Bronchodilator Effect of RPL554 Administered in Addition to Tiotropium/Olodaterol in Patients With COPD
Summary
The study investigates the effect of 3 days of twice daily treatment of two different doses of RPL554 (a phosphodiesterase \[PDE\]3/4 inhibitor) or placebo, each administered in addition to once daily tiotropium/olodaterol (Respimat) in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Patients will receive each of the three treatment combinations in a randomized sequence using a crossover design
Timeline
- Start
- 2018-07-16
- Primary completion
- 2018-11-13
- Completion
- 2018-11-13
Outcome
Missed primary endpoint
registry analysis (other test); 1.5 mg RPL554 and Tiotropium/Olodaterol vs Placebo and Tiotropium/Olodaterol; p = 0.168; GeoMean Ratio 1.021 (95% CI 0.991 to 1.052); ANCOVA NCT03673670 ↗
registry analysis (other test); 6 mg RPL554 and Tiotropium/Olodaterol vs Placebo and Tiotropium/Olodaterol; p = 0.731; GeoMean Ratio 0.995 (95% CI 0.966 to 1.025); ANCOVA NCT03673670 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ensifentrine | Unknown | 1.5 mg | Inhaled |
| Subject | Ensifentrine | Unknown | 6 mg | Inhaled |
| Background | Olodaterol | Small molecule | 5 ug | — |
| Background | Tiotropium | Other / unclassified | 5 ug | — |