CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 198 enrolled
Drug / intervention
INTRAVENOUS GSK679586 +2 moredrug
Likely dose
INTRAVENOUS GSK679586 10mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00843193
NCT00843193Phase 2Completed
CompareCT.gov

A Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Repeat-Dose Study to Evaluate the Efficacy and Safety of Intravenous GSK679586 in Patients With Severe Asthma

GlaxoSmithKline·interventional·Posted Feb 13, 2009·Updated Dec 12, 2017

In Brief

A Phase 2 clinical trial evaluating INTRAVENOUS GSK679586, INTRAVENOUS PLACEBO, and 1 other intervention for Asthma. Completed, enrolled 198 participants across 35 sites in 8 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesFrance, Germany, Netherlands, Norway, Poland, South Africa, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 13, 2009
Enrollment StartDec 9, 2008
Primary CompletionJul 25, 2010
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 17.4 years ago

Interventions

INTRAVENOUS GSK679586drug

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

INTRAVENOUS PLACEBOdrug

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

FLUTICASONE PROPIONATEdrug

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.