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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03474471
Recruitment Status : Recruiting
First Posted : March 22, 2018
Last Update Posted : April 8, 2022
Sponsor:
Collaborators:
Maastricht University Medical Center
Center of Expertise for Chronic Organ Failure
Information provided by (Responsible Party):
Dirk-Jan Slebos, 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).


Condition or disease Intervention/treatment Phase
Emphysema Behavioral: Pulmonary rehabilitation Device: EBV treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Controlled Trial on the Systemic Effects of Bronchoscopic Lung Volume Reduction in Patients With Severe Emphysema.
Actual Study Start Date : July 31, 2018
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : March 1, 2023

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. Endurance time [ Time Frame: 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 :
  1. Pulmonary rehabilitation1 [ Time Frame: After 6 months ]

    • the difference between the EBV treatment group and the EBV+PR group in change in:

    • Physical activity measured by accelerometry

  2. Pulmonary rehabilitation2 [ Time Frame: After 6 months ]

    • the difference between the EBV treatment group and the EBV+PR group in change in:

    • Lung function measured by bodyplehtysmography

  3. Pulmonary rehabilitation3 [ Time Frame: 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

  4. Patient reported outcomes [ Time Frame: After 6 months ]
    • the change after EBV treatment in fatigue level measured by the CIS questionnaire.

  5. Cardiopulmonary function [ Time Frame: After 8 weeks ]
    • the change after EBV treatment in RVEDVI as measured with cardiac MRI.

  6. Metabolism and change in body composition [ Time Frame: After 8 weeks ]
    • the change after EBV treatment in fat-free mass index, fat mass, and fat distribution measured by a dexa scan.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03474471


Contacts
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Contact: Dirk-Jan Slebos, MD PhD +31503616161 d.j.slebos@umcg.nl

Locations
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Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands
Contact: Dirk-Jan Slebos, MD PhD    +31503616161    d.j.slebos@umcg.nl   
Principal Investigator: Dirk-Jan Slebos, MD PhD         
CIRO Recruiting
Horn, Netherlands
Contact: Lowie Vanfleteren, MD Phd         
Sponsors and Collaborators
University Medical Center Groningen
Maastricht University Medical Center
Center of Expertise for Chronic Organ Failure
Investigators
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Principal Investigator: Dirk-Jan Slebos, MD PhD UMCG
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dirk-Jan Slebos, dr. D.J. Slebos, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT03474471    
Other Study ID Numbers: SOLVE
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: April 8, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pulmonary Emphysema
Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases