NCT03474471

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 22, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

July 31, 2018

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2023

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

4.7 years

First QC Date

March 9, 2018

Last Update Submit

May 9, 2023

Conditions

Emphysema

Outcome Measures

Primary Outcomes (1)

  • Endurance time

    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).

    After 6 months

Secondary Outcomes (6)

  • Pulmonary rehabilitation1

    After 6 months

  • Pulmonary rehabilitation2

    After 6 months

  • Pulmonary rehabilitation3

    After 6 months

  • Patient reported outcomes

    After 6 months

  • Cardiopulmonary function

    After 8 weeks

  • +1 more secondary outcomes

Study Arms (3)

Group 1:PR-EBV treatment

EXPERIMENTAL

Follow a Pulmonary rehabilitation program PRIOR to the EBV treatment

Behavioral: Pulmonary rehabilitationDevice: EBV treatment

Group 2: EBV treatment-PR

EXPERIMENTAL

Follow a Pulmonary rehabilitation program AFTER the EBV treatment

Behavioral: Pulmonary rehabilitationDevice: EBV treatment

Group 3: EBV treatment

ACTIVE COMPARATOR

Only EBV treatment

Device: EBV treatment

Interventions

Pulmonary rehabilitationBEHAVIORAL

Following a PR program

Group 1:PR-EBV treatmentGroup 2: EBV treatment-PR
EBV treatmentDEVICE

Bronchoscopic lung volume reduction using endobronchial valves (EBV)

Group 1:PR-EBV treatmentGroup 2: EBV treatment-PRGroup 3: EBV treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • PaCO2\>8.0 kPa, or PaO2\<6.0kPa.
  • minute walk test \<160m.
  • Significant chronic bronchitis, bronchiectasis, or other infectious lung disease.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Medical Center Groningen

Groningen, Netherlands

Location

CIRO

Horn, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 40791921DERIVED

  • 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.

    PMID: 35584341DERIVED

MeSH Terms

Conditions

Emphysema

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dirk-Jan Slebos, MD PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr. D.J. Slebos

Study Record Dates

First Submitted

March 9, 2018

First Posted

March 22, 2018

Study Start

July 31, 2018

Primary Completion

April 20, 2023

Study Completion

April 20, 2023

Last Updated

May 10, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

NL(2)