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Revefenacin in Chinese Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease(COPD)

NCT05046795 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2024-11-01

Study results available
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Summary

This study is a phase III clinical study to assess the efficacy and safety of Revefenacin inhalation solution 175 mcg administered once daily via nebulization for 12 weeks compared to placebo in a population of Chinese subjects with moderate to very severe COPD.

Conditions

Interventions

DRUG

Revefenacin 175 mcg in 3 ML Inhalation Solution

Revefenacin

DRUG

Placebo inhalation solution QD

Placebo

Sponsors & Collaborators

  • Mylan Pharma UK Ltd.

    lead INDUSTRY

Principal Investigators

  • Dik WH Ng, PhD · Mylan Pharmaceuticals Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-10
Primary Completion
2023-07-26
Completion
2023-07-26

Countries

  • China

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 NCT05046795 on ClinicalTrials.gov