Pulmonx® Corp. today announced positive one-year results from the U.S. LIBERATE pivotal trial of the Zephyr® Endobronchial Valve, a minimally-invasive treatment for severe emphysema, an advanced form of chronic obstructive pulmonary disease (COPD).
“The LIBERATE Study definitively proves that Zephyr Valves offer clinically meaningful improvements in three important areas for patients – the ability to breathe better, be more active, and enjoy an improved quality of life,” said the study’s lead investigator, Gerard Criner, MD, FACP, FACCP, Chair and Professor of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University.
He continued, “All primary and secondary endpoints were met, with Zephyr Valve treatment showing significant improvement for patients across multiple measures of breathing and quality of life. The Zephyr Valve also demonstrated an acceptable safety profile given the magnitude of benefit seen in this study.”
The LIBERATE Study results were concurrently published in the American Journal of Respiratory and Critical Care Medicine and presented at the American Thoracic Society (ATS) 2018 International Conference by Dr. Criner.
A copy of the open access article can be viewed here.
LIBERATE is the first international, multicenter, randomized controlled trial to evaluate the effectiveness and safety of the Zephyr Endobronchial Valve out to one year in patients with severe heterogeneous emphysema with little to no collateral ventilation in the target lobe of the lung. The study randomized 190 patients at 24 sites, using a 2:1 randomization to Zephyr Valve treatment or medical management alone. Eligible patients were assessed for collateral ventilation using the Chartis® Pulmonary Assessment System, and only patients with little to no collateral ventilation in the target lobe were randomized.
One year after treatment, almost three times more patients treated with Zephyr Valves achieved the target improvement in lung function (≥15% increase in FEV1) compared to patients on medical management alone. In addition, Zephyr patients were able to do more daily activities, such as walking, doing chores and getting washed, with less shortness of breath than patients on medical management alone.
The most common side effect associated with the procedure was pneumothorax (air leak in the lung), which occurred in approximately one-third of patients. No intervention was required in approximately 20 percent of the incidents; the majority of the rest were addressed with standard medical management. Other side effects that happened less frequently included COPD exacerbation, pneumonia, respiratory failure and death.
Patients treated with Zephyr Valves had a statistically significant reduction in the rate of respiratory failure and a trend towards a reduction in the rate of COPD hospitalizations when compared to patients on medical management alone in the period following treatment to one year of follow-up.
Key outcomes at 12 months included:
- Primary endpoint met:
- Percentage of subjects with FEV1 improvement of ≥15% (a measure of breathing): 47.7% Zephyr Valve versus 16.8% control group (p<0.001).
- Secondary endpoints met – the difference between the Zephyr Valve group and control group favored treated patients by:
- FEV1 (a measure of breathing): 0.106L (p<0.001).
- St. George’s Respiratory Questionnaire score (SGRQ, a measure of quality of life): -7.05 points (p=0.004).
- Six-Minute Walk Distance (6MWD, a measure of exercise capacity): +39.3 meters (p=0.002).
The authors of the study commented that, “Bronchoscopic lung volume reduction with Zephyr EBV (endobronchial valves) is a breakthrough approach for reducing hyperinflation in patients with severe emphysema.” Furthermore, they noted that, “The occurrence of pneumothorax does not negatively impact clinical outcomes.”
Zephyr Valves are designed for emphysema patients who are often short of breath and doing less of the things they want to do despite regular use of COPD medications and/or oxygen. The tiny, one-way valves are placed in target airways of the lungs in a short procedure that does not involve cutting to occlude, or block off, the more diseased areas. This reduces hyperinflation and allows healthier parts of the lungs to take in more air and work more effectively. They are designed to be permanent, but can easily be removed, if necessary.
Over 12,000 patients worldwide have been treated with Zephyr Valves. This treatment option is included in emphysema treatment guidance issued by leading health organizations worldwide, including the Global Initiative for Chronic Obstructive Lung Disease (GOLD) and the UK’s National Institute for Health and Care Excellence (NICE). Zephyr Endobronchial Valves are the only endoscopic emphysema treatment with patient selection tools (Chartis and StratX® Lung Analysis Platform) that can accurately identify patients most likely to benefit from treatment, demonstrating 90 percent accuracy when used in combination.