Endobronchial Valve in Patients With Heterogeneous Emphysema

A Multi-center, Prospective, Randomized, Controlled Trial of Endobronchial Valve Therapy vs. Standard of Care in Heterogeneous Emphysema

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease; Emphysema
• Intervention / Treatment: Device: Zephyr endobronchial valve placement

Detailed Description

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
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ELVR with Endobronchial Valves; Patients will have ELVR (Endoscopic Lung Volume Reduction) with Endobronchial Valves (Zephyr valve) inserted into the target lobe of the lung with the aim of complete lobar exclusion.	Device: Zephyr endobronchial valve placement; 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.
NO_INTERVENTION: Standard of Care; Patients will receive optimal drug therapy and medical management according to clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage change in Forced Expiratory Volume in 1 s (FEV1)	At baseline and after 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change in Forced Expiratory Volume in 1 s (FEV1)		At baseline and after 6 months
Comparison of the FEV1 using 15% Percentage change as cut-off for clinically significant change		At baseline and after 3, 6 months
Change in Residual Volume (RV)		At baseline and after 3, 6 months
Change in Total Lung Capacity (TLC)		At baseline and after 3, 6 months
Change in FEV1/FVC ratio		At baseline and after 3, 6 months
Change in St George's Respiratory Questionnaire		At baseline and after 3, 6 months
Change in 6-Min Walk Test		At baseline and after 3, 6 months
Change in BODE index		At baseline and after 3, 6 months
Change in mMRC score		At baseline and after 3, 6 months
Adverse Events and Serious Adverse Events	AEs: Type, incidence, severity, seriousness and relationship to study medications of adverse events (AE) (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE 4.0]	At each visits

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (ANTICIPATED): December 1, 2017
• Study Completion (ANTICIPATED): July 1, 2018

Study Registration Dates

• First Submitted: June 29, 2016
• First Submitted That Met QC Criteria: June 30, 2016
• First Posted (ESTIMATE): July 6, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): July 6, 2016
• Last Update Submitted That Met QC Criteria: June 30, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Endobronchial Valve
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: S2016-026-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Because of personal privacy, the research-related individual participant data do not intend for public sharing.