drugset / Trial / NCT07016412
A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD
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 subjects with chronic obstructive pulmonary disease (COPD).
Timeline
- Start
- 2025-07-31
- Primary completion
- 2026-08-05
- Completion
- 2026-08-05
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 |