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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

NCT07132983 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-01-08

No results posted yet for this study

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).

Conditions

Interventions

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

Sponsors & Collaborators

  • Verona Pharma plc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-06
Primary Completion
2025-11-28
Completion
2025-11-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07132983 on ClinicalTrials.gov