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Mepolizumab as Add-on Treatment IN Participants With COPD Characterized by Frequent Exacerbations and Eosinophil Level

NCT04133909 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 806

Last updated 2025-08-15

Study results available
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Summary

This is a multi-center, randomized, placebo-controlled, double-blind, parallel group study designed to confirm the benefits of mepolizumab treatment on moderate or severe exacerbations in chronic obstructive pulmonary disease (COPD) participants given as an add on to their optimized maintenance COPD therapy. The maximum duration of participant participation is approximately 109 weeks, consisting of 2 screening visits (up to 3 weeks), a run-in period (up to 2 weeks), and an intervention period of at least 52 weeks and up to 104 weeks. 800 participants will be randomized in a 1:1 ratio to receive mepolizumab 100 milligrams (mg) or placebo every 4 weeks for at least 13 doses (52 weeks treatment period) up to a maximum of 26 doses (104 weeks treatment period). The number of randomized participants may increase up to approximately 1400.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

BIOLOGICAL

Mepolizumab

Mepolizumab was a sterile liquid formulation. It was administered as a subcutaneous injection (100 milligrams per milliliter \[mg/mL\]) delivered once every 4 weeks using a pre-filled safety syringe.

DRUG

Placebo

Placebo was a 0.9% sodium chloride solution. It was administered as a subcutaneous injection delivered once every 4 weeks using a pre-filled safety syringe.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-30
Primary Completion
2024-08-08
Completion
2024-08-08
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • China
  • Denmark
  • Estonia
  • France
  • Germany
  • Greece
  • Hungary
  • India
  • Ireland
  • Israel
  • Italy
  • Mexico
  • Netherlands
  • New Zealand
  • Poland
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • United Kingdom

Study Locations

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Entities

Drugs
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 NCT04133909 on ClinicalTrials.gov