Overview

This trial is active, not recruiting.

Condition emphysema
Treatments ebv, optimal medical management
Sponsor Pulmonx, Inc.
Start date July 2013
End date September 2017
Trial size 190 participants
Trial identifier NCT01796392, 600-0012

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(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.
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)
This study arm will receive maximal medical management, including smoking cessation program support if necessary, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
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.

Primary Outcomes

Measure
Forced expiratory volume in 1-second (FEV1)
time frame: 1 year

Secondary Outcomes

Measure
Volumetric reduction of the treated area of the lung
time frame: 1 year
St. George's Respiratory Questionnaire (SGRQ)
time frame: 1 year
6-minute walk distance
time frame: 1 year

Eligibility Criteria

Male or female participants from 40 years up to 75 years old.

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 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

Additional Information

Official title Lung Function Improvement After Bronchoscopic Lung Volume Reduction With Pulmonx Endobronchial Valves Used in Treatment of Emphysema
Principal investigator Gerard Criner, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Pulmonx, Inc..