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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03012061 | Phase IIb Study of Umeclidinium (UMEC) Bromide Versus Placebo in Subjects With Asthma | PHASE2 | COMPLETED | 425 | — | — | Jan 25, 2017 | May 30, 2018 | Oct 28, 2020 | 70 | United States, Canada +3 |
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...