MedTrace Logo

Efficacy and Safety Study of GSK679586 in Patients With Severe Asthma

NCT00843193 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2017-12-12

Study results available
· View outcomes & findings →

Summary

Treatment, Randomised, Double Blind, Parallel Assignment, Safety/efficacy Study

Conditions

Interventions

DRUG

INTRAVENOUS GSK679586

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

DRUG

INTRAVENOUS PLACEBO

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

DRUG

FLUTICASONE PROPIONATE

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-09
Primary Completion
2010-07-25
Completion
2010-07-25

Countries

  • United States
  • France
  • Germany
  • Netherlands
  • Norway
  • Poland
  • South Africa
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00843193 on ClinicalTrials.gov