Endoscopic Long Volume Reduction by Endobronchial Valves in Belgium

Chronic Obstructive Pulmonary Disease Clinical Trial

— BEVA  

Official title:

Endoscopic Long Volume Reduction by Endobronchial Valves in Belgium

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03264768
• Other study ID #: s60207
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: December 2020

Study information

• Verified date: October 2019
• Source: KU Leuven
• Contact: Karen Denaux, sc, nurse
• Phone: 016 34 19 66
• Email: karen.denaux[@]uzleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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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Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

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.

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Flanders

Sponsors (1)

Lead Sponsor	Collaborator
KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in FEV1 (liters), FVC (liters), RV (liters), TLC (liters) at 3 and 6 months post intervention	Absolute difference from baseline values (liters)	3 months and 6 months post intervention
Other	Change in RV/TLC ratio (%) at 3 and 6 months post intervention	Absolute difference from baseline values (%)	3 months and 6 months post intervention
Other	Change in 6MWD (meters) at 3 and 6 months post intervention	Absolute difference from baseline values (meters)	3 months and 6 months post intervention
Other	Change in physical activity at 3 months post intervention	Absolute difference in stepcounts per day (n) from baseline values	3 months post intervention
Other	Change in ProActive clinical visit questionnaire	Absolute difference in points from baseline values	3 months post intervention
Other	Change in BODE index	Absolute difference in points from baseline values	3 months and 6 months post intervention
Other	changes in physical activity between 3 and 6 months of follow up (telecoaching period)	Absolute difference in stepcounts per day (n) 3 months - 6 months post allocation	3 months - 6 months post allocation
Other	changes in ProActive clinical visit questionnaire between 3 and 6 months of follow up (telecoaching period)	Absolute difference in points 3 months - 6 months post allocation	3 months - 6 months post allocation
Other	Comparing change in FEV1 (liters), FVC (liters), RV (liters), TLC (liters) at 3 and 6 months post EBV and LVRS	Absolute difference from baseline values (liters) for both interventions	3 months and 6 months post intervention (endoscopic or surgical)
Other	Comparing change in 6MWD at 3 and 6 months post EBV and LVRS	Absolute difference from baseline values (meters) for both interventions	3 months and 6 months post intervention (endoscopic or surgical)
Other	Comparing change in physical activity at 3 and 6 months post EBV and LVRS	Absolute difference from baseline values (amount of steps per day) for both interventions	3 months and 6 months post intervention (endoscopic or surgical)
Other	Comparing change in SGRQ at 3 and 6 months post EBV and LVRS	Absolute difference from baseline values for both interventions	3 months and 6 months post intervention (endoscopic or surgical)
Primary	response rate of FEV1 at 3 months post intervention	proportion of patients with a minimal change of FEV1 > 100 ml	3 months
Secondary	response rate on SGRQ at 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
Secondary	response rate on 6 minutes walking distance (6MWD) at 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
Secondary	response rate on residual volume (RV) at 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
Secondary	response rate on FEV1 at 6 months post intervention	proportion of patients with a minimal change of FEV1 > 100 ml	6 months
Secondary	response rate on Transitional dyspnee index (TDI) at 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