Chronic Obstructive Pulmonary Disease, Emphysema
Conditions
Keywords
Endobronchial Valve
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.
Interventions
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.
Sponsors
Chinese PLA General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in Forced Expiratory Volume in 1 s (FEV1) | At baseline and after 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 \[CTCAE 4.0\] |
| Change in FEV1/FVC ratio | At baseline and after 3, 6 months | — |
Countries
China
Outcome results
None listed