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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02542254 | The Effects of RPL554 on Top of Standard COPD Reliever Medications | PHASE2 | COMPLETED | 36 | — | — | Oct 1, 2015 | Dec 1, 2015 | Sep 9, 2016 | 1 | United Kingdom |
Forced expired volume in one second (FEV1) over 8 hours post-dose
| Arm | Type | Description |
|---|---|---|
| Salbutamol alone | ACTIVE_COMPARATOR | 200 micrograms salbutamol, ipratropium matched placebo and RPL554 matched placebo |
| Salbutamol and RPL554 | EXPERIMENTAL | 200 micrograms salbutamol, ipratropium matched placebo and 6 mg RPL554 |
| Ipratropium | ACTIVE_COMPARATOR | Salbutamol matched placebo, 40 micrograms ipratropium and RPL554 matched placebo |
| Ipratropium and RPL554 | EXPERIMENTAL | Salbutamol matched placebo, 40 micrograms ipratropium and 6 mg RPL554 |
| RPL554 | EXPERIMENTAL | Salbutamol matched placebo, ipratropium matched placebo and 6 mg RPL554 |
| Placebo | PLACEBO_COMPARATOR | Salbutamol matched placebo, ipratropium matched placebo and RPL554 matched placebo |
| Name | Type | Description |
|---|---|---|
| Salbutamol | DRUG | 200 micrograms salbutamol administered using a pressurised metered dose inhaler (pMDI) |
| Ipratropium | DRUG | 40 micrograms ipratropium administered using a pMDI |
| RPL554 | DRUG | 6 mg RPL554 administered using a nebuliser |
| Salbutamol matched placebo | DRUG | Placebo pMDI |
| Ipratropium matched placebo | DRUG | Placebo pMDI |
| RPL554 matched placebo | DRUG | Nebulised placebo |
Inclusion Criteria: * Provide informed consent * Males not donating sperm and using adequate contraception or females who are surgically sterile or postmenopausal * 12-lead ECG showing:Heart rate 45 to 90 bpm, QTcF≤450 msec, QRS ≤120 msec, PR interval ≤220 msec, no clinically significant abnormalit...