Clinical Trial

A Phase II Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Single Inhaled Doses of Ensifentrine-glycopyrrolate Fixed Dose Combination, Ensifentrine, and Glycopyrrolate in Subjects With Chronic Obstructive Pulmonary Disease

Completed Phase 2
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Summary
This study will assess the pharmacokinetics (PK), pharmacodynamics (PD) and safety of ensifentrine and glycopyrrolate fixed dose (FDC) product, the individual components of the FDC (ensifentrine and glycopyrrolate, each in the FDC formulation), ensifentrine 1.5 mg in the FDC formulation and ensifentrine 3 mg in the marketed formulation each administered via a standard jet nebulizer, in adult participants with chronic obstructive pulmonary disease (COPD).
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-08-19; most recent amendment 2026-01-07.
Status change: Active, Not Recruiting → Completed 2026-01-07
Status change: Recruiting → Active, Not Recruiting 2025-10-24
Status change: Not Yet Recruiting → Recruiting 2025-09-29
Trial Details
NCT Number NCT07132983
Lead Sponsor Verona Pharma plc
Conditions Chronic Obstructive Pulmonary Disease
Enrollment 33 participants
Start Date 2025-10-06
Primary Completion 2025-11-28 (estimated)
Study Completion 2025-11-28 (estimated)
Updated on ClinicalTrials.gov 2026-01-08