SOLVE: A Trial on the Effects of Bronchoscopic Lung Volume Reduction in Severe Emphysema.
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1:PR-EBV treatment Follow a Pulmonary rehabilitation program PRIOR to the EBV treatment |
Behavioral: Pulmonary rehabilitation
Following a PR program
Device: EBV treatment
Bronchoscopic lung volume reduction using endobronchial valves (EBV)
|
| Experimental: Group 2: EBV treatment-PR Follow a Pulmonary rehabilitation program AFTER the EBV treatment |
Behavioral: Pulmonary rehabilitation
Following a PR program
Device: EBV treatment
Bronchoscopic lung volume reduction using endobronchial valves (EBV)
|
| Active Comparator: Group 3: EBV treatment Only EBV treatment |
Device: EBV treatment
Bronchoscopic lung volume reduction using endobronchial valves (EBV)
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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COPD.
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FEV1 ≤45%pred AND FEV1/FVC <70%.
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TLC >100%pred AND RV>175%pred.
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CAT ≥18.
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50% emphysema destruction @-910HU.
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95% complete major fissure measured by quantitative CT analysis.
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Non-smoking >6 months.
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Signed informed consent.
Exclusion Criteria:
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PaCO2>8.0 kPa, or PaO2<6.0kPa.
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6-minute walk test <160m.
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Significant chronic bronchitis, bronchiectasis, or other infectious lung disease.
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3 of more hospitalizations due to pulmonary infection within last 12 months before baseline assessments
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Previous lobectomy, LVRS, or lung transplantation.
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LVEF<45% and or RVSP>50mmHg.
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Anticoagulant therapy which cannot be weaned off prior to procedure.
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Patient is significantly immunodeficient.
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Involved in other pulmonary drug studies within 30 days prior to this study.
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Pulmonary nodule which requires intervention
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Any disease or condition that interferes with completion of initial or follow-up assessments
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Medical Center Groningen | Groningen | Netherlands | ||
| 2 | CIRO | Horn | Netherlands |
Sponsors and Collaborators
- University Medical Center Groningen
- Maastricht University Medical Center
- Center of Expertise for Chronic Organ Failure
Investigators
- Principal Investigator: Dirk-Jan Slebos, MD PhD, UMCG
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SOLVE