Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00843193 | Efficacy and Safety Study of GSK679586 in Patients With Severe Asthma | PHASE2 | COMPLETED | 198 | — | — | Dec 9, 2008 | Jul 25, 2010 | Dec 12, 2017 | 35 | United States, France +6 |
| NCT00411814 | A Study Of GSK679586A When Infused Into Healthy And Mild Asthmatic Volunteers | PHASE1 | COMPLETED | 56 | — | — | Nov 1, 2006 | Feb 1, 2008 | Mar 19, 2012 | 2 | Australia |
The ACQ-7 consists of 7 questions scored between zero (no impairment/ limitation) to 6 (total impairment/ limitation). The values of Week 1 is considered as Baseline. ACQ-7 was calculated as the average of the 7 scores. If any one individual score was missing, the ACQ-7 was set to missing.The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well.
| Arm | Type | Description |
|---|---|---|
| GSK679586 | EXPERIMENTAL | Subjects will receive three, once monthly intravenous administration of 10 mg/kg of GSK679586, according to randomization |
| PLACEBO | PLACEBO_COMPARATOR | Subjects will receive three, once monthly intravenous administration of saline, according to randomization |
| Active | ACTIVE_COMPARATOR | GSK679586 |
| Name | Type | Description |
|---|---|---|
| INTRAVENOUS GSK679586 | DRUG | 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 PLACEBO | DRUG | 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 PROPIONATE | DRUG | 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. |
| GSK679586 | DRUG | Active Drug |
| Placebo | DRUG | Saline |
Inclusion Criteria: * history of asthma for ≥ 6 months * taking inhaled corticosteroids * non-smoking * Baseline (pre-bronchodilator) FEV1 35-80% predicted at screening. * Reversible airways disease as indicated by an increase of FEV1 ≥12% from baseline after nebulised salbutamol or albuterol. * sy...