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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00732472 |
The study drug which is an inhaled bronchodilator (lung airway relaxant)has been given to both healthy volunteers and to COPD patients before. This study will assess a new formulation of GSK573719. Many drugs are known to deteriorate over time. To make the study medicine less likely to deteriorate in its container, it is mixed with an inactive substance that helps to to maintain the quality of the study medicine. Previous studies have looked at GSK573719 with another inactive substance called Cellobiose Octaacetate (COA). This study will be looking at a new formulation of GSK573719 using Magnesium Stearate (MgSt) as the inactive substance. MgSt itself is not a medicine but is approved as a food ingredient and has also has been approved to be used in a number of marketed medical inhalers. The purpose of this study is to assess the safety and tolerability of compound GSK573719 with Magnesium Stearate for once-daily treatment of COPD(Chronic Obstructive Pulmonary Disease). This drug will be given to 2 groups of 12 people for 7 days. Group 1 will receive 250mcg or placebo and group 2 will receive 1000mcg or placebo. Group 2 will not be dosed until at least 6 people have completed dosing in group 1 without any significant safety concerns. The following safety measures will be assessed including: ECGs, heart rate, blood pressure, blood samples for safety labs, lung function and 24 hour monitoring of the heart. We will also take blood and urine samples to measure medication levels in the body. GlaxoSmithKline will be funding the research and it will be recruiting at Synexus in 7 of their centres in the UK.
Condition | Intervention | Phase |
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Chronic Obstructive Pulmonary Disease (COPD) |
Drug: GSK573719 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety Study |
Official Title: | A Randomised, Double-Blind, Placebo-Controlled, Dose Ascending, 2-Cohort, Parallel Group Study to Examine the Safety, Tolerability and Pharmacokinetics of Once-Daily Inhaled Doses of GSK573719 Formulated With the Excipient Magnesium Stearate in COPD Subjects for 7 Days |
Estimated Enrollment: | 24 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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7 day repeat dose: Experimental |
Drug: GSK573719
7 day repeat dose
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Ages Eligible for Study: | 40 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A female subject is eligible to participate if she is of:
Exclusion Criteria:
The detection of drugs taken for a legitimate medical purpose would not necessarily be an exclusion to study participation. The detection of alcohol would not be an exclusion at screening but would need to be negative pre-dose and during the study.
History of high alcohol consumption within 1 month of the study defined as:
Respiratory criteria
Subject has poorly controlled COPD, defined as the occurrence of any of the following:
Cardiovascular criteria
Concurrent medication criteria
(Note, subjects may resume use of their usual medication in between screening and the treatment period if the restrictions in Section 9 Concomitant Medications and Non-Drug Therapies are followed and provided the long acting bronchodilator component is stopped again 48h or more prior to dosing).
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Germany | |
GSK Investigational Site | Withdrawn |
Berlin, Germany, D-14050 | |
United Kingdom | |
GSK Investigational Site | Recruiting |
Clydebank, Glasgow, United Kingdom, G81 2DR | |
GSK Investigational Site | Recruiting |
Llanishen, United Kingdom, CF14 5GJ | |
GSK Investigational Site | Recruiting |
Edgaston, Birmingham, United Kingdom, B15 2SQ | |
United Kingdom, Berkshire | |
GSK Investigational Site | Recruiting |
Reading, Berkshire, United Kingdom, RG2 0TG | |
United Kingdom, Lancashire | |
GSK Investigational Site | Recruiting |
Manchester, Lancashire, United Kingdom, M15 6SX | |
GSK Investigational Site | Recruiting |
Buckshaw Village, Chorley, Lancashire, United Kingdom, PR7 7NA | |
United Kingdom, Merseyside | |
GSK Investigational Site | Recruiting |
Waterloo, Liverpool, Merseyside, United Kingdom, L22 0LG |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 105211 |
Study First Received: | August 11, 2008 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00732472 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Chronic Obstructive Pulmonary Disease (COPD) GSK573719 Magnesium stearate |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive |