Implantation of Endobronchial Valves Versus Intrabronchial Valves in Patients With Severe Heterogeneous Emphysema

Overview

Patients with advanced heterogeneous emphysema experience improvement in clinical outcomes in the same way following either implantation of endobronchial valves or intrabronchial valves.

Full Title of Study: “Endoscopic Lung Volume Reduction by Implantation of Endobronchial Valves (EBV) vs. Intrabronchial Valves (IBV) in Patients With Severe Heterogeneous Emphysema”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 1, 2012

Detailed Description

Patient enrollment and data acquisition is to be carried out on a prospective basis. It is planned to enroll a total of 50 patients with advanced heterogeneous emphysema. After decision to undertake endoscopic lung volume reduction by valve implantation patients will be randomised to two treatment arms. 25 patients receive unilateral IBV treatment or unilateral EBV treatment in each case. All patients will undergo treatment at one study centre in Heidelberg.

Interventions

  • Device: EBV implantation
    • In severe cases of COPD even optimum treatment involving bronchodilatation with drugs, physical training and possibly oxygen therapy is unable to influence exercise capacity and the perception of dyspnoea to a sufficient extent. Given the assumption that the elastic recoil of the small airways can be improved by a reduction in lung volume and pulmonary function overall by more ergonomic breathing mechanics and diaphragm function, various endoscopic procedures for lung volume reduction are available. The most advanced technique is the implantation of valves. The one-way mechanism of these valves allows air to be expelled during exspiration without any influx of air during inspiration.
  • Device: IBV implantation
    • In severe cases of COPD even optimum treatment involving bronchodilatation with drugs, physical training and possibly oxygen therapy is unable to influence exercise capacity and the perception of dyspnoea to a sufficient extent. Given the assumption that the elastic recoil of the small airways can be improved by a reduction in lung volume and pulmonary function overall by more ergonomic breathing mechanics and diaphragm function, various endoscopic procedures for lung volume reduction are available. The most advanced technique is the implantation of valves. The one-way mechanism of these valves allows air to be expelled during exspiration without any influx of air during inspiration.

Arms, Groups and Cohorts

  • Active Comparator: Endobronchial valves (EBV)
    • Complete occlusion of one emphysematous destroyed lobe by implantation of endobronchial valves
  • Active Comparator: Intrabronchial valves (IBV)
    • Complete occlusion of one emphysematous destroyed lobe by implantation of intrabronchial valves

Clinical Trial Outcome Measures

Primary Measures

  • Improvement in pulmonary function (FEV1 and RV/TLC)
    • Time Frame: 6 months

Secondary Measures

  • Number of severe adverse events
    • Time Frame: 6 months
  • Evaluation of valve migration rate
    • Time Frame: 6 months
  • Average changes in pulmonary function (FEV1, IVC, RV, TLC, RV/TLC)
    • Time Frame: 6 months
  • Average changes in 6-minute-walk-distance
    • Time Frame: 6 months

Participating in This Clinical Trial

Inclusion Criteria

  • pulmonary function: FEV1 < 45 %, RV > 150 %, TLC > 100 % – heterogeneous emphysema Exclusion Criteria:

  • homogeneous emphysema – significant bronchiectasis – severe concomitant diseases – pregnancy

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Heidelberg University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Felix JF Herth, Professor MD – Heidelberg University

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