A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of GSK2269557 Administered as a Dry Powder to Chronic Obstructive Pulmonary Disease (COPD) Patients
This is a randomised, double-blind, placebo controlled, parallel group study to evaluate the safety, tolerability and pharmacokinetics of multiple doses of GSK2269557 administered as a dry powder in COPD patients. Pharmacodynamic effects on biomarkers will also be assessed.
A sufficient number of COPD patients (male and female of non-child bearing potential) will be screened to ensure that approximately 30 subjects are enrolled and at least 20 evaluable subjects are obtained. Patients will be randomized to receive either GSK2269557 or the matching placebo, once daily for 14 consecutive days. Subjects will be randomized to active or placebo in a 3:1 ratio.
Placebo control will be included for a valid evaluation of adverse events attributable to treatment versus those independent of treatment.
|Study start date||2014-01-05|