Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
125/ once-daily GSK573719/GW642444 · 1 trial · 1 indication
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury with hyperbilirubinaemia. Medical or scientific judgment was to have been exercised in other important medical events. AEs with an onset on or after the date of the first dose of study drug and up to 1 day after the date of the last recorded dose of study drug were considered to be on-treatment AEs, Refer to the general AE/SAE module for a complete list of AEs and SAEs.
| Arm | Type | Description |
|---|---|---|
| GSK573719/GW642444 | EXPERIMENTAL | 125/25 mcg once-daily |
| GSK573719 | EXPERIMENTAL | 125 mcg once-daily |
| Placebo | PLACEBO_COMPARATOR | inactive |
| Name | Type | Description |
|---|---|---|
| 125/25 mcg once-daily GSK573719/GW642444 | DRUG | GSK573719/GW642444 |
| 125mcg once-daily GSK573719 | DRUG | GSK573719 |
| Placebo once-daily | DRUG | inactive |
Inclusion Criteria: * outpatient * signed and dated written informed consent * 40 years of age or older * male and female subjects * COPD diagnosis * at least 10 pack-year smoking history * post-albuterol/salbutamol FEV1/FVC ratio of \<0.70 and post-albuterol/salbutamol FEV1 greater than or equal t...
GSK573719/GW642444 is an investigational combination therapy being studied for the treatment of chronic obstructive pulmonary disease (COPD). It is a small molecule developed by GSK plc (GSK) and is currently in Phase 3 clinical development. The drug is not yet approved and remains under investigation.
GSK573719/GW642444 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The drug is a small molecule combination therapy intended for the treatment of chronic obstructive pulmonary disease (COPD).
GSK573719/GW642444 is in Phase 3 clinical development for chronic obstructive pulmonary disease (COPD). It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy.
GSK573719/GW642444 has been studied in a Phase 3 clinical trial registered as NCT01316887. This was a 52-week, multicenter, randomized, double-blind, placebo-controlled study that evaluated the safety and tolerability of GSK573719/GW642444 in subjects with chronic obstructive pulmonary disease (COPD). The trial enrolled 563 participants and has been completed.
GSK573719/GW642444 is a combination therapy that includes GSK573719 as one of its components. In the clinical trial NCT01316887, both GSK573719/GW642444 and GSK573719 alone were evaluated in subjects with chronic obstructive pulmonary disease (COPD). The combination product is distinct from the single-agent GSK573719.