- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01796392
Pulmonx Endobronchial Valves Used in Treatment of Emphysema (LIBERATE Study) (LIBERATE)
Lung Function Improvement After Bronchoscopic Lung Volume Reduction With Pulmonx Endobronchial Valves Used in Treatment of Emphysema
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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RS
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Porto Alegre, RS, Brazil, 90035-903
- Hospital de Clínicas Porto Alegre
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SP
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São Paulo, SP, Brazil, 05403-000
- INCOR - Hospital das Clinicas de Faculdade de Medicine da USP
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Groningen, Netherlands, 9700
- University Medical Center Groningen
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Bristol, United Kingdom, BS2 8HW
- Bristol Royal Infirmary
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Cardiff, United Kingdom, CF14 4XW
- University Hospital Llandough and University Hospital of Wales
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London, United Kingdom, SW3 6NP
- Royal Brompton & Harefield NHS Foundation Trust
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Alabama
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Birmingham, Alabama, United States, 35249
- The University of Alabama at Birmingham
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Arizona
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Phoenix, Arizona, United States, 85012
- Arizona Pulmonary Specialists
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California
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Los Angeles, California, United States, 90033
- University of Southern California
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Mountain View, California, United States, 94040
- El Camino Hospital
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Sacramento, California, United States, 95817
- University of California at Davis Medical Center
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San Francisco, California, United States, 94143
- University of California, San Francisco
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Stanford, California, United States, 94507
- Stanford University
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Torrance, California, United States, 90502
- Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
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Florida
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Orlando, Florida, United States, 32806
- Orlando Health
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Kentucky
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Louisville, Kentucky, United States, 40202
- University of Louisville Research Foundation
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19140
- Temple University Hospital
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Medical Center
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Texas
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Houston, Texas, United States, 77030
- Houston Methodist Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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 |
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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.
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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.
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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.
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This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Forced Expiratory Volume in 1-second (FEV1)
Time Frame: 1 year
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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.
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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FEV1 Post-bronchodilator Absolute Change
Time Frame: 1 year
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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).
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1 year
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St. George's Respiratory Questionnaire (SGRQ)
Time Frame: 1 year
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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
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6-minute Walk Distance
Time Frame: 1 year
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Difference between study arms in 'absolute and percentage change from baseline' for 6MWD at 1 year (value at 1 year minus value at baseline).
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1 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gerard Criner, MD, Temple University Hospital, Philadelphia, PA
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 600-0012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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