BEVA: Endoscopic Long Volume Reduction by Endobronchial Valves in Belgium

• Sponsor: KU Leuven (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03264768
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 40
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

This a single center non-randomised non-sham controlled intervention study evaluating the effectiveness and safety of endoscopic lung volume reduction by endobronchial valves

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Device: endobronchial valves; Behavioral: physical activity tele coaching; Procedure: Lung volume reduction surgery (LVRS)	N/A

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.

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Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Endoscopic Long Volume Reduction by Endobronchial Valves in Belgium
• Actual Study Start Date: Aug 1, 2017
• Anticipated Primary Completion Date: Sep 1, 2020
• Anticipated Study Completion Date: Dec 1, 2020

Arms and Interventions

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.	Behavioral: physical activity tele coaching; 3 month physical activity tele coaching intervention consisting of a project tailored smartphone application in combination with a step counter providing direct feedback.; Procedure: Lung volume reduction surgery (LVRS); 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.	Device: endobronchial valves; 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.; Behavioral: physical activity tele coaching; 3 month physical activity tele coaching intervention consisting of a project tailored smartphone application in combination with a step counter providing direct feedback.; Procedure: Lung volume reduction surgery (LVRS); 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.

Outcome Measures

Primary Outcome Measures

1. response rate of FEV1 at 3 months post intervention [3 months]

   proportion of patients with a minimal change of FEV1 > 100 ml

Secondary Outcome Measures

1. response rate on SGRQ at 3 months and 6 months post intervention [3 months and 6 months post intervention]

   proportion of patients with a minimal change of -4 points on SGRQ

2. response rate on 6 minutes walking distance (6MWD) at 3 months and 6 months post intervention [3 months and 6 months post intervention]

   proportion of patients with a minimal improvement of 30 meters on 6MWD

3. response rate on residual volume (RV) at 3 months and 6 months post intervention [3 months and 6 months post intervention]

   proportion of patients with a minimal reduction of 400 ml on residual volume

4. response rate on FEV1 at 6 months post intervention [6 months]

   proportion of patients with a minimal change of FEV1 > 100 ml

5. response rate on Transitional dyspnee index (TDI) at 3 months and 6 months post intervention [3 months and 6 months post intervention]

   proportion of patients with a minimal change of -1 point on TDI

Other Outcome Measures

1. Change in FEV1 (liters), FVC (liters), RV (liters), TLC (liters) at 3 and 6 months post intervention [3 months and 6 months post intervention]

   Absolute difference from baseline values (liters)

2. Change in RV/TLC ratio (%) at 3 and 6 months post intervention [3 months and 6 months post intervention]

   Absolute difference from baseline values (%)

3. Change in 6MWD (meters) at 3 and 6 months post intervention [3 months and 6 months post intervention]

   Absolute difference from baseline values (meters)

4. Change in physical activity at 3 months post intervention [3 months post intervention]

   Absolute difference in stepcounts per day (n) from baseline values

5. Change in ProActive clinical visit questionnaire [3 months post intervention]

   Absolute difference in points from baseline values

6. Change in BODE index [3 months and 6 months post intervention]

   Absolute difference in points from baseline values

7. changes in physical activity between 3 and 6 months of follow up (telecoaching period) [3 months - 6 months post allocation]

   Absolute difference in stepcounts per day (n) 3 months - 6 months post allocation

8. changes in ProActive clinical visit questionnaire between 3 and 6 months of follow up (telecoaching period) [3 months - 6 months post allocation]

   Absolute difference in points 3 months - 6 months post allocation

9. Comparing change in FEV1 (liters), FVC (liters), RV (liters), TLC (liters) at 3 and 6 months post EBV and LVRS [3 months and 6 months post intervention (endoscopic or surgical)]

   Absolute difference from baseline values (liters) for both interventions

10. Comparing change in 6MWD at 3 and 6 months post EBV and LVRS [3 months and 6 months post intervention (endoscopic or surgical)]

    Absolute difference from baseline values (meters) for both interventions

11. Comparing change in physical activity at 3 and 6 months post EBV and LVRS [3 months and 6 months post intervention (endoscopic or surgical)]

    Absolute difference from baseline values (amount of steps per day) for both interventions

12. Comparing change in SGRQ at 3 and 6 months post EBV and LVRS [3 months and 6 months post intervention (endoscopic or surgical)]

    Absolute difference from baseline values for both interventions

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZ Leuven	Leuven	Flanders	Belgium	3000

Sponsors and Collaborators

• KU Leuven

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wim Janssens, Clinical Professor, KU Leuven
• ClinicalTrials.gov Identifier: NCT03264768
• Other Study ID Numbers: s60207
• First Posted: Aug 29, 2017
• Last Update Posted: Oct 25, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Wim Janssens, Clinical Professor, KU Leuven: valves; Chronic Obstructive Pulmonary Disease; endoscopic long volume reduction
• Additional relevant MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Oct 25, 2019