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A phase III randomised controlled trial of single-dose triple therapy in COPD: the IMPACT protocol.
Pascoe, Steven J; Lipson, David A; Locantore, Nicholas; Barnacle, Helen; Brealey, Noushin; Mohindra, Rajat; Dransfield, Mark T; Pavord, Ian; Barnes, Neil.
Afiliación
  • Pascoe SJ; Respiratory Research and Development, GSK, King of Prussia, PA, USA steven.j.pascoe@gsk.com.
  • Lipson DA; Respiratory Research and Development, GSK, King of Prussia, PA, USA Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
  • Locantore N; Respiratory Research and Development, GSK, King of Prussia, PA, USA.
  • Barnacle H; Respiratory Medicines Development Centre, GSK, Brentford, UK.
  • Brealey N; Respiratory Medicines Development Centre, GSK, Brentford, UK.
  • Mohindra R; Respiratory Medicines Development Centre, GSK, Brentford, UK.
  • Dransfield MT; UAB Lung Health Center, University of Alabama at Birmingham, Birmingham, AL, USA.
  • Pavord I; Respiratory Medicine Unit, Nuffield Department of Clinical Medicine, University of Oxford, Old Road Campus, Oxford, UK.
  • Barnes N; Respiratory Medicines Development Centre, GSK, Brentford, UK William Harvey Institute, Barts & The London School of Medicine and Dentistry, London, UK.
Eur Respir J ; 48(2): 320-30, 2016 08.
Article en En | MEDLINE | ID: mdl-27418551
Patients with symptomatic advanced chronic obstructive pulmonary disease (COPD) who experience recurrent exacerbations are particularly at risk of poor outcomes and present a significant burden on healthcare systems. The relative merits of treating with different inhaled combination therapies e.g. inhaled corticosteroids (ICS)/long-acting ß2-agonist (LABA), LABA/long-acting muscarinic antagonists (LAMA), ICS/LABA/LAMA, in this patient group are poorly understood, as is reflected in current guidelines. The InforMing the PAthway of COPD Treatment (IMPACT) study will evaluate the efficacy and safety of fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI) versus FF/VI or UMEC/VI over a 52-week treatment period. The study has been designed with a focus on understanding the comparative merits of each treatment modality in different phenotypes/endotypes.This is a phase III, randomised, double-blind, three-arm, parallel-group, global multicentre study comparing the rate of moderate and severe exacerbations between FF/UMEC/VI and FF/VI or UMEC/VI over a 52-week treatment period. The study aims to recruit 10 000 patients from approximately 1070 centres. Eligible patients are aged ≥40 years, with symptomatic advanced COPD (Global initiative for chronic Obstructive Lung Disease (GOLD) group D) and an exacerbation in the previous 12 months.The first patients were recruited to the IMPACT study (ClinicalTrials.gov: NCT02164513) in June 2014 and the anticipated completion date is July 2017.
Asunto(s)

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Quinuclidinas / Alcoholes Bencílicos / Clorobencenos / Corticoesteroides / Antagonistas Muscarínicos / Enfermedad Pulmonar Obstructiva Crónica / Agonistas de Receptores Adrenérgicos beta 2 / Androstadienos Tipo de estudio: Clinical_trials / Guideline / Observational_studies / Risk_factors_studies Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Eur Respir J Año: 2016 Tipo del documento: Article País de afiliación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Quinuclidinas / Alcoholes Bencílicos / Clorobencenos / Corticoesteroides / Antagonistas Muscarínicos / Enfermedad Pulmonar Obstructiva Crónica / Agonistas de Receptores Adrenérgicos beta 2 / Androstadienos Tipo de estudio: Clinical_trials / Guideline / Observational_studies / Risk_factors_studies Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Eur Respir J Año: 2016 Tipo del documento: Article País de afiliación: Estados Unidos