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

Not Applicable

Completed

Conditions: Emphysema

Interventions: Device: EBV
Other: Optimal Medical Management

Registration Number: NCT01796392

Lead Sponsor: Pulmonx Corporation

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 190

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EBV and Optimal Medical Management	EBV	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.
Optimal Medical Management	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.

Primary Outcome Measures

Name	Time	Method
Forced Expiratory Volume in 1-second (FEV1)	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.

Secondary Outcome Measures

Name	Time	Method
FEV1 Post-bronchodilator Absolute Change	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).
St. George's Respiratory Questionnaire (SGRQ)	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.
6-minute Walk Distance	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).

Trial Locations

Locations (23): University of Southern California
🇺🇸
Los Angeles, California, United States
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Temple University Hospital
🇺🇸
Philadelphia, Pennsylvania, United States
University of California, San Francisco
🇺🇸
San Francisco, California, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
Orlando Health
🇺🇸
Orlando, Florida, United States
Beth Israel Deaconess Medical Center
🇺🇸
Boston, Massachusetts, United States
University Medical Center Groningen
🇳🇱
Groningen, Netherlands
El Camino Hospital
🇺🇸
Mountain View, California, United States
Stanford University
🇺🇸
Stanford, California, United States
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
🇺🇸
Torrance, California, United States
University of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States
University Hospital Llandough and University Hospital of Wales
🇬🇧
Cardiff, United Kingdom
Houston Methodist Hospital
🇺🇸
Houston, Texas, United States
Hospital de Clinicas Porto Alegre
🇧🇷
Porto Alegre, RS, Brazil
INCOR - Hospital das Clinicas de Faculdade de Medicine da USP
🇧🇷
São Paulo, SP, Brazil
Bristol Royal Infirmary
🇬🇧
Bristol, United Kingdom
Royal Brompton & Harefield NHS Foundation Trust
🇬🇧
London, United Kingdom
The University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
University of California at Davis Medical Center
🇺🇸
Sacramento, California, United States
Arizona Pulmonary Specialists
🇺🇸
Phoenix, Arizona, United States
University of Louisville Research Foundation
🇺🇸
Louisville, Kentucky, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States