Respiratory Trials·org

COPD · Lung volume reduction

LIBERATE randomised trial

Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema

LIBERATE trial design and results
Design Multicentre randomised controlled trial
Treatment Zephyr endobronchial valves plus medical management
Control Medical management alone
Population 190 patients with heterogeneous emphysema and little or no collateral ventilation in the target lobe
Follow-up 12 months
Primary endpoint Proportion with an FEV1 improvement of at least 15% at 12 months
Result Zephyr valves produced clinically meaningful benefits in lung function, exercise tolerance, dyspnoea and quality of life sustained to at least 12 months, with an acceptable safety profile in patients with little or no collateral ventilation in the target lobe.
Secondary endpoints Six-minute walk distance, St George's Respiratory Questionnaire, dyspnoea score, pneumothorax

Zephyr EBV provides clinically meaningful benefits in lung function, exercise tolerance, dyspnea, and quality of life out to at least 12 months, with an acceptable safety profile in patients with little or no collateral ventilation in the target lobe.

The trial authors, in the published abstract

How it has aged

Achieves bronchoscopically what NETT achieved surgically, in a comparable phenotype and without a thoracotomy. The selection criterion is absolute: valves only work when the target lobe has no collateral ventilation, which must be demonstrated before the procedure. Pneumothorax is the characteristic complication and occurs in roughly a quarter of patients.

Publications

A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (LIBERATE)

Criner GJ, Sue R, Wright S, et al. 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.

  • Clinically meaningful gains in FEV1, exercise tolerance, dyspnoea and quality of life at 12 months
  • Benefit confined to target lobes without collateral ventilation
  • Acceptable safety profile, with pneumothorax the characteristic complication