Pulmonx Endobronchial Valves Used in Treatment of Emphysema (LIBERATE Study) (LIBERATE)

May 15, 2023 updated by: Pulmonx Corporation

Lung Function Improvement After Bronchoscopic Lung Volume Reduction With Pulmonx Endobronchial Valves Used in Treatment of Emphysema

The purpose of this research is to study an investigational medical device that is designed to produce lung volume reduction in diseased areas of the lungs in patients with severe emphysema.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Pulmonx Zephyr Endobronchial Valve (EBV) is an implantable bronchial valve intended to decrease volume in targeted regions of the lung. It is indicated for the treatment of patients with severe emphysema. The EBV are placed in the diseased region of the lung using bronchoscopy. Bronchoscopy is a way to access the lungs using a small tube with a camera on the end. As the diseased region of the lung shrinks in size, healthier regions may expand and function more efficiently, resulting in improved breathing.

The LIBERATE Study is a clinical trial with two groups. Participants are assigned at random to the 'Treatment' group or to the 'Control' group. The 'Treatment' group will receive the Zephyr Endobronchial Valve (EBV) in combination with optimal medical therapy. The 'Control' group will receive optimal medical therapy alone. For every three participants in the study, two will go into the 'Treatment' group and one will go into the 'Control' group.

It is hypothesized that after placement of the EBV, lung function will be improved as compared to standard medical therapy alone.

Based on the 12-month follow up data from the LIBERATE Study, the Zephyr Endobronchial Valve System was approved by the FDA for the treatment of severe emphysema in June 2018. Following this PMA approval, and in agreement with the FDA, the ongoing long term follow-up (out to 5 years) of patients in the LIBERATE Study will now be conducted as a Post-approval study under the auspices of the "LIBERATE Extension Study". This is an administrative change with absolutely no change to the design or conduct of the study and, therefore has no material impact to the study participants or the study sites. All annual follow-up visits and evaluations are per the original LIBERATE Study protocol. Reporting to the FDA will be as the LIBERATE Extension Study.

Study Type

Interventional

Enrollment (Actual)

190

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90035-903
        • Hospital de Clínicas Porto Alegre
    • SP
      • São Paulo, SP, Brazil, 05403-000
        • INCOR - Hospital das Clinicas de Faculdade de Medicine da USP
  • Netherlands
      • Groningen, Netherlands, 9700
        • University Medical Center Groningen
  • United Kingdom
      • Bristol, United Kingdom, BS2 8HW
        • Bristol Royal Infirmary
      • Cardiff, United Kingdom, CF14 4XW
        • University Hospital Llandough and University Hospital of Wales
      • London, United Kingdom, SW3 6NP
        • Royal Brompton & Harefield NHS Foundation Trust
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • The University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Arizona Pulmonary Specialists
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California
      • Mountain View, California, United States, 94040
        • El Camino Hospital
      • Sacramento, California, United States, 95817
        • University of California at Davis Medical Center
      • San Francisco, California, United States, 94143
        • University of California, San Francisco
      • Stanford, California, United States, 94507
        • Stanford University
      • Torrance, California, United States, 90502
        • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
    • Florida
      • Orlando, Florida, United States, 32806
        • Orlando Health
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Research Foundation
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Texas
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinical and radiological evidence of emphysema
  • Nonsmoking for 4 months prior to screening interview
  • BMI less than 35 kg/m2
  • Stable on current medication regimen
  • Forced expiratory volume in one second (FEV1) between 15% and 45% of predicted value
  • Residual Volume less than 175% predicted (determined by body plethysmography)
  • Little or no collateral ventilation (CV-) as determined using the Chartis System

Exclusion Criteria:

  • Had two or more hospitalizations over the last year for a COPD exacerbation
  • Had two or more hospitalizations over the last year for pneumonia
  • Had a prior lung transplant, lung volume reduction surgery, bullectomy or lobectomy
  • Had a heart attack or congestive heart failure within the last 6 months
  • Have heart arrhythmia
  • Is alpha-1 antitrypsin deficient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EBV and Optimal Medical Management
This study arm will undergo EBV treatment along with optimal medical management, including smoking cessation program, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
Device: EBV
This study arm will undergo EBV treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
Other: Optimal Medical Management
This study arm will receive maximal medical management, including smoking cessation program support if necessary, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
Other: Optimal Medical Management
This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced Expiratory Volume in 1-second (FEV1)
Time Frame: 1 year
The percentage of study participants in the Zephyr Valve EBV (Endobronchial Valves) treatment arm meeting the clinically significant threshold of >15% improved forced expiratory volume in one second (FEV1), obtained immediately following bronchodilator therapy, as compared to the percentage in the control arm at 1 year post-procedure.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FEV1 Post-bronchodilator Absolute Change
Time Frame: 1 year
Difference between study arms in absolute change from baseline for post-bronchodilator FEV1 score at 1 year (value at 1 year minus value at baseline).
1 year
St. George's Respiratory Questionnaire (SGRQ)
Time Frame: 1 year

Difference between study arms in 'absolute change from baseline' for SGRQ score at 1 year (value at 1 year minus value at baseline).

The St. George's Respiratory Questionnaire measures health status (quality of life) in patients with diseases of airways obstruction. The questionnaire comprises of two parts:

Part I: Symptoms (frequency & severity) Part II: Activities that cause or are limited by breathlessness; Impacts (social functioning, psychological disturbances resulting from airways disease)

A Total score is calculated which summarizes the impact of the disease on overall health status. Scores range from 0 to 100, with higher scores indicating more limitations.
1 year
6-minute Walk Distance
Time Frame: 1 year
Difference between study arms in 'absolute and percentage change from baseline' for 6MWD at 1 year (value at 1 year minus value at baseline).
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pulmonx Corporation

Investigators

  • Principal Investigator: Gerard Criner, MD, Temple University Hospital, Philadelphia, PA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2013

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

April 1, 2023

Study Registration Dates

First Submitted

February 20, 2013

First Submitted That Met QC Criteria

February 20, 2013

First Posted (Estimated)

February 21, 2013

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 600-0012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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