Improving Patient Outcomes by Selective Implantation of the Zephyr EBV - Study

Not Applicable

Completed

Conditions: Endoscopic Lung Volume Reduction With Endobronchial Valve
COPD Patients With Homogeneous Emphysema

Interventions: Device: Endobronchial Valve

Registration Number: NCT02025205

Lead Sponsor: Pulmonx International Sàrl

Brief Summary: The aim of this prospective, randomized, controlled, one-way crossover study is to assess and compare the efficacy of the Zephyr endobronchial valves vs. Standard of Care (SoC) in patients suffering from COPD with Homogeneous Emphysema. Patients will be followed up for 12 months after randomization. Patients in the SoC arm will crossover to the EBV treatment arm after the 6-month visit and will be followed up for 6 additional months.The primary objective is the variation of FEV1 between baseline and 3-month follow-up visit. The secondary objectives will evaluate quality of life, exercise capacity, dyspnea (including BODE index) changes, target lobe volume reduction, as well as safety outcomes.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 93

Inclusion Criteria

Homogeneous emphysema
15% ≤ FEV1 ≤ 45% predicted
TLC > 100% predicted
RV ≥ 200% predicted
6MWT ≥ 150 m
Non-smoker > 8 weeks prior to study entry
Absence of Collateral Ventilation in the target lobe

Exclusion Criteria

Active pulmonary infection
More than 3 exacerbations with hospitalizations over the past 12 months
Pulmonary hypertension (sPAP > 45 mmHg)
MI or other relevant CV events in the past 6 months
Alpha-1 antitrypsin deficiency
Bronchiectasis
Prior LVR or LVRS procedure
> 20% difference in perfusion between right and left lung
Hypercapnia (paCO2 > 55 mmHg
Asthma
Use of more than 25 mg/day prednisolone or equivalent
Severe bullous emphysema
Systemic or malignant disease with high death probability within 12 months

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ELVR with Endobronchial Valves	Endobronchial Valve	Endoscopic Lung Volume Reduction with Zephyr Endobronchial Valve

Primary Outcome Measures

Name	Time	Method
Percentage Change in Forced Expiratory Volume in 1 s (FEV1) (ITT Population)	At baseline and after 3 months	Percentage change in FEV1 at 3 months relative to Baseline in the EBV group, compared to the SoC group.

Secondary Outcome Measures

Name	Time	Method
Percent Change in Target Lobe Volume for EBV Group (ITT Population)	At baseline and after 3 months	Target Lobe Volume Reduction (TLVR) was evaluated by quantitative analysis of HRCT scans at Baseline and at 3-months post-valve placement to measure the target lobe volume.
Percent of Subjects in the EBV Group With a Target Lobe Volume Reduction (TLVR) of ≥ 350ml at 3 Months	At baseline and after 3 months	The threshold of TLVR ≥350 mL was used to determine the proportion of subjects that achieved this amount of TLVR in the EBV group.
Percent Change in Residual Volume (RV) at 3 Months	At baseline and after 3 months	Mean percent change in Residual Volume relative to Baseline at 3 months between the EBV and SoC groups
Absolute Change in Target Lobe Volume for EBV Group (ITT Population)	At baseline and after 3 months	Target Lobe Volume Reduction (TLVR) was evaluated by quantitative analysis of HRCT scans at Baseline and at 3-months post-valve placement to measure the target lobe volume.
Absolute Change in FEV1 (L) Post Bronchodilator at 3 Months	At baseline and after 3 months	The mean absolute change in FEV1(L) relative to Baseline at 3 months between the EBV and SoC groups
Absolute Change in FEV1 (% Predicted) Post Bronchodilator at 3 Months	At baseline and after 3 months	The mean absolute change in FEV1(% Predicted) relative to Baseline at 3 months between the EBV and SoC groups
Absolute Change in Residual Volume (RV) at 3 Months	At baseline and after 3 months	Mean absolute change in Residual Volume relative to Baseline at 3 months between the EBV and SoC groups
Percent Predicted Change in Residual Volume at 3 Months	At baseline and after 3 months	Percent predicted change in RV relative to Baseline at 3 months between the EBV and SoC groups
Absolute Change in Six-Minute Walk Distance at 3 Months	At baseline and after 3 months	Mean absolute change in the 6MWD from Baseline to 3 months in the EBV group compared to the SOC
Percent Change in Six-Minute Walk Distance at 3 Months	At baseline and after 3 months	Mean percent change in the 6MWD from Baseline to 3 months in the EBV group compared to the SOC
Absolute Change in the SGRQ Total Score From Baseline to 3 Months	At baseline and after 3 months	Mean absolute change in the St. George's Respiratory Questionnaire Total Score from Baseline to 3 months in the EBV group compared to the SoC group. Scores range from 0 to 100, with higher scores indicating more limitations.
Percent Change (%) in the SGRQ Total Score From Baseline to 3 Months	At baseline and after 3 months	Mean percent change in the SGRQ Total Score from Baseline to 3 months in the EBV group compared to the SoC group
Absolute Change in the mMRC Dyspnea Score From Baseline to 3 Months	At baseline and after 3 months	Mean absolute change in the Modified Medical Research Council (mMRC) Dyspnea Score from Baseline to 3 months in the EBV group compared to the SoC group. The mMRC (Modified Medical Research Council) stratifies severity of dyspnea in respiratory diseases. The severity of dyspnea is rated on a scale of 0 to 4, with higher scores indicating more limitations.
Percent Change (%) in the mMRC Dyspnea Score From Baseline to 3 Months	At baseline and after 3 months	Mean percent change in the mMRC Dyspnea Score from Baseline to 3 months in the EBV group compared to the SoC group. The mMRC (Modified Medical Research Council) stratifies severity of dyspnea in respiratory diseases. The severity of dyspnea is rated on a scale of 0 to 4, with higher scores indicating more limitations.
Absolute Change in the CAT Total Score From Baseline to 3 Months	At baseline and after 3 months	Mean absolute change in the COPD Assessment Test (CAT) Total Score from Baseline to 3 months in the EBV group compared to the SoC group. The COPD Assessment Test (CAT) is an eight-item questionnaire designed to quantify the impact of COPD symptoms on the health status of patients. The CAT provides a score of 0-40 to indicate the impact of disease.
Percent Change (%) in CAT Total Score From Baseline to 3 Months	At baseline and after 3 months	The COPD Assessment Test (CAT) is an eight-item questionnaire designed to quantify the impact of COPD symptoms on the health status of patients. The CAT provides a score of 0-40 to indicate the impact of disease. Higher scores denote a more severe impact of COPD on a patient's life.
Absolute Change in EQ-5D Summary Index From Baseline to 3 Months	At baseline and after 3 months	Mean absolute change in the EQ-5D Summary Index from Baseline to 3 months in the EBV group compared to the SoC group. EQ-5D is a standardized instrument to measure health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ VAS. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D health states may be converted into a single summary index by applying a formula that attaches weights to each of the levels in each dimension. The maximum score of 1 indicates the best health state, while 0 indicates the worst health state.
Percent Change (%) in EQ-5D Summary Index From Baseline to 3 Months	At baseline and after 3 months	Mean percent change in EQ-5D Summary Index from Baseline to 3 months in the EBV group compared to the SoC group.
Absolute Change in EQ-5D VAS (Health State Today) Score From Baseline to 3 Months	At baseline and after 3 months	Mean absolute change in the EQ-5D VAS (Health State Today) Score from Baseline to 3 months in the EBV group compared to the SoC group. Scores range from 0 to 100, with higher scores indicating better outcome.

Trial Locations

Locations (8): Ludwig-Boltzmann-Institut für COPD und Pneumologische Epidemiologie
🇦🇹
Vienna, Austria
Department of pulmonary dieases, University Medical Center
🇳🇱
Groningen, Netherlands
Klinikum Nürnberg Nord
🇩🇪
Nürnberg, Germany
Thoraxklinik am Universitäts klinikum Heidelberg
🇩🇪
Heidelberg, Germany
Lungenklinik Hemer
🇩🇪
Hemer, Germany
Charité Campus Virchow-Klinikum
🇩🇪
Berlin, Germany
Lungenabteilung Thoraxzentrum Hamburg
🇩🇪
Hamburg, Germany
Ruhrlandklinik, Westdeutsches Lungenzentrum
🇩🇪
Essen, Germany