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

Phase 2 Completed 33 enrolled Verona Pharma, Inc.

RandomizedCrossoverTriple-blindTreatment

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).

Timeline

Start: 2025-10-06
Primary completion: 2025-11-28
Completion: 2025-11-28

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ensifentrine	Unknown	1.5 mg	Inhaled
Subject	Ensifentrine	Unknown	3 mg	Inhaled
Subject	Glycopyrrolate	Small molecule	42.5 ug	Inhaled

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

Summary

Timeline

Drugs

Indications