Overview

This trial is active, not recruiting.

Conditions chronic obstructive pulmonary disease, emphysema
Treatment zephyr endobronchial valve placement
Sponsor Chinese PLA General Hospital
Start date June 2016
End date December 2017
Trial size 72 participants
Trial identifier NCT02823223, S2016-026-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
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.
(No Intervention)
Patients will receive optimal drug therapy and medical management according to clinical practice

Primary Outcomes

Measure
Percentage change in Forced Expiratory Volume in 1 s (FEV1)
time frame: At baseline and after 3 months

Secondary Outcomes

Measure
Percentage change in Forced Expiratory Volume in 1 s (FEV1)
time frame: At baseline and after 6 months
Comparison of the FEV1 using 15% Percentage change as cut-off for clinically significant change
time frame: At baseline and after 3, 6 months
Change in Residual Volume (RV)
time frame: At baseline and after 3, 6 months
Change in Total Lung Capacity (TLC)
time frame: At baseline and after 3, 6 months
Change in FEV1/FVC ratio
time frame: At baseline and after 3, 6 months
Change in St George's Respiratory Questionnaire
time frame: At baseline and after 3, 6 months
Change in 6-Min Walk Test
time frame: At baseline and after 3, 6 months
Change in BODE index
time frame: At baseline and after 3, 6 months
Change in mMRC score
time frame: At baseline and after 3, 6 months
Adverse Events and Serious Adverse Events
time frame: At each visits

Eligibility Criteria

Male or female participants at least 35 years old.

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

Additional Information

Official title A Multi-center, Prospective, Randomized, Controlled Trial of Endobronchial Valve Therapy vs. Standard of Care in Heterogeneous Emphysema
Principal investigator Liang_an Chen, MD, phD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Chinese PLA General Hospital.