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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02573870 | Batefenterol/Fluticasone Furoate in Treatment of Chronic Obstructive Pulmonary Disease | PHASE2 | COMPLETED | 63 | — | — | Dec 1, 2015 | Jul 5, 2016 | Jul 21, 2020 | 10 | United States |
| NCT02570165 | Dose-Finding Study of Batefenterol (GSK961081) Via Dry Powder Inhaler in Patients With Chronic Obstructive Pulmonary Disease (COPD) | PHASE2 | COMPLETED | 325 | — | — | Nov 6, 2015 | Jul 6, 2016 | Jul 16, 2019 | 25 | United States, Germany +1 |
ECG measurements were taken in supine position after obtaining vital signs. Weighted mean was derived by calculating the area under the curve (AUC), and then dividing by the relevant time interval. Baseline was the pre-dose measurement on Day 1. Change from Baseline in 0 to 4 hours post-dose weighted mean heart rate was measured on Days 1, 28 and 42 and was analyzed using a mixed models repeated measures (MMRM) model. Intent-To-Treat (ITT) Population: all randomized participants who received at least one dose of study medication.
FEV1 is defined as the volume of air that can be forced out in one second after taking a deep breath. Weighted-mean change from Baseline was the weighted-mean FEV1 on Day 42 minus Baseline where Baseline is defined as the average of Day1 pre-dose FEV1 measured at -30 minutes and 0 minutes. The 0-6 hour (Hr.) serial FEV1 was collected at Day 1 (Visit 2) and Day 42 (Visit 6). The weighted-mean was derived by calculating the area under the curve (AUC) of FEV1 over the 6 hour period, and then dividing it by the 6-hour time interval. Batefenterol dose for each individual was compared with placebo or UMEC/VI. The change from Baseline in FEV1 was statistically analyzed using Bayesian Emax modeling of the dose response curve. Intent-to-Treat (ITT) Population comprised of all participants randomized to treatment and who received at least one dose of study medication. Participants with FEV1 values available at Baseline and Day 42 were analyzed.
| Arm | Type | Description |
|---|---|---|
| Batefenterol + Fluticasone Furoate | EXPERIMENTAL | Subjects will self-administer batefenterol/fluticasone furoate 300/100 micrograms inhalation powder once daily for 42 days. Albuterol will be provided from screening to Day 42, to use as needed for symptom relief. |
| Placebo | PLACEBO_COMPARATOR | Subjects will self-administer matching placebo inhalation powder once daily for 42 days. Albuterol will be provided from screening to Day 42, to use as needed for symptom relief. |
| Batefenterol 37.5 mcg | EXPERIMENTAL | Each subject will receive batefenterol 37.5 mcg (1 actuation) once daily via DPI in the morning for 42 days of treatment period. |
| Batefenterol 75 mcg | EXPERIMENTAL | Each subject will receive batefenterol 75 mcg (1 actuation) once daily via DPI in the morning for 42 days of treatment period. |
| Batefenterol 150 mcg | EXPERIMENTAL | Each subject will receive batefenterol 150 mcg (1 actuation) once daily via DPI in the morning for 42 days of treatment period. |
| Batefenterol 300 mcg | EXPERIMENTAL | Each subject will receive batefenterol 300 mcg (1 actuation) once daily via DPI in the morning for 42 days of treatment period. |
| Batefenterol 600 mcg | EXPERIMENTAL | Each subject will receive batefenterol 600 mcg (1 actuation) once daily via DPI in the morning for 42 days of treatment period. |
| UMEC/VI 62.5/25 mcg | EXPERIMENTAL | Each subject will receive UMEC/VI 62.5/25 mcg (1 actuation) once daily via DPI in the morning for 42 days of treatment period. |
| Name | Type | Description |
|---|---|---|
| Batefenterol + Fluticasone Furoate | DRUG | Batefenterol and Fluticasone Furoate (FF) will be provided as a fixed-dose combination in a dry powder inhaler (DPI), for oral inhalation once every morning, for 42 days. The DPI will consist of 2 strips of 30 blisters each, containing 300 microgram (mcg) batefenterol per blister in one strip and 100 mcg FF per blister in another strip. Both drugs will be available in a micronized form, blended with lactose monohydrate. |
| Placebo | DRUG | Placebo will be provided in a DPI, for oral inhalation once every morning, for 42 days. The DPI will consist of 2 matching strips of 30 blisters each, with each blister containing lactose monohydrate and no active pharmaceutical ingredient. |
| Albuterol | DRUG | Albuterol inhalation will be provided as an open-label rescue medication to use as needed, to relieve chronic obstructive pulmonary disease (COPD) symptoms. |
| Batefenterol | DRUG | Batefenterol will be provided as dry white powder for inhalation via a DPI with 30 doses (2 strips with 30 blisters per strip). First strip will contain lactose and the second strip will contain batefenterol blended with lactose with a unit dose strength of 37.5 mcg, 75 mcg, 150 mcg, 300 mcg, or 600 mcg per blister |
| Umeclidinium/ Vilanterol | DRUG | Umeclidinium/Vilanterol will be provided as dry white powder for inhalation via a DPI with 30 doses (2 strips with 30 blisters per strip). First strip will contain umeclidinium blended with lactose and magnesium stearate with a unit dose strength of 62.5 mcg per blister and the second strip will contain vilanterol blended with lactose and magnesium stearate with a unit dose strength of 25 mcg per blister |
Inclusion Criteria: * Type of subject: Outpatient. * Informed Consent: Capable of giving signed informed consent, which includes compliance with pre-specified requirements and restrictions. * Age and gender: Male and female subjects, 40 years of age or older at the time of signing the informed cons...