Endobronchial Valve in Patients With Heterogeneous Emphysema

NCT ID: NCT02823223

Last Updated: 2016-07-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2018-07-31

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.

Conditions

Chronic Obstructive Pulmonary Disease; Emphysema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Zephyr endobronchial valve placement

Intervention Type: DEVICE

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.

Standard of Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chen Liang_An

MD,PHD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liang_an Chen, MD, phD

Role: PRINCIPAL_INVESTIGATOR

Chinese PLA General Hospital

Locations

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

S2016-026-01

Identifier Type: -

Identifier Source: org_study_id