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A Study to Evaluate the Efficacy and Safety of Ensifentrine for 24 Weeks in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

NCT05743075 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 526

Last updated 2025-06-04

No results posted yet for this study

Summary

This is a multi-center, randomized, double-blind, placebo-controlled, parallel-group clinical study, which aims to evaluate the efficacy, safety, and PK characteristics of Ensifentrine 3 mg twice daily (BID) for 24 weeks treatment of moderate to severe COPD.

Conditions

Interventions

DRUG

Ensifentrine

A dual PDE3/PDE 4 inhibitor

DRUG

Placebo

Placebo solution

Sponsors & Collaborators

  • Laboratory Corporation of America

    collaborator INDUSTRY

  • Nuance Pharma (shanghai) Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-03-10
Primary Completion
2024-12-06
Completion
2025-03-07
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
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 NCT05743075 on ClinicalTrials.gov