A phase III randomised controlled trial of single-dose triple therapy in COPD: the IMPACT protocol

Autor: Mark T. Dransfield, Rajat Mohindra, Ian D. Pavord, Steven Pascoe, Noushin Brealey, Helen Barnacle, David A. Lipson, Nicholas Locantore, Neil Barnes
Rok vydání: 2016
Předmět:
Adult
Male
Pulmonary and Respiratory Medicine
Quinuclidines
medicine.medical_specialty
Exacerbation
Muscarinic Antagonists
Chlorobenzenes
Fluticasone propionate
law.invention
Pulmonary Disease
Chronic Obstructive
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Double-Blind Method
Randomized controlled trial
Adrenal Cortex Hormones
law
Internal medicine
Humans
Medicine
Prospective Studies
030212 general & internal medicine
Prospective cohort study
Adrenergic beta-2 Receptor Agonists
Benzyl Alcohols
Aged
COPD
business.industry
Middle Aged
medicine.disease
Obstructive lung disease
Bronchodilator Agents
Androstadienes
Clinical trial
Phenotype
030228 respiratory system
chemistry
Practice Guidelines as Topic
Physical therapy
Drug Therapy
Combination
Female
Vilanterol
business
medicine.drug
Zdroj: European Respiratory Journal. 48:320-330
ISSN: 1399-3003
0903-1936
DOI: 10.1183/13993003.02165-2015
Popis: 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 β2-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.
Databáze: OpenAIRE
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