Endobronchial Valve in Patients With Heterogeneous Emphysema

Not Applicable

• Conditions: Chronic Obstructive Pulmonary Disease; Emphysema

• Registration Number: NCT02823223
• Lead Sponsor: Chinese PLA General Hospital

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.

Study Timeline

• Status Verified: 2016-06
• Study Start: 2016-06
• Study First Submitted: 2016-06-29
• Study First Submitted QC: 2016-06-30
• Last Update Submitted: 2016-06-30
• Study First Posted: 2016-07-06
• Last Update Posted: 2016-07-06
• Primary Completion: 2017-12
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage change in Forced Expiratory Volume in 1 s (FEV1)	At baseline and after 3 months

Secondary Outcome Measures

Name	Time	Method
Percentage change in Forced Expiratory Volume in 1 s (FEV1)	At baseline and after 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
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 mMRC score	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
Adverse Events and Serious Adverse Events	At each visits	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 \[CTCAE 4.0\]

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China