Pulmonary Disease, Chronic Obstructive Clinical Trial
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 Stearatein COPD Subjects for 7 Days
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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