At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-Blind (Sponsor Unblind), Placebo Controlled, Randomised, Parallel Group Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of GSK2269557 Administered as a Dry Powder to COPD Patients and Assessment of Dose Response Using Sputum Biomarkers
In Brief
A Phase 2 clinical trial evaluating GSK2269557 100 MCG, GSK2269557 500 MCG, and 1 other intervention for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 64 participants across 2 sites.
Detailed Summary
This is a randomised, double-blind, placebo controlled, parallel group study to evaluate the safety, tolerability, pharmacokinetics and dose response of multiple doses of GSK2269557 administered as a dry powder in COPD subjects. Pharmacodynamic effects on biomarkers will also be assessed. This study will have two parts. In Part A, subjects will be randomized to active or placebo treatment in a 3:1 ratio and in Part B, to placebo or one of the six doses of active treatment in an equal ratio. A sufficient number of COPD subjects (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 for Part A and approximately 35 subjects will be enrolled for Part B. In both the parts, subjects will receive study treatment once daily for 14 consecutive days. Placebo control will be included for a valid evaluation of adverse events attributable to treatment versus those independent of treatment.
Study Details
Timeline
Interventions
100 mcg of GSK2269557 blended with lactose per blister administered using a dry powder inhaler device
500 mcg of GSK2269557 blended with lactose per blister administered using a dry powder inhaler device
Lactose administered using a matching dry powder inhaler device