Endobronchial Valve in Patients With Heterogeneous Emphysema

Chinese PLA General Hospital (301 Hospital)

Status: Unknown

Conditions: Chronic Obstructive Pulmonary Disease; Emphysema

Treatments: Device: Zephyr endobronchial valve placement

Study type: Interventional

Funder types: Other

Identifiers

NCT02823223

S2016-026-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

ELVR with Endobronchial Valves

Experimental group

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.

Treatment:

Device: Zephyr endobronchial valve placement

Standard of Care

No Intervention group

Description:

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