A Trial on the Effects of Bronchoscopic Lung Volume Reduction in Severe Emphysema.

Not Applicable

Completed

• Conditions: Emphysema
• Interventions: Behavioral: Pulmonary rehabilitation; Device: EBV treatment

• Registration Number: NCT03474471
• Lead Sponsor: University Medical Center Groningen

Brief Summary

Rationale: The published clinical trials investigating the bronchoscopic lung volume reduction, showing important patient-related improvements in efficacy, led to the acknowledgement of the treatment in the GOLD-COPD2017 guidelines. Interaction with pulmonary rehabilitation, impact on patient-reported outcomes, physical activity, and extrapulmonary consequences are all topics to gain more insight in. This importantly, to further develop and optimize this innovative and personalized therapy.

Objective: To study in detail the impact and optimal timing of pulmonary rehabilitation (PR) on exercise physiology and patient-reported outcomes and the impact of the bronchoscopic lung volume reduction treatment using endobronchial valves (EBV) on cardiopulmonary function, metabolism and changes in body composition.

Study design: This study is a randomized controlled trial with 3 study-arms. Group 1 will first follow a PR program and afterwards undergo the EBV treatment. Group 2 will first undergo the EBV treatment and approximately 8 weeks later will follow a PR program. Group 3 will only undergo the EBV treatment (and can choose to follow a PR program after completing the 6 month FU visit).

Study population: The study population exist of patients with severe emphysema who undergo a bronchoscopic lung volume reduction treatment using one-way valves.

Intervention: Most patients will undergo a bronchoscopic lung volume reduction treatment using endobronchial valves and a pulmonary rehabilitation program. One group of patient will under a bronchoscopic lung volume reduction treatment using endobronchial valves and can choose whether they also want to follow a pulmonary rehabilitation program afterwards.

Main study parameters: The main study parameter is the difference in change in endurance time measured by an endurance cycle test between the EBV treatment group and the bronchoscopic lung volume reduction + rehabilitation group (EBV+PR).

Detailed Description

Rationale: The published clinical trials investigating the bronchoscopic lung volume reduction, showing important patient-related improvements in efficacy, led to the acknowledgement of the treatment in the GOLD-COPD2017 guidelines. Interaction with pulmonary rehabilitation, impact on patient-reported outcomes, physical activity, and extrapulmonary consequences are all topics to gain more insight in. This importantly, to further develop and optimize this innovative and personalized therapy.

Objective: To study in detail the impact and optimal timing of pulmonary rehabilitation (PR) on exercise physiology and patient-reported outcomes and the impact of the bronchoscopic lung volume reduction treatment using endobronchial valves (EBV) on cardiopulmonary function, metabolism and changes in body composition.

Study design: This study is a randomized controlled trial with 3 study-arms. Group 1 will first follow a PR program and afterwards undergo the EBV treatment. Group 2 will first undergo the EBV treatment and approximately 8 weeks later will follow a PR program. Group 3 will only undergo the EBV treatment (and can choose to follow a PR program after completing the 6 month FU visit).

Study population: The study population exist of patients with severe emphysema who undergo a bronchoscopic lung volume reduction treatment using one-way valves.

Intervention: Most patients will undergo a bronchoscopic lung volume reduction treatment using endobronchial valves and a pulmonary rehabilitation program. One group of patient will under a bronchoscopic lung volume reduction treatment using endobronchial valves and can choose whether they also want to follow a pulmonary rehabilitation program afterwards.

Main study parameters: The main study parameter is the difference in change in endurance time measured by an endurance cycle test between the EBV treatment group and the bronchoscopic lung volume reduction + rehabilitation group (EBV+PR).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This study has no major risks for the participating patients. The patients will be exposed to additional exercise capacity and physical activity measurements, 3 additional questionnaires, a CT scan of the quadriceps muscle, a DEXA scan and peripheral blood collection. Furthermore, a subgroup of patients will be exposed to a cardiac MRI or muscle and fat biopsies. Patient can directly benefit from the EBV treatment and the pulmonary rehabilitation program. Indirect benefit might be achieved, because, at a group level the investigators will learn more about this novel treatment for our severe emphysema patients and will be able to further optimize this treatment.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-03-09
• Study First Submitted QC: 2018-03-15
• Study First Posted: 2018-03-22
• Study Start: 2018-07-31
• Primary Completion: 2023-04-20
• Study Completion: 2023-04-20
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• COPD.
• FEV1 ≤45%pred AND FEV1/FVC <70%.
• TLC >100%pred AND RV>175%pred.
• CAT ≥18.
• >50% emphysema destruction @-910HU.
• >95% complete major fissure measured by quantitative CT analysis.
• Non-smoking >6 months.
• Signed informed consent.

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Exclusion Criteria

• PaCO2>8.0 kPa, or PaO2<6.0kPa.
• 6-minute walk test <160m.
• Significant chronic bronchitis, bronchiectasis, or other infectious lung disease.
• 3 of more hospitalizations due to pulmonary infection within last 12 months before baseline assessments
• Previous lobectomy, LVRS, or lung transplantation.
• LVEF<45% and or RVSP>50mmHg.
• Anticoagulant therapy which cannot be weaned off prior to procedure.
• Patient is significantly immunodeficient.
• Involved in other pulmonary drug studies within 30 days prior to this study.
• Pulmonary nodule which requires intervention
• Any disease or condition that interferes with completion of initial or follow-up assessments

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1:PR-EBV treatment	EBV treatment	Follow a Pulmonary rehabilitation program PRIOR to the EBV treatment
Group 2: EBV treatment-PR	Pulmonary rehabilitation	Follow a Pulmonary rehabilitation program AFTER the EBV treatment
Group 2: EBV treatment-PR	EBV treatment	Follow a Pulmonary rehabilitation program AFTER the EBV treatment
Group 1:PR-EBV treatment	Pulmonary rehabilitation	Follow a Pulmonary rehabilitation program PRIOR to the EBV treatment
Group 3: EBV treatment	EBV treatment	Only EBV treatment

Primary Outcome Measures

Name	Time	Method
Endurance time	After 6 months	The difference in change in endurance time measured by an endurance cycle test between the EBV treatment group and the bronchoscopic lung volume reduction + rehabilitation group (EBV+PR).

Secondary Outcome Measures

Name	Time	Method
Pulmonary rehabilitation1	After 6 months	• the difference between the EBV treatment group and the EBV+PR group in change in: * Physical activity measured by accelerometry
Pulmonary rehabilitation2	After 6 months	• the difference between the EBV treatment group and the EBV+PR group in change in: * Lung function measured by bodyplehtysmography
Pulmonary rehabilitation3	After 6 months	• the difference between the EBV treatment group and the EBV+PR group in change in: * Exercise capacity measured by an 6-minute walk distance test
Patient reported outcomes	After 6 months	• the change after EBV treatment in fatigue level measured by the CIS questionnaire.
Cardiopulmonary function	After 8 weeks	• the change after EBV treatment in RVEDVI as measured with cardiac MRI.
Metabolism and change in body composition	After 8 weeks	• the change after EBV treatment in fat-free mass index, fat mass, and fat distribution measured by a dexa scan.

Trial Locations

Locations (2)

CIRO; 🇳🇱 Horn, Netherlands

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands