Clinical trial NCT03264768: Endoscopic Long Volume Reduction by Endobronchial Valves in Belgium
Official title: Endoscopic Long Volume Reduction by Endobronchial Valves in Belgium
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: valves
Chronic Obstructive Pulmonary Disease
endoscopic long volume reduction
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2017-08-29
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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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Eligibility criteria: 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

Primary outcomes:
measure: response rate of FEV1 at 3 months post intervention
timeFrame: 3 months
Secondary outcomes:
measure: response rate on SGRQ at 3 months and 6 months post intervention
timeFrame: 3 months and 6 months post intervention
measure: response rate on 6 minutes walking distance (6MWD) at 3 months and 6 months post intervention
timeFrame: 3 months and 6 months post intervention
measure: response rate on residual volume (RV) at 3 months and 6 months post intervention
timeFrame: 3 months and 6 months post intervention
measure: response rate on FEV1 at 6 months post intervention
timeFrame: 6 months
measure: response rate on Transitional dyspnee index (TDI) at 3 months and 6 months post intervention
timeFrame: 3 months and 6 months post intervention
Other outcomes:
measure: Change in FEV1 (liters), FVC (liters), RV (liters), TLC (liters) at 3 and 6 months post intervention
timeFrame: 3 months and 6 months post intervention
measure: Change in RV/TLC ratio (%) at 3 and 6 months post intervention
timeFrame: 3 months and 6 months post intervention
measure: Change in 6MWD (meters) at 3 and 6 months post intervention
timeFrame: 3 months and 6 months post intervention
measure: Change in physical activity at 3 months post intervention
timeFrame: 3 months post intervention
measure: Change in ProActive clinical visit questionnaire
timeFrame: 3 months post intervention
measure: Change in BODE index
timeFrame: 3 months and 6 months post intervention
measure: changes in physical activity between 3 and 6 months of follow up (telecoaching period)
timeFrame: 3 months - 6 months post allocation
measure: changes in ProActive clinical visit questionnaire between 3 and 6 months of follow up (telecoaching period)
timeFrame: 3 months - 6 months post allocation
measure: Comparing change in FEV1 (liters), FVC (liters), RV (liters), TLC (liters) at 3 and 6 months post EBV and LVRS
timeFrame: 3 months and 6 months post intervention (endoscopic or surgical)
measure: Comparing change in 6MWD at 3 and 6 months post EBV and LVRS
timeFrame: 3 months and 6 months post intervention (endoscopic or surgical)
measure: Comparing change in physical activity at 3 and 6 months post EBV and LVRS
timeFrame: 3 months and 6 months post intervention (endoscopic or surgical)
measure: Comparing change in SGRQ at 3 and 6 months post EBV and LVRS
timeFrame: 3 months and 6 months post intervention (endoscopic or surgical)
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Flanders
Study officials:
affiliation: University hospital Leuven, Belgium
name: Wim Janssens, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospial Leuven, Belgium
name: Dooms Christophe, MD
role: PRINCIPAL_INVESTIGATOR
References: