Clinical trial NCT02823223: Endobronchial Valve in Patients With Heterogeneous Emphysema
Official title: A Multi-center, Prospective, Randomized, Controlled Trial of Endobronchial Valve Therapy vs. Standard of Care in Heterogeneous Emphysema
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Emphysema
Keywords: Endobronchial Valve
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 72
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage change in Forced Expiratory Volume in 1 s (FEV1)
timeFrame: At baseline and after 3 months
Secondary outcomes:
measure: Percentage change in Forced Expiratory Volume in 1 s (FEV1)
timeFrame: At baseline and after 6 months
measure: Comparison of the FEV1 using 15% Percentage change as cut-off for clinically significant change
timeFrame: At baseline and after 3, 6 months
measure: Change in Residual Volume (RV)
timeFrame: At baseline and after 3, 6 months
measure: Change in Total Lung Capacity (TLC)
timeFrame: At baseline and after 3, 6 months
measure: Change in FEV1/FVC ratio
timeFrame: At baseline and after 3, 6 months
measure: Change in St George's Respiratory Questionnaire
timeFrame: At baseline and after 3, 6 months
measure: Change in 6-Min Walk Test
timeFrame: At baseline and after 3, 6 months
measure: Change in BODE index
timeFrame: At baseline and after 3, 6 months
measure: Change in mMRC score
timeFrame: At baseline and after 3, 6 months
measure: Adverse Events and Serious Adverse Events
timeFrame: At each visits
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Liang_an Chen, MD, phD
role: PRINCIPAL_INVESTIGATOR
References: