Clinical trial NCT01796392: Pulmonx Endobronchial Valves Used in Treatment of Emphysema (LIBERATE Study)
Official title: Lung Function Improvement After Bronchoscopic Lung Volume Reduction With Pulmonx Endobronchial Valves Used in Treatment of Emphysema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emphysema
Keywords: emphysema
endobronchial valve
treatments
pulmonary rehabilitation
lung volume reduction
Lead sponsor: Pulmonx Corporation
Sponsor class: INDUSTRY
First posted: 2013-02-21
Enrollment: 190
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Forced Expiratory Volume in 1-second (FEV1)
timeFrame: 1 year
Secondary outcomes:
measure: FEV1 Post-bronchodilator Absolute Change
timeFrame: 1 year
measure: St. George's Respiratory Questionnaire (SGRQ)
timeFrame: 1 year
measure: 6-minute Walk Distance
timeFrame: 1 year
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Arizona Pulmonary Specialists
state: Arizona
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Mountain View
country: United States
facility: El Camino Hospital
state: California
city: Sacramento
country: United States
facility: University of California at Davis Medical Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Torrance
country: United States
facility: Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
state: California
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Louisville
country: United States
facility: University of Louisville Research Foundation
state: Kentucky
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas Porto Alegre
state: RS
city: São Paulo
country: Brazil
facility: INCOR - Hospital das Clinicas de Faculdade de Medicine da USP
state: SP
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Bristol
country: United Kingdom
facility: Bristol Royal Infirmary
city: Cardiff
country: United Kingdom
facility: University Hospital Llandough and University Hospital of Wales
city: London
country: United Kingdom
facility: Royal Brompton & Harefield NHS Foundation Trust
Study officials:
affiliation: Temple University Hospital, Philadelphia, PA
name: Gerard Criner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.