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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05046795 | Revefenacin in Chinese Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease(COPD) | PHASE3 | COMPLETED | 258 | — | — | Nov 10, 2021 | Jul 26, 2023 | Nov 1, 2024 | 35 | China |
Change from Baseline (Day 1, pre-dose) trough FEV1 on Day 85
Sensitivity analysis results of change from baseline in trough FEV1 (mL) on Day 85 with missing data imputed by last observation carried forward
| Arm | Type | Description |
|---|---|---|
| Revefenacin inhalation solution 175 mcg QD. | EXPERIMENTAL | Revefenacin inhalation solution 175 mcg QD. |
| Placebo inhalation solution QD. | PLACEBO_COMPARATOR | Placebo inhalation solution QD. |
| Name | Type | Description |
|---|---|---|
| Revefenacin 175 mcg in 3 ML Inhalation Solution | DRUG | Revefenacin |
| Placebo inhalation solution QD | DRUG | Placebo |
Inclusion Criteria: * Key inclusion criteria include: * Males and females of Chinese ethnicity, at least 40 years of age. Females may be of either childbearing or non-childbearing potential. All females of childbearing potential must be using an acceptable, highly effective method of contracepti...