Research Study

A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety, Efficacy and Changes in Induced Sputum and Blood Biomarkers Following Daily Repeat Doses of Inhaled GSK2269557 for 12 Weeks in Adult Subjects Diagnosed With an Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Principal Investigator 
Mark FitzGerald

Overview

Body Locations and Systems 
COPD
Disorders and Conditions 
Smoking
ClinicalTrials.gov# 
NCT02522299
Status 
Recruiting
Study Start/End 
Sep 24, 2015 to Dec 31, 2017
Locations 
Diamond Health Care Centre, Vancouver General Hospital
Name/Title 
Linda Hui, Research Coordinator
Phone 
604-875-5697
Purpose of Study 

The purpose of this study is to evaluate specific alterations in immune cell mechanisms related to neutrophil function as detected by PI3Kdelta-dependent changes in messenger ribonucleic acid (mRNA) extracted from induced sputum in patients experiencing an exacerbation of COPD, with or without treatment with GSK2269557. The efficacy of treatment with GSK2269557 will also be measured using functional respiratory imaging (FRI) and spirometry. This is a randomised, double-blind, placebo-controlled, parallel-group study. The study consisted of Screening Phase (up to 3 days prior to Day 1), Treatment Phase (Days 1 to 84) and Follow phase (7 to 14 days after last dose). The total duration of the study is 13-14 weeks including the screening visit.

Eligibility 

Visit ClinicalTrials.gov for more information.

Disclaimer 

Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers and email addresses are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician.