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)

NCT07016412 ↗

Phase 2 Completed 497 enrolled Verona Pharma, Inc.
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

EvaluationDrugModalityDoseRoute
Subject Ensifentrine Unknown 3 mg Inhaled
Subject Glycopyrrolate Small molecule 21.25 ug Inhaled
Subject Glycopyrrolate Small molecule 42.5 ug Inhaled