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Effect of Ensifentrine on Sputum Markers of Inflammation in COPD

NCT05270525 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-05-13

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled, two-period cross-over study of nebulized ensifentrine (3 mg) or placebo administered BID for two 8-week Treatment Periods. All participants with receive both ensifentrine and placebo during participation. There are 7 in-clinic visits over a total duration of up to 24 weeks participation.

Conditions

Interventions

DRUG

Ensifentrine

Ensifentrine twice daily administered with jet nebulizer for 8 weeks

DRUG

Placebo

Placebo ensifentrine twice daily administered with jet nebulizer for 8 weeks

Sponsors & Collaborators

  • University of Alabama at Birmingham

    collaborator OTHER

  • Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2022-05-27
Primary Completion
2026-12-31
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT05270525 on ClinicalTrials.gov