A Multi-center, Prospective, Randomized, Controlled Single Arm Investigation of Endobronchial Valve (EBV) Therapy vs. Standard of Care (SoC) in Homogeneous Emphysema.

Patients with severe emphysema suffer from severe dyspnea and a poor quality of
life, with no current effective medical treatment. Only for a very small,
highly selective group of COPD patients, very invasive surgical procedures like
lung volume reduction surgery (LVRS) or lungtransplantation are available.
Minimally invasive bronchoscopic lung volume reduction (BLVR) techniques
through the implantation of one-way valves have now been established as a means
of treating the hyperinflation of emphysema for a group of selected
patients.clinical evidence indicates that by achieving lobar occlusion in the
absence of collateral ventilation, significant lung volume reduction can be
obtained with associated good clinical responses. The Chartis Pulmonary
Assessment System which assesses collateral ventilation has shown 75% accuracy
in predicting response. Retrospective analysis from the datasets from both the
US and European VENT studies, where these criteria have been fulfilled,
suggests that a response can be achieved even in subjects who do not have
heterogeneous emphysema. Furthermore, prospective pilot study in subjects with
severe homogeneous emphysema has demonstrated that EBV placement in such
subjects is feasible with an acceptable safety profile (unpublished results).

Primary objective:
To evaluate pulmonary function (FEV1) at 3 months following placement of Zephyr
endobronchial valves in subjects with homogeneous emphysema.

Secondary objectives:
Evaluation of quality of life, exercise capacity, dyspnea incl. BODE, volume
reduction and adverse events at 3 and 6 months following placement of Zephyr
EBV in subjects with homogeneous emphysema.

This is a randomized, multi-centre, controlled study.
Subjects will be followed up for a period of 12 months following endobronchial
valve placement. Assessments will be performed at 3, 6 and 12 months
post-implantation.

Placement of oneway-valves during a bronchoscopy (Bronchoscopic lungvolume
reduction).

The patients that will be included will have to come to our outpatient clinic,
perform pulmonary function testing, a 6 min walking test, HRCT scanning
thoracic x-ray, fill in questionnaires and testing of blood samples and
arterial blood gas. For the actual treatment with bronchoscopy under general
anesthesia the patients will stay two nights in our hospital. For the
follow-up, the patients will visit the hospital (4x), which will include 1 CT
scan and pulmonary function tests, questionnaires and exercise testing (6MWT).
The included patients will have to put large effort in the study, but is in
balance with the expected outcome and very limited compared 'alternative'
treatments like highly invasive surgery: Lung volume reduction surgery or Lung
transplantation. All included patients have a severe limitation of their
activities of daily living. With the development and validation of the use of
the lung volume reduction treatment with the placement of valves, does it seem
possible to give relieve of shortness of breath and improvement in exercise
performance. Furthermore, this technique can be used as a 'bridge' to lung
transplantation in future, or will be the only possible therapeutic tool
available by then. The risks are not bigger than the risks any individual has
for the investigations described. The treatment with the valves and inducing
the significant volume reduction the major risks involved are: Pneumothorax (1
in 10 patients) for which chest drainage is required, transient (1-3 days)
chest pain (1 in 2 patients), transient (1-7 days) and dyspnea (1 in 4
patients).