a trial on the effects of bronchoscopic lung volume reduction in severe emphysema.

Conditions: Emphysema

Summary: rationale: the published clinical trials investigating the bronchoscopic lung volume reduction, showing important patient-related improvements in efficacy, led to the acknowledgement of the treatment in the gold-copd2017 guidelines. interaction with pulmonary rehabilitation, impact on patient-reported outcomes, physical activity, and extrapulmonary consequences are all topics to gain more insight in. this importantly, to further develop and optimize this innovative and personalized therapy. objective: to study in detail the impact and optimal timing of pulmonary rehabilitation (pr) on exercise physiology and patient-reported outcomes and the impact of the bronchoscopic lung volume reduction treatment using endobronchial valves (ebv) on cardiopulmonary function, metabolism and changes in body composition. study design: this study is a randomized controlled trial with 3 study-arms. group 1 will first follow a pr program and afterwards undergo the ebv treatment. group 2 will first undergo the ebv treatment and approximately 8 weeks later will follow a pr program. group 3 will only undergo the ebv treatment (and can choose to follow a pr program after completing the 6 month fu visit). study population: the study population exist of patients with severe emphysema who undergo a bronchoscopic lung volume reduction treatment using one-way valves. intervention: most patients will undergo a bronchoscopic lung volume reduction treatment using endobronchial valves and a pulmonary rehabilitation program. one group of patient will under a bronchoscopic lung volume reduction treatment using endobronchial valves and can choose whether they also want to follow a pulmonary rehabilitation program afterwards. main study parameters: the main study parameter is the difference in change in endurance time measured by an endurance cycle test between the ebv treatment group and the bronchoscopic lung volume reduction + rehabilitation group (ebv+pr).

rationale: the published clinical trials investigating the bronchoscopic lung volume reduction, showing important patient-related improvements in efficacy, led to the acknowledgement of the treatment in the gold-copd2017 guidelines. interaction with pulmonary rehabilitation, impact on patient-reported outcomes, physical activity, and extrapulmonary consequences are all topics to gain more insight in. this importantly, to further develop and optimize this innovative and personalized therapy. objective: to study in detail the impact and optimal timing of pulmonary rehabilitation (pr) on exercise physiology and patient-reported outcomes and the impact of the bronchoscopic lung volume reduction treatment using endobronchial valves (ebv) on cardiopulmonary function, metabolism and changes in body composition. study design: this study is a randomized controlled trial with 3 study-arms. group 1 will first follow a pr program and afterwards undergo the ebv treatment. group 2 will first undergo the ebv treatment and approximately 8 weeks later will follow a pr program. group 3 will only undergo the ebv treatment (and can choose to follow a pr program after completing the 6 month fu visit). study population: the study population exist of patients with severe emphysema who undergo a bronchoscopic lung volume reduction treatment using one-way valves. intervention: most patients will undergo a bronchoscopic lung volume reduction treatment using endobronchial valves and a pulmonary rehabilitation program. one group of patient will under a bronchoscopic lung volume reduction treatment using endobronchial valves and can choose whether they also want to follow a pulmonary rehabilitation program afterwards. main study parameters: the main study parameter is the difference in change in endurance time measured by an endurance cycle test between the ebv treatment group and the bronchoscopic lung volume reduction + rehabilitation group (ebv+pr). nature and extent of the burden and risks associated with participation, benefit and group relatedness: this study has no major risks for the participating patients. the patients will be exposed to additional exercise capacity and physical activity measurements, 3 additional questionnaires, a ct scan of the quadriceps muscle, a dexa scan and peripheral blood collection. furthermore, a subgroup of patients will be exposed to a cardiac mri or muscle and fat biopsies. patient can directly benefit from the ebv treatment and the pulmonary rehabilitation program. indirect benefit might be achieved, because, at a group level the investigators will learn more about this novel treatment for our severe emphysema patients and will be able to further optimize this treatment.

Eligibility criteria:
inclusion criteria: * copd. * fev1 ≤45%pred and fev1/fvc \<70%. * tlc \>100%pred and rv\>175%pred. * cat ≥18. * \>50% emphysema destruction @-910hu. * \>95% complete major fissure measured by quantitative ct analysis. * non-smoking \>6 months. * signed informed consent. exclusion criteria: * paco2\>8.0 kpa, or pao2\<6.0kpa. * 6-minute walk test \<160m. * significant chronic bronchitis, bronchiectasis, or other infectious lung disease. * 3 of more hospitalizations due to pulmonary infection within last 12 months before baseline assessments * previous lobectomy, lvrs, or lung transplantation. * lvef\ 50mmhg. * anticoagulant therapy which cannot be weaned off prior to procedure. * patient is significantly immunodeficient. * involved in other pulmonary drug studies within 30 days prior to this study. * pulmonary nodule which requires intervention * any disease or condition that interferes with completion of initial or follow-up assessments