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The LIBERATE Study

The LIBERATE Study

The LIBERATE Study

Product catalog summary
Study Design and Objective: The LIBERATE study is a multicenter, multinational randomized controlled trial aimed at evaluating the effectiveness and safety of Zephyr® Endobronchial Valves (EBV) in patients with heterogeneous emphysema and little or no collateral ventilation over a period of 12 months.
Methods and Endpoints: The study involved 190 subjects with hyperinflation, randomized in a 2:1 ratio (128 received Zephyr EBV and 62 received standard of care (SoC)). The primary endpoint was the change in FEV1, with secondary endpoints including changes in the St. George’s Respiratory Questionnaire (SGRQ) scores and Six-Minute Walk Distance (6MWD).
Results: The EBV group showed significant improvements in lung function, exercise tolerance, dyspnea, and quality of life compared to the SoC group. Specifically, 47.7% of EBV subjects achieved a ≥15% improvement in FEV1 compared to 16.8% in the SoC group (p<0.001). The EBV group also demonstrated significant improvements in SGRQ and 6MWD scores.
Safety: The study reported an increased rate of serious adverse events (SAEs) in the EBV group within the first 45 days post-procedure, including a 26.6% incidence of pneumothorax. However, the long-term SAE rate (46 days to 12 months) was reduced in the EBV group compared to SoC. Notably, 5 out of 8 subjects experiencing pneumothorax had undergone secondary bronchoscopy for valve replacement or removal.
Conclusion: Zephyr® Endobronchial Valve treatment provides clinically meaningful benefits in selected patients with little or no collateral ventilation, offering improvements in lung function and quality of life over standard medical therapy, with a manageable safety profile.
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Catalog excerpts

The LIBERATE Study-1

Published in THE AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE The LIBERATE Study A multicenter, multinational randomized controlled trial of Zephyr® Endobronchial Valves in patients with heterogenous emphysema and little or no collateral ventilation ts are comparable to those “ The benefiin post-procedure morbidity.seen with LVRS but with a reduction ” Criner G et al Am J Resp Crit Care Med 2018, in press METHODS & ENDPOINTS • First multicenter RCT to evaluate effectiveness and safety of Zephyr® Endobronchial Valves in patients with little or no collateral ventilation (CV) out to 12 months. • 190 subjects with hyperinflation (RV, 225% pred.; FEV1, 27% pred.; DLCO, 34% pred.) randomized 2:1 (128 Zephyr EBV: 62 SoC). STUDY DESIGN 909 Subjects consented - 2 Withdrew consent - 4 Died - 1 Excluded for medical reasons 121 Active subjects at 45 days 719 Subjects excluded • 13 Withdrew consent • 706 Screen failures - 65 No eligible CV-lobe - 280 Heterogeneity /destruction score - 156 PFTs/lung volumes - 145 Medical history, age, BMI, smoking history - 49 Blood chemistry - 11 Other 62 Active subjects at 45 days - 1 Died - 2 Excluded for medical reasons - 1 Died 120 Active subjects at 6 months 59 Active subjects at 6 months 59 Active subjects at 12 months - 1 Unwiling to return for follow-up visits 119 Active subjects at 12 months - 2 Missed 12-month visit - 2 Not evaluated because of ongoing AEs – both subsequently died in Year 2 SOURCE: Criner G et al Am J Resp Crit Care Med 2018, in press 43 Active crossover subjects - 8 Pending crossover procedures - 7 Excluded for medical

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The LIBERATE Study-2

Primary Endpoint Responder Analysis Other Responder Analysis Percent of Subjects with FEV1 Change of ≥ 15% Proportion of Patients Achieving MCID EBV group from Baseline Control group from Baseline Six-Minute Walk Distance (meters) EBV group from Baseline Between-group difference Control group from Baseline EBV group from Baseline Between-group difference Control group from Baseline Change in SGRQ scope (points) St. George’s Resp Questionnaire (points) EBV group from Baseline Between-group difference Control group from Baseline Safety: Pulmonary Serious Adverse Events Occurring in at Least 3.0%...

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