The Effect and Mechanism of Bronchoscopic Lung Volume Reduction by Endobronchial Valve in Korean Emphysema Patients
Condition: Pulmonary Emphysema
MeSH terms: Pulmonary Emphysema; Emphysema
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess efficacy of bronchoscopic lung volume reduction in Korean emphysema patients
    

Detailed description: 
      The prevalence of chronic obstructive pulmonary disease (COPD) is high (13.4%). In addition,
      COPD ranked 10th among the causes of death in Korea, and rose to 7th in 2008. Airflow
      limitation of COPD is caused by a mixture of small airway disease (obstructive bronchiolitis)
      and parenchyma destruction (emphysema). Bronchodilator and anti-inflammatory drugs, such as
      corticosteroids are effective to obstructive bronchiolitis. However, these drugs are not
      effective to emphysema.

      Lung volume reduction was devised to remove hyperinflated lung, and to function remaining
      lung. Surgical lung volume reduction showed improving survival in selected emphysema
      patients. However, surgical lung volume reduction have bee performed rarely due to
      significant surgery-related mortality. In this regard, non-surgical lung volume reduction
      methods have been developed. Of them, bronchoscopic lung volume reduction by endobronchial
      one-way valve is mostly used method and showed lower early complications than surgery.

      The bronchoscopic lung volume reduction using endobronchial valve was proved its efficacy and
      safety in several large clinical trials. Although there were procedure-related complications
      such as acute exacerbation of COPD, pneumonia, or hemoptysis, patients receiving
      endobronchial valves showed improved lung functions, exercise capacity and quality of life.
      The endobronchial valves got approved for Conformity to European (CE) Mark in Europe. In
      follow-up study for patients with endobronchial valves, their efficacy and survival of
      patients were dependent on atelectasis induced by valves. Collateral ventilation plays a key
      role in endobronchial valve-induced atelectasis. Therefore, assessment of collateral
      ventilation should be preceded before inserting endobronchial valve.

      Computed tomography (CT) can visualize and characterize morphologic change of lung of
      patients with COPD. Lung perfusion and ventilation CT protocols were developed for
      quantitative assessment of COPD before and after medical treatment. The CT protocols were
      expected to select optimal patients for endobronchial valves and to evaluate their efficacy.

      We attempt to evaluate efficacy of bronchoscopic lung volume reduction using lung perfusion
      and ventilation CT and other outcomes.
    

Intervention name(s): Endobronchial valve
Intervention type(s): Device
Intervention description(s): One-way endobronchial valves are placed in segmental bronchi of the most hyperinflated and least perfused lobe of the emphysematous lungs on computed tomography (CT). Before the procedure, we confirm that the target lobe has no collateral ventilation with other lobes using Chartis® System (Pulmonx, Inc. Redwood City, CA, USA).
Other intervention name(s): - EBV-TS-4.0 (Zephyr® 4.0); - EBV-TS-5.5 (Zephyr® 5.5)
Intervention MeSH terms: Ivermectin; Abamectin
Intervention model: Single Group Assignment
Intervention model description: Bronchoscopioc lung volume reduction by endobronchial valve
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD; Emphysema; Bronchoscopic lung volume reduction; Endobronchial valve