Endoscopic Long Volume Reduction by Endobronchial Valves in Belgium (BEVA)

October 23, 2019 updated by: Wim Janssens, KU Leuven
This a single center non-randomised non-sham controlled intervention study evaluating the effectiveness and safety of endoscopic lung volume reduction by endobronchial valves

Study Overview

Detailed Description

The primary objective of the current study is to explore the effect of targeted lobar endobronchial lung volume reduction in symptomatic patients with severe emphysema and absent collateral ventilation, on lung function, exercise capacity and physical activity. As a secondary objective, changes in physical activity as result of a 3 month activity coaching program delivered between 3 to 6 months post intervention will be investigated. Exploratory objectives are to extend insight in the clinical characteristics of responders and non-responders and to address relationships between lung function response, physical functioning and its impact on inflammation, skeletal and cardiac function. Furthermore, comparison of the effects on lung function, exercise capacity, quality of life and physical activity between endoscopic lung volume reduction and surgical lung volume reduction will be made.

The study will also explore if treatment response can be optimised by an intermediate evaluation with CT scan one month after intervention. Endoscopic evaluation and repositioning of the endobronchial valves will be imposed in case no lober atelectasis is visualised.

.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Flanders
      • Leuven, Flanders, Belgium, 3000
        • Recruiting
        • UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 40 - 75 years
  • Confluent or destructive heterogeneous emphysema on CT
  • Smoking cessation for at least 6m (proven by urinary cotinine levels)
  • FEV1 < 60 %predicted, RV > 150 %predicted, TLC > 90 %predicted
  • RV/TLC ratio ≥ 0.55
  • 6MWD < 450 meter
  • mMRC ≥ 2
  • Visual estimation of 70% complete fissure between target lobe and adjacent lobe on CT of referring physician
  • LABA-LAMA bronchodilator therapy as a minimum therapy
  • Able to sign informed consent

Exclusion Criteria:

