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:
|
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:
(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.