Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
UMEC · 1 trial · 1 indication
FEV1 is measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The highest of 3 technically acceptable measurements were recorded at each Visit. The Baseline value of clinic FEV1 was last acceptable/borderline acceptable (pre-dose) FEV1 value obtained prior to randomized treatment start date. Change from Baseline was calculated as FEV1 value at Week 24 minus FEV1 value at Baseline. Treatment policy estimand was assessed, including all on- and post-treatment data. Intent-to-Treat Population comprised all randomized participants, excluding those who were randomized in error, who did not receive the study drug. Least square (LS) mean and standard error (SE) data is presented. Different participants may have been analyzed at different time points; thus, overall number of participants analyzed reflects everyone in ITT Population without missing covariate information, with Baseline, at least one post-Baseline measurement.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Subjects will be administered placebo once daily via the ELLIPTA® dry powder inhaler (DPI) for 24 weeks. Subjects will also receive FF 100 mcg once daily, in the morning for 24 weeks. ELLIPTA is a registered trademark of the GSK group of companies. |
| UMEC 62.5 mcg | EXPERIMENTAL | Subjects will be administered UMEC 62.5 mcg once daily via the ELLIPTA dry powder inhaler (DPI) for 24 weeks. Subjects will also receive FF 100 mcg once daily, in the morning for 24 weeks. |
| UMEC 31.25 mcg | EXPERIMENTAL | Subjects will be administered UMEC 31.25 mcg once daily via the ELLIPTA dry powder inhaler (DPI) for 24 weeks. Subjects will also receive FF 100 mcg once daily, in the morning for 24 weeks. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo is a white powder to be administered using ELLIPTA DPI which hold two individual blister strips, both of which contains lactose monohydrate blended with magnesium stearate. |
| UMEC | DRUG | UMEC is a white powder to be administered using ELLIPTA DPI which hold two individual blister strips, one of which contains GSK573719 blended with lactose blended with magnesium stearate and another one contains lactose monohydrate blended with magnesium stearate. |
| Fluticasone Furoate | DRUG | FF is a white powder to be administered using ELLIPTA DPI which hold two individual blister strips, one of which contains GW685698 blended with lactose monohydrate and another one contains lactose monohydrate with magnesium stearate. |
| Albuterol/salbutamol | DRUG | Albuterol/salbutamol is to be administered via metered-dose inhaler as a rescue drug on need basis throughout the study. |
Inclusion Criteria: * 18 years of age or older at the time of signing the informed consent. * Subjects with a diagnosis of asthma as defined by the National Institutes of Health at least 6 months prior to Visit 0. * Asthma Control Questionnaire (ACQ)-6 total score of \>0.75 at Visit 1. * Subjects a...
UMEC is an investigational small molecule being developed for respiratory conditions, specifically asthma and chronic obstructive pulmonary disease (COPD). It is being studied as a treatment to address these chronic lung diseases, with clinical trials evaluating its efficacy and safety in patients with these conditions.
UMEC is being developed by GSK plc, a global pharmaceutical company traded on the stock exchange under the ticker symbol GSK. GSK is conducting clinical trials to evaluate the drug's potential in treating respiratory diseases such as asthma and COPD.
UMEC is in Phase 2 clinical development for asthma, based on a completed Phase IIb study. It has also been studied in Phase 1 and Phase 3 trials for chronic obstructive pulmonary disease (COPD). The drug is investigational and not yet approved for any use.
UMEC has been studied in several clinical trials, including NCT01691547 and NCT01899638 (Phase 1 in healthy subjects), NCT02152605 (Phase 3 in COPD), and NCT03012061 (Phase 2b in asthma). All trials are completed, with a total enrollment of 2,229 participants.
UMEC is an abbreviation for umeclidinium, a long-acting muscarinic antagonist. In clinical trials, it is often studied in combination with other drugs like vilanterol. The drug is being developed by GSK for respiratory conditions including asthma and COPD.