  • Homogenous emphysema
  • PaCO2 > 60 mmHg with ambient air
  • PaO2 < 45 mmHg with ambient air
  • Previous LVRS, lung transplantation, lobectomy
  • TLCO or FEV1 < 20% predicted
  • Significant pulmonary hypertension (PaPsyst > 50 mm Hg)
  • Heart failure with reduced EF (< 40%)
  • 6MWD < 100 meter
  • BODE index ≥ 7 and eligible for transplantation
  • Active cancer
  • Life expectancy < 3 months
  • Significant lung disease other than COPD/emphysema
  • Unable to comply with study procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: control
standard care in case collateral ventilation is observed (by Chartis) with 3 months physical activity tele coaching between 3 and 6 months post allocation.
3 month physical activity tele coaching intervention consisting of a project tailored smartphone application in combination with a step counter providing direct feedback.
Patients not eligible for endoscopic lung volume reduction (or non responders of this intervention) can be referred for surgical lung volume reduction. With this procedure, the most emphysematous parts of the lungs will be surgically removed.
Experimental: Endobronchial valves
Endobronchial valves in case collateral ventilation is absent (by Chartis) with 3 months physical activity tele coaching between 3 and 6 months post intervention.
3 month physical activity tele coaching intervention consisting of a project tailored smartphone application in combination with a step counter providing direct feedback.
Patients not eligible for endoscopic lung volume reduction (or non responders of this intervention) can be referred for surgical lung volume reduction. With this procedure, the most emphysematous parts of the lungs will be surgically removed.
A ambulatory diagnostic bronchoscopy under general anesthesia will evaluate the presence or absence of collateral ventilation . The targeted lobar airway is temporarily occluded by means of a balloon catheter, which blocks inspiratory flow but allows expiratory flow, in order to assess whether the air flow gradually declines to zero, meaning absence of collateral ventilation. Only in case collateral ventilation is excluded, a therapeutic bronchoscopy will be scheduled to insert the one-directional endobronchial valves in the targeted lobar airways. We will only perform a unilateral intervention during which we will treat one or maximal two lobes at one side.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
response rate of FEV1 at 3 months post intervention
Time Frame: 3 months
proportion of patients with a minimal change of FEV1 > 100 ml
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
response rate on SGRQ at 3 months and 6 months post intervention
Time Frame: 3 months and 6 months post intervention
proportion of patients with a minimal change of -4 points on SGRQ
3 months and 6 months post intervention
response rate on 6 minutes walking distance (6MWD) at 3 months and 6 months post intervention
Time Frame: 3 months and 6 months post intervention
proportion of patients with a minimal improvement of 30 meters on 6MWD
3 months and 6 months post intervention
response rate on residual volume (RV) at 3 months and 6 months post intervention
Time Frame: 3 months and 6 months post intervention
proportion of patients with a minimal reduction of 400 ml on residual volume
3 months and 6 months post intervention
response rate on FEV1 at 6 months post intervention
Time Frame: 6 months
proportion of patients with a minimal change of FEV1 > 100 ml
6 months
response rate on Transitional dyspnee index (TDI) at 3 months and 6 months post intervention
Time Frame: 3 months and 6 months post intervention
proportion of patients with a minimal change of -1 point on TDI
3 months and 6 months post intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in FEV1 (liters), FVC (liters), RV (liters), TLC (liters) at 3 and 6 months post intervention
Time Frame: 3 months and 6 months post intervention
Absolute difference from baseline values (liters)
3 months and 6 months post intervention
Change in RV/TLC ratio (%) at 3 and 6 months post intervention
Time Frame: 3 months and 6 months post intervention
Absolute difference from baseline values (%)
3 months and 6 months post intervention
Change in 6MWD (meters) at 3 and 6 months post intervention
Time Frame: 3 months and 6 months post intervention
Absolute difference from baseline values (meters)
3 months and 6 months post intervention
Change in physical activity at 3 months post intervention
Time Frame: 3 months post intervention
Absolute difference in stepcounts per day (n) from baseline values
3 months post intervention
Change in ProActive clinical visit questionnaire
Time Frame: 3 months post intervention
Absolute difference in points from baseline values
3 months post intervention
Change in BODE index
Time Frame: 3 months and 6 months post intervention
Absolute difference in points from baseline values
3 months and 6 months post intervention
changes in physical activity between 3 and 6 months of follow up (telecoaching period)
Time Frame: 3 months - 6 months post allocation
Absolute difference in stepcounts per day (n) 3 months - 6 months post allocation
3 months - 6 months post allocation
changes in ProActive clinical visit questionnaire between 3 and 6 months of follow up (telecoaching period)
Time Frame: 3 months - 6 months post allocation
Absolute difference in points 3 months - 6 months post allocation
3 months - 6 months post allocation
Comparing change in FEV1 (liters), FVC (liters), RV (liters), TLC (liters) at 3 and 6 months post EBV and LVRS
Time Frame: 3 months and 6 months post intervention (endoscopic or surgical)
Absolute difference from baseline values (liters) for both interventions
3 months and 6 months post intervention (endoscopic or surgical)
Comparing change in 6MWD at 3 and 6 months post EBV and LVRS
Time Frame: 3 months and 6 months post intervention (endoscopic or surgical)
Absolute difference from baseline values (meters) for both interventions
3 months and 6 months post intervention (endoscopic or surgical)
Comparing change in physical activity at 3 and 6 months post EBV and LVRS
Time Frame: 3 months and 6 months post intervention (endoscopic or surgical)
Absolute difference from baseline values (amount of steps per day) for both interventions
3 months and 6 months post intervention (endoscopic or surgical)
Comparing change in SGRQ at 3 and 6 months post EBV and LVRS
Time Frame: 3 months and 6 months post intervention (endoscopic or surgical)
Absolute difference from baseline values for both interventions
3 months and 6 months post intervention (endoscopic or surgical)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Wim Janssens, MD, University Hospital Leuven, Belgium
  • Principal Investigator: Dooms Christophe, MD, University Hospial Leuven, Belgium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

August 1, 2017

First Submitted That Met QC Criteria

August 28, 2017

First Posted (Actual)

August 29, 2017

Study Record Updates

Last Update Posted (Actual)

October 25, 2019

Last Update Submitted That Met QC Criteria

October 23, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Obstructive Pulmonary Disease

Clinical Trials on physical activity tele coaching

3
Subscribe