- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03264768
Endoscopic Long Volume Reduction by Endobronchial Valves in Belgium (BEVA)
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Karen Denaux, sc, nurse
- Phone Number: 0032 016 34 19 66
- Email: karen.denaux@uzleuven.be
Study Contact Backup
- Name: Kristien De Bent, sc
- Phone Number: 0032 016 34 17 01
- Email: krisiten.debent@uzleuven.be
Study Locations
-
-
Flanders
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Leuven, Flanders, Belgium, 3000
- Recruiting
- UZ Leuven
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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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.
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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.
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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
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3 months and 6 months post intervention
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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
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proportion of patients with a minimal improvement of 30 meters on 6MWD
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3 months and 6 months post intervention
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response rate on residual volume (RV) at 3 months and 6 months post intervention
Time Frame: 3 months and 6 months post intervention
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proportion of patients with a minimal reduction of 400 ml on residual volume
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3 months and 6 months post intervention
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response rate on FEV1 at 6 months post intervention
Time Frame: 6 months
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proportion of patients with a minimal change of FEV1 > 100 ml
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6 months
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response rate on Transitional dyspnee index (TDI) at 3 months and 6 months post intervention
Time Frame: 3 months and 6 months post intervention
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proportion of patients with a minimal change of -1 point on TDI
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3 months and 6 months post intervention
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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
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Absolute difference from baseline values (liters)
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3 months and 6 months post intervention
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Change in RV/TLC ratio (%) at 3 and 6 months post intervention
Time Frame: 3 months and 6 months post intervention
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Absolute difference from baseline values (%)
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3 months and 6 months post intervention
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Change in 6MWD (meters) at 3 and 6 months post intervention
Time Frame: 3 months and 6 months post intervention
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Absolute difference from baseline values (meters)
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3 months and 6 months post intervention
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Change in physical activity at 3 months post intervention
Time Frame: 3 months post intervention
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Absolute difference in stepcounts per day (n) from baseline values
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3 months post intervention
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Change in ProActive clinical visit questionnaire
Time Frame: 3 months post intervention
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Absolute difference in points from baseline values
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3 months post intervention
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Change in BODE index
Time Frame: 3 months and 6 months post intervention
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Absolute difference in points from baseline values
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3 months and 6 months post intervention
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changes in physical activity between 3 and 6 months of follow up (telecoaching period)
Time Frame: 3 months - 6 months post allocation
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Absolute difference in stepcounts per day (n) 3 months - 6 months post allocation
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3 months - 6 months post allocation
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changes in ProActive clinical visit questionnaire between 3 and 6 months of follow up (telecoaching period)
Time Frame: 3 months - 6 months post allocation
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Absolute difference in points 3 months - 6 months post allocation
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3 months - 6 months post allocation
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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)
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Absolute difference from baseline values (liters) for both interventions
|
3 months and 6 months post intervention (endoscopic or surgical)
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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)
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Absolute difference from baseline values (meters) for both interventions
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3 months and 6 months post intervention (endoscopic or surgical)
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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)
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Absolute difference from baseline values (amount of steps per day) for both interventions
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3 months and 6 months post intervention (endoscopic or surgical)
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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)
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Absolute difference from baseline values for both interventions
|
3 months and 6 months post intervention (endoscopic or surgical)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wim Janssens, MD, University Hospital Leuven, Belgium
- Principal Investigator: Dooms Christophe, MD, University Hospial Leuven, Belgium
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- s60207
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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