Endobronchial valve vs. Standard of care in heterogeneous emphysema
Research type
Research Study
Full title
A Multi-center, Prospective, Randomized, Controlled Trial of Endobronchial Valve (EBV) Therapy vs. Standard of Care (SoC) in Heterogeneous Emphysema
IRAS ID
153982
Contact name
Nicola Downer
Sponsor organisation
Pulmonx International Sàrl
Clinicaltrials.gov Identifier
Research summary
Emphysema, which means that parts of the lung are destroyed, is one component of Chronic Obstructive Pulmonary Disease (COPD). Patients with emphysema suffer from chronic shortness of breath, or dyspnoea, limited capacity to exercise and have a poor health related quality of life. Despite the best medical therapy many people with emphysema remain breathless and limited in their daily activities. In emphysema, the lungs do not empty properly when the person breathes out, and this “gas trapping” makes it harder to breathe. If the emphysema is heterogeneous, some parts of the lung are worse than others. The diseased parts may expand, at the expense of the healthier parts of the lung, which are compressed. Placement of endobronchial valves (EBV) stops air getting into the worst affected parts of the lung, and thereby stops them from trapping gas. The valve allow air and liquid to escape from the treated part of the lung. This makes the volume of the lung decrease successively, allowing the healthier parts to expand, which may make the lung as a whole function better. This improves lung function, breathlessness and exercise capacity. In emphysema, sometimes there are abnormal connections (also called collateral ventilation) between different sections of the lung. This will cause air to leak into the lobes from behind the valves and reduce the effect of the valves. Patients with these connections will not be included in this study. This study is designed to compare the results from patients treated with valves with those from patients treated with medical therapy only. Further, this trial will provide an opportunity to evaluate how patients experience the benefit of the treatment (quality of life), as well as health economic aspects of the treatment. The patients will be followed for up to 2 years.
REC name
London - Stanmore Research Ethics Committee
REC reference
14/LO/1090
Date of REC Opinion
26 Aug 2014
REC opinion
Further Information Favourable Opinion