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

NCT01796392 | Completed Results DMC

• 1 other identifier: 600-0012
• Study Type: interventional
• Target: 190
• Locations: 4 countries
• Sites: 23

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.

Conditions

Emphysema

Keywords

emphysema; endobronchial valve; treatments; pulmonary rehabilitation; lung volume reduction

Outcome Measures

Primary Outcomes (1)

• Forced Expiratory Volume in 1-second (FEV1)

  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 Outcomes (3)

• FEV1 Post-bronchodilator Absolute Change

  1 year

• St. George's Respiratory Questionnaire (SGRQ)

  1 year

• 6-minute Walk Distance

  1 year

Study Arms (2)

EBV and Optimal Medical Management

EXPERIMENTAL

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

Optimal Medical Management

OTHER

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

Interventions

EBV DEVICE

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.

EBV and Optimal Medical Management

Optimal Medical Management OTHER

This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.

Optimal Medical Management

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pulmonx Corporation: lead

Study Sites (23)

The University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

Arizona Pulmonary Specialists

Phoenix, Arizona, 85012, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

El Camino Hospital

Mountain View, California, 94040, United States

Location

University of California at Davis Medical Center

Sacramento, California, 95817, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Stanford University

Stanford, California, 94507, United States

Location

Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

Orlando Health

Orlando, Florida, 32806, United States

Location

University of Louisville Research Foundation

Louisville, Kentucky, 40202, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Hospital de Clinicas Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

INCOR - Hospital das Clinicas de Faculdade de Medicine da USP

São Paulo, São Paulo, 05403-000, Brazil

Location

University Medical Center Groningen

Groningen, 9700, Netherlands

Location

Bristol Royal Infirmary

Bristol, BS2 8HW, United Kingdom

Location

University Hospital Llandough and University Hospital of Wales

Cardiff, CF14 4XW, United Kingdom

Location

Royal Brompton & Harefield NHS Foundation Trust

London, SW3 6NP, United Kingdom

Location

Related Publications (3)

• Bakker JT, Hartman JE, Klooster K, Charbonnier JP, Tsiaousis M, Vliegenthart R, Slebos DJ. Endobronchial valve treatment improves chest-CT diaphragm configuration in COPD. Respir Med. 2024 Nov-Dec;234:107856. doi: 10.1016/j.rmed.2024.107856. Epub 2024 Nov 6.

  PMID: 39515624 DERIVED

• Dransfield MT, Garner JL, Bhatt SP, Slebos DJ, Klooster K, Sciurba FC, Shah PL, Marchetti NT, Sue RD, Wright S, Rivas-Perez H, Wiese TA, Wahidi MM, Goulart de Oliveira H, Armstrong B, Radhakrishnan S, Shargill NS, Criner GJ; LIBERATE Study Group:. Effect of Zephyr Endobronchial Valves on Dyspnea, Activity Levels, and Quality of Life at One Year. Results from a Randomized Clinical Trial. Ann Am Thorac Soc. 2020 Jul;17(7):829-838. doi: 10.1513/AnnalsATS.201909-666OC.

  PMID: 32223724 DERIVED

• Criner GJ, Sue R, Wright S, Dransfield M, Rivas-Perez H, Wiese T, Sciurba FC, Shah PL, Wahidi MM, de Oliveira HG, Morrissey B, Cardoso PFG, Hays S, Majid A, Pastis N Jr, Kopas L, Vollenweider M, McFadden PM, Machuzak M, Hsia DW, Sung A, Jarad N, Kornaszewska M, Hazelrigg S, Krishna G, Armstrong B, Shargill NS, Slebos DJ; LIBERATE Study Group. A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (LIBERATE). Am J Respir Crit Care Med. 2018 Nov 1;198(9):1151-1164. doi: 10.1164/rccm.201803-0590OC.

  PMID: 29787288 DERIVED

MeSH Terms

Conditions

Emphysema

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Narinder Shargill
• Organization: Pulmonx Corporation

nshargill@pulmonx.com

650-216-0108

Study Officials

• Gerard Criner, MD

  Temple University Hospital, Philadelphia, PA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2013
• First Posted: February 21, 2013
• Study Start: July 1, 2013
• Primary Completion: September 1, 2017
• Study Completion: April 1, 2023
• Last Updated: June 15, 2023
• Results First Posted: March 5, 2019

Record last verified: 2023-05

Locations

NL (1); BR (2); US (17); GB (3)