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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03028142 | The Effects of RPL554 in Addition to Tiotropium in COPD Patients | PHASE2 | COMPLETED | 30 | — | — | Jan 1, 2017 | Aug 1, 2017 | Feb 27, 2019 | - | — |
Peak forced expired volume in 1 second (FEV1) over 4 hours on the third day of dosing
Average FEV1 area under the curve (AUC) over 12 hours on the third day of dosing
| Arm | Type | Description |
|---|---|---|
| Lower Dose Nebulised Treatment | EXPERIMENTAL | 1.5 mg nebulised RPL554 twice daily plus 10 mcg tiotropium DPI once daily for 3 days |
| Higher Dose Nebulised Treatment | EXPERIMENTAL | 6 mg nebulised RPL554 twice daily plus 10 mcg tiotropium DPI once daily for 3 days |
| Placebo | PLACEBO_COMPARATOR | Nebulised RPL554 matched placebo twice daily plus 10 mcg tiotropium DPI once daily for 3 days |
| Name | Type | Description |
|---|---|---|
| 1.5 mg RPL554 plus tiotropium | DRUG | - |
| 6 mg RPL554 plus tiotropium | DRUG | - |
| Placebo plus tiotropium | DRUG | - |
Inclusion Criteria: 1. Sign an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study. 2. Male or female aged between 40 and 75 years inclusive, at the time of informed consent. 3. If male: must agree to ...