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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00144859 | Safety And Anti-Inflammatory Effect Of SB681323 In Patients With Chronic Obstructive Pulmonary Disease (COPD) | PHASE2 | COMPLETED | 82 | — | — | Jul 1, 2005 | - | Jun 4, 2012 | 17 | Denmark, Finland +3 |
| NCT00380133 | Study of SB681323 and Prednisolone on Biomarkers in COPD (Chronic Obstructive Pulmonary Disease) Patients | PHASE1 | COMPLETED | 20 | — | — | Jun 1, 2005 | Apr 1, 2006 | Jun 4, 2012 | 1 | United Kingdom |
Levels of ex-vivo LPS induced TNFα in whole blood at 1, 2, 6 and 24 hrs post-dose
| Arm | Type | Description |
|---|---|---|
| Randomised, double-blind, five-way crossover | EXPERIMENTAL | A randomised, double-blind, double-dummy, placebo-controlled, five-way crossover study to assess the effects of single oral doses of SB-681323 (7.5 mg and 25 mg) and prednisolone (10 mg and 30 mg) on biomarkers in induced sputum and blood in COPD patients. |
| Name | Type | Description |
|---|---|---|
| SB681323 | DRUG | - |
| Prednisolone | DRUG | 5 mg size DB AA capsule shell (Swedish orange) with a powder backfill (lactose Anhydrous) |
| Placebo | DRUG | Tablets matched to SB681323 or prednisolone |
Inclusion criteria: * Non-childbearing potential. * Clinical diagnosis of COPD. * Cigarette smoking history of greater than or equal to 10 pack years. * Post-bronchodilator FEV1 to FVC ratio (FEV1:FVC) \< 0.7 * Post-bronchodilator FEV1 50% - 80% of predicted normal. * Receiving inhaled corticostero...