Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK573179 · 1 trial · 1 indication
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 15 is defined as the value obtained 24 hours after the morning dose administered on Day 14. Analysis were performed using a mixed model with covariates of mean Baseline, period Baseline, treatment and period as fixed effects and participant as a random effect. Baseline is the FEV1 value recorded pre-dose on Day 1 of each treatment period; mean Baseline is the mean of the Baselines for each participant and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline for each treatment period is the trough FEV1 at Day 15 minus the Baseline value for that treatment period.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Tiotropium | ACTIVE_COMPARATOR | Tiotropium |
| Arm 1 | EXPERIMENTAL | GSK573719 1000mcg once daily |
| Arm 2 | EXPERIMENTAL | GSK573719 500mcg once daily |
| Arm 3 | EXPERIMENTAL | GSK573719 250mcg once daily |
| Arm 4 | EXPERIMENTAL | GSK573719 125mcg once daily |
| Arm 5 | EXPERIMENTAL | GSK573719 62.5 mcg once daily |
| Arm 6 | EXPERIMENTAL | GSK573719 250mcg twice daily |
| Arm 7 | EXPERIMENTAL | GSK573719 125mcg twice daily |
| Arm 8 | EXPERIMENTAL | GSK573719 62.5mcg twice daily |
| Name | Type | Description |
|---|---|---|
| Tiotropium | DRUG | long-acting muscarinic receptor antagonist; 18mcg once-daily |
| Placebo | DRUG | Inactive/ excipients only |
| GSK573179 | DRUG | GSK573179 investigational drug |
Inclusion Criteria: * A signed and dated written informed consent prior to study participation * Males or females of non-childbearing potential * 40 to 80 years of age * COPD diagnosis * 10 pack-years history or greater of cigarette smoking * Post-bronchodilator FEV1/FVC ratio of 0.70 or less * Pos...
GSK573179 is being developed for chronic obstructive pulmonary disease, a respiratory condition. It is an investigational small molecule studied in a Phase 2 dose ranging trial in adults with COPD. It has not been approved for any use.
GSK573179 is developed by GSK plc, which trades under the ticker GSK. The company sponsored the Phase 2 dose ranging study of the drug in chronic obstructive pulmonary disease.
GSK573179 is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The drug remains investigational and is not approved for any indication.
GSK573179 has been studied in one completed Phase 2 trial, NCT00950807, titled GSK573719 Dose Ranging Study in Chronic Obstructive Pulmonary Disease. It enrolled 176 adults aged 40 and older across the United States and Germany and was randomized, double blind, and placebo controlled.
GSK573179 and GSK573719 refer to the same compound. The completed Phase 2 dose ranging study in chronic obstructive pulmonary disease was registered under the name GSK573719, while the asset is also listed as GSK573179.