Approval Probability
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Adjusted LOA
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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...
125/ once-daily GSK573719/GW642444 is an investigational small molecule combination therapy being developed by GSK plc for chronic obstructive pulmonary disease (COPD). It is a once-daily inhaled treatment studied in a Phase 3 clinical program. The combination is also referred to as 125/25 mcg once-daily GSK573719/GW642444.
125/ once-daily GSK573719/GW642444 is being studied for the treatment of chronic obstructive pulmonary disease, commonly called COPD. The Phase 3 trial enrolled adults aged 40 years and older with COPD across sites in the United States, Chile, Romania, Russia, Slovakia, and South Africa.
GSK plc, which trades under the ticker GSK, is the developer of 125/ once-daily GSK573719/GW642444. The company sponsored the Phase 3 study evaluating the combination in patients with chronic obstructive pulmonary disease.
125/ once-daily GSK573719/GW642444 is in Phase 3 development. It is an investigational therapy and has not been approved by the FDA. The Phase 3 trial has been completed, and no active trials for this combination are currently listed.
125/ once-daily GSK573719/GW642444 was evaluated in one Phase 3 trial, NCT01316887. This was a 52-week, multicenter, randomized, double-blind, parallel-group, placebo-controlled study assessing the safety and tolerability of the combination and of GSK573719 alone in 563 subjects with COPD. The trial is completed.