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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02823223
Other study ID # S2016-026-01
Secondary ID
Status Active, not recruiting
Phase N/A
First received June 29, 2016
Last updated June 30, 2016
Start date June 2016
Est. completion date July 2018

Study information

Verified date June 2016
Source Chinese PLA General Hospital
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 72
Est. completion date July 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Both
Age group 35 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
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.

Locations

Country Name City State
China Chinese PLA General Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage change in Forced Expiratory Volume in 1 s (FEV1) At baseline and after 3 months No
Secondary Percentage change in Forced Expiratory Volume in 1 s (FEV1) At baseline and after 6 months No
Secondary Comparison of the FEV1 using 15% Percentage change as cut-off for clinically significant change At baseline and after 3, 6 months No
Secondary Change in Residual Volume (RV) At baseline and after 3, 6 months No
Secondary Change in Total Lung Capacity (TLC) At baseline and after 3, 6 months No
Secondary Change in FEV1/FVC ratio At baseline and after 3, 6 months No
Secondary Change in St George's Respiratory Questionnaire At baseline and after 3, 6 months No
Secondary Change in 6-Min Walk Test At baseline and after 3, 6 months No
Secondary Change in BODE index At baseline and after 3, 6 months No
Secondary Change in mMRC score At baseline and after 3, 6 months No
Secondary 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 Yes
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