NCT07132983

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

A Phase II, Randomized, Double-Blind, Cross-Over 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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Verona Pharma plc · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Enrolled participants will be expected to participate for approximately 7 weeks: 1 to 2 weeks for screening, 5 single doses of study medication with each dose followed by an approximately 7-day washout period (total of 5 weeks), and 1 week of follow-up. Participants will be randomized to receive all the treatments in different sequences. The primary objective of the study is to evaluate the pharmacokinetics of the fixed-dose combination of ensifentrine and glycopyrrolate compared to each drug alone and to ensifentrine in a different formulation.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Ensifentrine 3 mg	Single dose, administered by oral inhalation using a standard jet nebulizer
DRUG	Glycopyrrolate 42.5 mcg	Single dose, administered by oral inhalation using a standard jet nebulizer
DRUG	Ensifentrine 1.5 mg	Single dose, administered by oral inhalation using a standard jet nebulizer
DRUG	Ensifentrine 3 mg (marketed formulation)	Single dose, administered by oral inhalation using a standard jet nebulizer

Timeline

• Start date: 2025-10-06
• Primary completion: 2025-11-28
• Completion: 2025-11-28
• First posted: 2025-08-20
• Last updated: 2026-01-08

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study