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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04315558 | Revefenacin in Acute Respiratory Insufficiency in COPD | PHASE2 | COMPLETED | 21 | — | — | Nov 1, 2020 | Jan 1, 2025 | Aug 13, 2025 | 2 | United States |
Reduction in total inspiratory resistance across the airways and ventilator circuit measured by the change in Static Resistance (Rstat) at the time of drug trough
| Arm | Type | Description |
|---|---|---|
| Revefenacin | EXPERIMENTAL | Revefenacin will be delivered once daily via nebulizer. In order to allow for full blinding and steady Q6 hours regimen in control arm, at hours 6, 12 and 18 after the Revefenacin dose, nebulized normal saline will be delivered. |
| Ipratropium | ACTIVE_COMPARATOR | Nebulized ipratropium will be delivered via nebulizer Q6 hours. |
| Name | Type | Description |
|---|---|---|
| Revefenacin Inhalation Solution [Yupelri] | DRUG | nebulized drug comparison |
| Ipratropium Bromide | DRUG | nebulized drug comparison |
Inclusion Criteria: * Adults ≥ 40 years of age * Acute respiratory failure requiring invasive mechanical ventilation * Documented history of COPD based on spirometric evidence of FEV1/FVC\<70% * Smoking history \>10 years (current or prior) * Invasive mechanical ventilation for \< 96 hours Exclusi...