Endoscopic Long Volume Reduction by Endobronchial Valves in Belgium

Not Applicable

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Behavioral: physical activity tele coaching; Device: endobronchial valves; Procedure: Lung volume reduction surgery (LVRS)

• Registration Number: NCT03264768
• Lead Sponsor: KU Leuven

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

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 Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2017-08-01
• Study First Submitted QC: 2017-08-28
• Study First Posted: 2017-08-29
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-23
• Last Update Posted: 2019-10-25
• Primary Completion: 2020-09
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	physical activity tele coaching	standard care in case collateral ventilation is observed (by Chartis) with 3 months physical activity tele coaching between 3 and 6 months post allocation.
Endobronchial valves	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.
control	Lung volume reduction surgery (LVRS)	standard care in case collateral ventilation is observed (by Chartis) with 3 months physical activity tele coaching between 3 and 6 months post allocation.
Endobronchial valves	physical activity tele coaching	Endobronchial valves in case collateral ventilation is absent (by Chartis) with 3 months physical activity tele coaching between 3 and 6 months post intervention.
Endobronchial valves	Lung volume reduction surgery (LVRS)	Endobronchial valves in case collateral ventilation is absent (by Chartis) with 3 months physical activity tele coaching between 3 and 6 months post intervention.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
response rate on FEV1 at 6 months post intervention	6 months	proportion of patients with a minimal change of FEV1 \> 100 ml
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
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
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
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

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Flanders, Belgium