Clinical Trial: Long Term Follow up Investigation of Endobronchial Valves in Emphysema

Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational

Official Title: Long Term Follow up Investigation of Endobronchial Valves in Emphysema

Brief Summary: This is an observational prospective single arm multicentre study to observe the effect over 5 years of Zephyr endobronchial valve therapy for emphysema.

Detailed Summary: Primary objective is pulmonary function as assessed by FEV1 and secondary objectives are health related quality of life as assessed by the modified MRC dyspnea score and by the COPD assessment test, and survival at five years. 2000 patients will be enrolled in the study from approximately 200 referring centres in Germany. Patients will be followed up at 3, 6, and 12 months, and then yearly up to 5 years. The study will observe normal clinical practice. No investigations beyond those performed in normal clinical practice will be required with the exception of two short questionnaires. Patients will only be enrolled in the study if they have provided informed written consent for their anonymised data to be used in the study. Zephyr Endobronchial Valve has CE mark and is fully reimbursed in Germany and will not be provided by the sponsor for this study but will be obtained through normal commercial channels in accordance with normal clinical practice.
Sponsor: Pulmonx International Sàrl

Current Primary Outcome: FEV1 [ Time Frame: 2 years ]

Relative (percentage) change from baseline at 2 years (24 months) of the Forced Expiratory Volume in one second (FEV1)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Modified Medical Research Council (mMRC) Questionnaire [ Time Frame: 5 years ]
    Absolute and relative change from baseline at each visit over the 5 year period of the Modified Medical Research Council (mMRC) Score
  • COPD Assessment Test (CAT) [ Time Frame: 5 years ]
    Absolute and relative change from baseline at each visit over the 5-year period for the COPD Assessment Test (CAT)
  • Survival over 5 years [ Time Frame: 5 years ]
    Survival status over the 5 year study period


Original Secondary Outcome: QOL [ Time Frame: 5 years ]

Relative (percentage) change from baseline at each visit over the 5 year period of the Forced Expiratory Volume in one second (FEV1).

Absolute and relative change from baseline at each visit over the 5 year period of the Modified Medical Research Council Dyspnoea Score (mMRC) Absolute and relative change from baseline at each visit over the 5 year period of the COPD Assessment Test (CAT) Survival at 5 years Safety during the procedural window (adverse events)



Information By: Pulmonx, Inc.

Dates:
Date Received: April 17, 2012
Date Started: July 2012
Date Completion: December 2020
Last Updated: April 6, 2017
Last Verified: April 2017