NCT02823223.

Trial name or title	Endobronchial valve in patients with heterogeneous emphysema
Methods	Randomized open‐label study. Follow‐up: 6 months. Estimated enrolment: n = 72 participants. Sites: Beijing
Participants	Inclusion criteria: 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 one second (FEV1) < 50% predicted Total Lung Capacity > 100% predicted Residual Volume > 150% predicted PaO2 > 45 mmHg Post rehabilitation 6‐minute walk test > 140m No COPD exacerbation for at least 6 weeks Stopped cigarette smoking for more than 3 months
Interventions	Experimental: BLVR with endobronchial valves Participants will have BLVR with endobronchial valves (Zephyr valve) inserted into the target lobe of the lung with the aim of complete lobar exclusion. Control will be standard care: Participants will receive optimal drug therapy and medical management according to clinical practice
Outcomes	Primary: Percentage change in FEV1 at 3 months Secondary: Percentage change in FEV1 at 6 months Comparison of the FEV1 using 15% percentage change as cutoff for clinically significant change Change in Residual Volume (RV) Change in Total Lung Capacity (TLC) Change in FEV1/FVC ratio Change in St George's Respiratory Questionnaire Change in 6‐Minute Walk Test Change in BODE index Change in mMRC score Adverse events and serious adverse events (type, incidence, severity, seriousness and relationship to study medications of adverse events (AEs) graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 4.0))
Starting date	June 2016
Contact information	Liang_an Chen, MD, PhD
Notes	NCT02823223

ATS: American Thoracic Society; BLVR: Bronchoscopic Lung Volume Reduction; BMI: Body Mass Index; CAT: COPD assessment test score; COPD: Chronic obstructive pulmonary disease; CT: computed tomography; ERS: European Respiratory Society; FEV₁: Forced expiratory volume in one second; iBODE: composite score comprising body composition, airway obstruction, dyspnoea and exercise capacity; IBV: Intrabronchial valve; IVC: inspiratory vital capacity; LVRS: Lung volume reduction surgery; mMRC: Modified Medical Research Council (mMRC) Dyspnoea Scale; MRC: Medical Research Council; PFT: Pulmonary Function Test; RV: Residual volume; SAE: Serious adverse event; TLC: Total Lung Capcity; VATS: Video‐assisted thoracoscopic surgery.