Endobronchial Valve in Patients With Heterogeneous Emphysema

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Emphysema, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: Zephyr endobronchial valve placement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ELVR with Endobronchial Valves<br>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<br>* 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.<br>|
| No Intervention: Standard of Care<br>Patients will receive optimal drug therapy and medical management according to clinical practice | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endobronchial Valve