Research Institute, London, UK 2 Research Department, Swiss Homeopathy Association, Zürich, Switzerland

A protocol for a randomised double-blind placebo

A randomised double-blind placebo-controlled trial investigating the

A randomised placebo-controlled, comparative trial of the

Open Access Protocol Behaviour-change intervention in a … · Behaviour-change intervention in a multicentre, randomised, placebo-controlled COPD study: methodological considerations

Profile Monograph: Pelargonium sidoides Pelargonium ...€¦ · Several other, randomised, double-blind, placebo-controlled studies of special extracts on children and adults have

BMJ Open...Introduction: POISE-2 is an international 2 x 2 factorial randomised controlled trial of low-dose aspirin versus placebo and low-dose clonidine versus placebo in patients

Study protocol for a randomised, double-blind, placebo

“A RANDOMISED, BLINDED, PLACEBO-CONTROLLED, THREE …iumab.club/assets/files/papers/Medicine/2018_Banupriya _homeopat… · Background: The implicit system of Homoeopathy medicine

A Randomised, Double-blind Placebo-controlled Phase IIa

Infliximab for intensification of primary therapy for Kawasaki disease: a phase 3 randomised, double-blind, placebo-controlled trial Journal Club General

Randomised placebo-controlled trials of individualised homeopathic treatment: systematic review and meta-analysis

A Randomised, Double-blind, Placebo controlled, Parallel

A randomised double-blind placebo-controlled trial ......A randomised double-blind placebo-controlled trial investigating the behavioural effects of vitamin, mineral and n-3 fatty

Randomised, Double-Blind, Placebo-Controlled Study of a ......Randomised, Double-Blind, Placebo-Controlled Study of a Single Dose ... (Strepsils Plus lozenge, Reckitt Benckiser, UK)