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. 2017 Feb 23;2017(2):CD012158. doi: 10.1002/14651858.CD012158.pub2

NCT01457833.

Trial name or title Implantation of endobronchial valves versus intrabronchial valves in patients with severe heterogeneous emphysema
Methods Randomized open‐label study. Follow‐up: until 6 months. Estimated enrolment: n = 50
Site: Thoraxklink Heidelberg (Germany)
Participants COPD patients with severe heterogeneous emphysema
Inclusion criteria:

  • pulmonary function: FEV1 < 45 %, RV > 150 %, TLC > 100 %

  • heterogeneous emphysema
Interventions Unilateral endobronchial valves versus intrabronchial valve placement
Outcomes Primary: Improvement in pulmonary function (FEV1 and RV/TLC)
 Secondary:

  • Number of severe adverse events

  • Evaluation of valve migration rate

  • Average changes in pulmonary function (FEV1, IVC, RV, TLC, RV/TLC)

  • Average changes in 6‐minute walk distance
Starting date August 2011
Contact information Principal Investigator: Daniela Gompelmann, MD
Notes NCT01457833