Endobronchial Valve in Patients With Heterogeneous Emphysema

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02823223
• Other study ID #: S2016-026-01
• 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

• Chronic Obstructive Pulmonary Disease
• Emphysema
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Emphysema

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