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

NCT ID: NCT03474471

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-31
• Study Completion Date: 2023-04-20

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.

Conditions

Emphysema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1:PR-EBV treatment

Follow a Pulmonary rehabilitation program PRIOR to the EBV treatment

Group Type: EXPERIMENTAL

Pulmonary rehabilitation

Intervention Type: BEHAVIORAL

Following a PR program

EBV treatment

Intervention Type: DEVICE

Bronchoscopic lung volume reduction using endobronchial valves (EBV)

Group 2: EBV treatment-PR

Follow a Pulmonary rehabilitation program AFTER the EBV treatment

Group Type: EXPERIMENTAL

Pulmonary rehabilitation

Intervention Type: BEHAVIORAL

Following a PR program

EBV treatment

Intervention Type: DEVICE

Bronchoscopic lung volume reduction using endobronchial valves (EBV)

Group 3: EBV treatment

Only EBV treatment

Group Type: ACTIVE_COMPARATOR

EBV treatment

Intervention Type: DEVICE

Bronchoscopic lung volume reduction using endobronchial valves (EBV)

Interventions

Pulmonary rehabilitation

Following a PR program

Intervention Type: BEHAVIORAL

EBV treatment

Bronchoscopic lung volume reduction using endobronchial valves (EBV)

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: collaborator

Center of Expertise for Chronic Organ Failure

OTHER

Sponsor Role: collaborator

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Dirk-Jan Slebos

dr. D.J. Slebos

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dirk-Jan Slebos, MD PhD

Role: PRINCIPAL_INVESTIGATOR

UMCG

Locations

University Medical Center Groningen

Groningen, , Netherlands

CIRO

Horn, , Netherlands

Countries

Netherlands

References

Posthuma R, van der Molen MC, Vaes AW, Hartman JE, Spruit MA, Slebos DJ, Vanfleteren LEGW. The impact of bronchoscopic lung volume reduction with endobronchial valves with or without pulmonary rehabilitation on symptoms of fatigue, anxiety and depression: a multicentre randomised controlled trial. ERJ Open Res. 2025 Aug 11;11(4):00892-2024. doi: 10.1183/23120541.00892-2024. eCollection 2025 Jul.

Reference Type: DERIVED

PMID: 40791921 (View on PubMed)

van der Molen MC, Hartman JE, Vanfleteren LEGW, Kerstjens HAM, van Melle JP, Willems TP, Slebos DJ. Reduction of Lung Hyperinflation Improves Cardiac Preload, Contractility, and Output in Emphysema: A Clinical Trial in Patients Who Received Endobronchial Valves. Am J Respir Crit Care Med. 2022 Sep 15;206(6):704-711. doi: 10.1164/rccm.202201-0214OC.

Reference Type: DERIVED

PMID: 35584341 (View on PubMed)

Other Identifiers

SOLVE

Identifier Type: -

Identifier Source: org_study_id