US-based Pulmonx has completed enrolment for its LIBERATE Trial, which is a randomised, controlled, multi-centre study of the Zephyr Endobronchial Valve (EBV) in patients suffering with severe emphysema, a kind of chronic obstructive pulmonary disease (COPD).
Results obtained from the LIBERATE Trial will support approval in order to use the device in the US.
Small, minimally-invasive, one-way valves, Zephyr EBVs are placed in select airways of the lungs to occlude diseased regions and cut down lung hyperinflation. The remaining healthier regions then function more efficiently, enabling better breathing and an improved quality of life for patients.
The LIBERATE Trial saw enrolment of 190 patients at 24 centres to evaluate the safety and effectiveness of the Zephyr EBV versus optimal medical management, with patients randomized 2:1 Zephyr EBV versus control.
The primary outcome to be analysed at one year is Forced Expiratory Volume in one second (FEV1, an objective measure of breathing function). Secondary outcomes are volume reduction of the treated lobe of the lung, the six minute walk distance (6MWD, a measure of exercise tolerance) and the St. George’s Respiratory Questionnaire (SGRQ, a measure of quality of life).
Pulmonx CEO Glen French said: “The Zephyr EBV is the most studied endoscopic lung volume reduction device globally and is considered first-line therapy by leading physicians outside of the US.
“Completing enrolment in this important trial moves us one step closer to making this proven treatment available to US patients who have few options today.”
Three randomised controlled trials, BeLieVeR-HIFi, STELVIO and IMPACT, of the Zephyr EBV conducted outside of the US offer evidence supporting the device’s ability to improve lung function, exercise tolerance and quality of life in patients with no collateral ventilation, as analysed with the Chartis System.
Published clinical data also indicates sustained benefits to patients including potential survival benefits at five and 10 years post-treatment, thereby showing a possible slowing in disease progression.
Over 50% of severe emphysema patients have no collateral ventilation in one or more target lobes of the lung, indicating a large potential market for the Zephyr EBV treatment.
In the last 10 years, over 40,000 Zephyr EBVs have been implanted globally in more than 12,000 patients.