Conditions: Asthma
Keywords: Asthma Asthma control questionnaire
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 198
Healthy volunteers: no

Brief summary:
Treatment, Randomised, Double Blind, Parallel Assignment, Safety/efficacy Study

Detailed description:
A Multi-Centre, Multi-country, Randomized, Double-Blind (Subject, Investigator), Placebo-Controlled, Repeat-Dose study to evaluate the Efficacy and Safety of Intravenous GSK679586 in Patients with Severe Asthma

Arms:
arm 1: Subjects will receive three, once monthly intravenous administration of 10 mg/kg of GSK679586, according to randomization arm 2: Subjects will receive three, once monthly intravenous administration of saline, according to randomization

Interventions: intervention 1: INTRAVENOUS GSK679586 intervention 2: INTRAVENOUS PLACEBO intervention 3: FLUTICASONE PROPIONATE
Intervention descriptions: intervention 1: GSK679586 will be provided as a clear or colorless to pale yellow liquid with the unit dose strength of 10mg/kg and will be infused over an hour. The infusion will be delivered by a programmable infusion pump intervention 2: Clear or colorless 0.9% sodium chloride saline solution will be infused over an hour. The infusion will be delivered by a programmable infusion pump intervention 3: Subjects will be supplied fluticasone propionate at Screening, Run-in and when needed during the study. Subjects will be up-titrated to 1000 μg/day and those who were already taking greater than equal to 1000 μg/day fluticasone propionate or equivalent prior to the study will remain on their pre-study dose.

Protocol document: