Bronchoscopic EmphysemA Treatment in THE NetherLands (BREATHE-NL)

Bronchoscopic Lung Volume Reduction Treatment in Clinical Practice: Introduction and Implementation in The Netherlands and Evaluation of a National Database

Rationale: New bronchoscopic treatments for emphysema have shown promise in clinical trials, improving lung function, exercise capacity and possibly survival and are now being adopted by a number of centres in the Netherlands. It is important to ensure that the benefits seen in clinical trials are in fact reflected in clinical practice and that the best use of this early 'real world' experience is made to optimise the development and use of these novel therapies.

Overall objective: to develop a national database to record bronchoscopic lung volume reduction procedures for patients with emphysema. This is desirable for audit purposes but will also be an important resource for research both in gathering data and in facilitating collaborations.

Study Overview

• Status: Recruiting
• Conditions: COPD

Detailed Description

Rationale: New bronchoscopic treatments for emphysema have shown promise in clinical trials, improving lung function, exercise capacity and possibly survival and are now being adopted by a number of centres in the Netherlands. It is important to ensure that the benefits seen in clinical trials are in fact reflected in clinical practice and that the best use of this early 'real world' experience is made to optimise the development and use of these novel therapies.

Overall objective: to develop a national database to record bronchoscopic lung volume reduction procedures for patients with emphysema. This is desirable for audit purposes but will also be an important resource for research both in gathering data and in facilitating collaborations.

Study design: This study is a nationwide, multicenter, observational post-marketing study with long-term follow up (5 years).

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

Main study parameters/endpoints:

The main study parameter is the assessment of Target Lung Volume Reduction (TLVR) and correct placement of the valves at CT-scan at 30 days post treatment. This is the most accurate and directly treatment related endpoint which will also be used for quality control.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Karin Klooster, PhD; Phone Number: +31503616161; Email: k.klooster@umcg.nl

Study Locations

• Netherlands
  • Groningen, Netherlands
    • Recruiting
    • University Medical Center Groningen
    • Principal Investigator: Dirk-Jan Slebos, MD PhD
    • Contact: Karin Klooster, PhD; Email: k.klooster@umcg.nl
  • Maastricht, Netherlands
    • Recruiting
    • Maastricht University Medical Center
    • Contact: Lowie Vanfleteren, MD Phd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study population exists of patients with severe emphysema who undergo a bronchoscopic lung volume reduction treatment with one-way endobronchial valves.

Description

Inclusion Criteria:

• Patient is scheduled for a bronchoscopic lung volume treatment using one-way valves.

Exclusion Criteria:

• There are no exclusion criteria for this study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of treatment	Quality will be assessed by a High resolution CT check at 30 day post-treatment of the placement of the valves.	Baseline-30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in lungfunction at 5 years follow up after treatment.	-Change from baseline in lungfunction measured by the bodybox at 5 years follow up.	Baseline- 5 years
Change from baseline in exercise capacity at 5 years follow up after treatment.	-Change from baseline in exercise capacity measured by the 6-minute walk distance test at 5 years follow up.	Baseline- 5 years
The incidence of a pneumothorax after the treatment until 5 years follow up.	The number of pneumothoraxes will be recorded between treatment and 5 years follow up.	Baseline- 5 year
Change from baseline in breathlessness at 5 years follow up after treatment.	-Change from baseline in breathlessness measured by the mMRC-scale (modified medical research council) at 5 years follow up.	Baseline- 5 years
Change from baseline in health status at 5 years follow up after treatment.	-Change from baseline in health status measured by the CAT (COPD Assessment test) score at 5 years follow up.	Baseline- 5 years

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Investigators: Principal Investigator: Dirk-Jan Slebos, MD PhD, UMCG

Publications and helpful links

General Publications

• Hartman JE, Klooster K, Ten Hacken NHT, van Dijk M, Slebos DJ. Patient Satisfaction and Attainment of Patient-Specific Goals after Endobronchial Valve Treatment. Ann Am Thorac Soc. 2021 Jan;18(1):68-74. doi: 10.1513/AnnalsATS.202004-342OC.

Helpful Links

• Website of the bronchoscopic intervention center of the UMCG

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Anticipated): January 1, 2028
• Study Completion (Anticipated): January 1, 2028

Study Registration Dates

• First Submitted: June 17, 2016
• First Submitted That Met QC Criteria: June 23, 2016
• First Posted (Estimate): June 28, 2016

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Bronchoscopy; Emphysema
• Additional Relevant MeSH Terms: Pathologic Processes; Emphysema
• Other Study ID Numbers: BREATHE-NL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO