Endobronchial Valve in Patients With Heterogeneous Emphysema

Chinese PLA General Hospital72 enrolled

Overview

To compare the clinical outcomes of Endoscopic Lung Volume Reduction using Pulmonx Zephyr Endobronchial Valve (EBV) vs. Standard of Care (SoC) in the treatment of heterogeneous emphysema patients in a controlled trial design setting.

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 Heterogeneous Emphysema. Patients will be followed up for 6 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease Emphysema

Interventions

Zephyr endobronchial valve placementDEVICE

Patients will have ELVR (Endoscopic Lung Volume Reduction) with Zephyr valve inserted into the target lobe of the lung with the aim of complete lobar exclusion.

Eligibility

Sex: ALLMin age: 35 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Consent form signed * Heterogeneous emphysema on Chest CT Scanner * Intact interlobar fissures adjacent to the target lobe on Chest CT or collateral ventilation negative in the target lobe by Chartis assessment * Post bronchodilator Forced expiratory volume in 1 second (FEV1) \< 50% predicted * Total Lung Capacity \> 100% predicted * Residual Volume \> 150% predicted * PaO2 \> 45mmHg * Post rehabilitation 6 minute walk test \> 140m * No COPD exacerbation for at least 6 weeks * Stopped cigarette smoking for more than 3 months Exclusion Criteria: * Contraindication to bronchoscopy * Tuberculosis, pleural effusion, or clinically significant bronchiectasis * Lung carcinoma or pulmonary nodule on CT scan requiring Chest CT scan follow-up * Active pulmonary infection * Prior lung transplant, LVRS, median sternotomy, bullectomy or lobectomy * Any extrapulmonary diseases compromising survival or evaluation within the protocol (severe cardiac disease, severe renal insufficiency, cancer…) * Inclusion in an other study assessing respiratory treatments * Pregnant or lactating woman

Locations (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Percentage change in Forced Expiratory Volume in 1 s (FEV1)

Time frame: At baseline and after 3 months