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

Pulmonx

Status: Completed

Conditions: Emphysema

Treatments: Other: Optimal Medical Management; Device: EBV

Study type: Interventional

Funder types: Industry

Identifiers

NCT01796392

600-0012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 190 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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190 participants in 2 patient groups

EBV and Optimal Medical Management

Experimental group

Description:

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.

Treatment:

Device: EBV

Optimal Medical Management

Other group

Description:

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

Treatment:

Other: Optimal Medical Management