Background: Therapeutic options for patients with severe emphysema remain limited. In selected patients, lung volume reduction surgery has been shown to improve pulmonary function, exercise capacity, quality of life and also survival. The technique of inserting one-way valves endoscopically into the airways supplying the most affected areas of lung provides the possibility of achieving similar results to surgery (i.e. volume reduction) in a less invasive way, which is also reversible, since the valves can be removed at any time. This technique has been shown to be safe. The aim of this study is to evaluate the efficacy of this technique compared to optimal medical therapy in patients with heterogeneous emphysema defined according to radiological criteria.
Methods: A prospective, international, multicentre (20 centres) randomised trial is underway to establish the efficacy and safety of endobronchial valve placement in this patient group. This study will enrol 270 patients and be analysed on an intention to treat basis. Patients are randomised either to valve insertion or optimal medical treatment alone in a ratio of 2 to 1. Follow up will be ensured for at least one year.
Expected results: The two principal outcome measures will be improvement at six months in FEV1 and in six minute walk distance. The safety of the technique will be evaluated over the same period. Details of the study are available online for patients and their physicians at www.euroemphysema.com.