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Endobronchial Valve in Patients With Heterogeneous Emphysema

Primary Purpose

Chronic Obstructive Pulmonary Disease, Emphysema

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Zephyr endobronchial valve placement

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Endobronchial Valve

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Chinese PLA General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ELVR with Endobronchial Valves

Standard of Care

Arm Description

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.

Patients will receive optimal drug therapy and medical management according to clinical practice

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Comparison of the FEV1 using 15% Percentage change as cut-off for clinically significant change

Change in Residual Volume (RV)

Change in Total Lung Capacity (TLC)

Change in FEV1/FVC ratio

Change in St George's Respiratory Questionnaire

Change in 6-Min Walk Test

Change in BODE index

Change in mMRC score

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]

Full Information

NCT ID

NCT02823223

First Posted

June 29, 2016

Last Updated

June 30, 2016

Sponsor

Chinese PLA General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02823223

Brief Title

Endobronchial Valve in Patients With Heterogeneous Emphysema

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Unknown status

Study Start Date

June 2016 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese PLA General Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease, Emphysema

Keywords

Endobronchial Valve

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ELVR with Endobronchial Valves

Arm Type

Experimental

Arm Description

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.

Arm Title

Standard of Care

Arm Type

No Intervention

Arm Description

Patients will receive optimal drug therapy and medical management according to clinical practice

Intervention Type

Device

Intervention Name(s)

Zephyr endobronchial valve placement

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

At baseline and after 3 months

Secondary Outcome Measure Information:

Title

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

Time Frame

At baseline and after 6 months

Title

Comparison of the FEV1 using 15% Percentage change as cut-off for clinically significant change

Time Frame