drugset / Trial / NCT07016412
Clinical Study of Ensifentrine-Glycopyrrolate (MK-5884A/RPL554) Fixed-dose Combination Dose Ranging in Participants With COPD (MK-5884A-029/RPL554-CO-212)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study will assess the safety and efficacy of fixed dose combinations of ensifentrine with two different glycopyrrolate dose levels compared to placebo and to the individual components of the fixed dose combinations, each administered twice a day via standard jet nebulizer, in adult participants with chronic obstructive pulmonary disease (COPD).
Timeline
- Start
- 2025-07-31
- Primary completion
- 2026-08-17
- Completion
- 2026-08-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ensifentrine | Unknown | 3 mg | Inhaled |
| Subject | Glycopyrrolate | Small molecule | 21.25 ug | Inhaled |
| Subject | Glycopyrrolate | Small molecule | 42.5 ug | Inhaled |