Identifying REsponders and Exploring Mechanisms of ACTION of the Endobronchial Coil Treatment for Emphysema (REACTION)
Rationale: The PneumRx RePneu Lung Volume Reduction Coil (RePneu LVR-coil) is a bronchoscopic lung volume reduction treatment designed to compress the areas of lung parenchyma most damaged by emphysema. The LVRC treatment was found to be feasible, safe and effective in previous studies. However, patient-based outcomes besides quality of life questionnaires are hardly measured after intervention treatments for COPD. Furthermore, the exact underlying physiological mechanism of the LVR-coil treatment is unknown. Another aspect of the treatment which we to date do not fully understand is which group of patients benefit of the treatment and which group of patients do not, this knowing that the responder rate is already about 60%.
Objective: The objectives of the study are to gain more knowledge on 1) the effect of the LVRC treatment on patient-based outcomes like physical activity, 2) the underlying physiological mechanism of the treatment, 3) the predictors of response to the treatment at baseline, and 4) on a targetted treatment number of coils to be placed per lung using lung compliance.
Study design: This study is a non-randomised open label multi-center intervention study.
Study population: The study population exists of adult patients with severe emphysema with no other treatment options left besides surgical procedures.
Intervention: Bilateral bronchoscopic lung volume reduction treatment with RePneu coils.
Main study parameters/endpoints: The main study endpoint is the change in physical activity between baseline and 3 months follow-up after the second treatment. The secondary endpoints are the changes between baseline and 3 months follow-up after the second treatment in: patient reported outcomes of the treatment, dynamic lung hyperinflation, static lung volumes, lung compliance, diaphragm function, lung perfusion, systemic inflammation and small airways function.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The LVR Coil has been designed to be as safe as possible. It was shown that the risks associated with the LVRC system are largely attributable to the bronchoscopic procedure itself rather than to the device per se. Therefore, it appears that the LVRC device itself does not appreciably increase the risk of serious adverse events beyond the risk of undergoing a bronchoscopy procedure or simply having emphysema. Currently, this treatment is not commercially available in the Netherlands and study participants will have to visit the hospital multiple times. Previous studies have shown that the treatment has beneficial effect for the patient, however not all patients respond. Part of this new study is to try to identify which group of patients respond to the treatment and which patients do not. Therefore, it is possible that a patient will not receive any benefits from the treatment.
|Study start date||2014-06-25|