A Trial on the Effects of Bronchoscopic Lung Volume Reduction in Severe Emphysema.
Condition: Emphysema
MeSH terms: Pulmonary Emphysema; Emphysema
Study type: Interventional

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).
    

Detailed description: 
      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.
    

Intervention name(s): Pulmonary rehabilitation; EBV treatment
Intervention type(s): Behavioral; Device
Intervention description(s): Following a PR program; Bronchoscopic lung volume reduction using endobronchial valves (EBV)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment