BREATHE-NL: Bronchoscopic EmphysemA Treatment in THE NetherLands

Sponsor

University Medical Center Groningen (Other)

Overall Status

Recruiting

CT.gov ID

NCT02815683

Collaborator

(none)

500

Enrollment

Locations

120

Anticipated Duration (Months)

250

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
COPD

Detailed Description

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 Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 1, 2016

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Sep 1, 2026

Outcome Measures

Primary Outcome Measures

Quality of treatment [Baseline-30 days]
Quality will be assessed by a High resolution CT check at 30 day post-treatment of the placement of the valves.

Secondary Outcome Measures

Change from baseline in lungfunction at 5 years follow up after treatment. [Baseline- 5 years]
-Change from baseline in lungfunction measured by the bodybox at 5 years follow up.
Change from baseline in exercise capacity at 5 years follow up after treatment. [Baseline- 5 years]
-Change from baseline in exercise capacity measured by the 6-minute walk distance test at 5 years follow up.
Change from baseline in breathlessness at 5 years follow up after treatment. [Baseline- 5 years]
-Change from baseline in breathlessness measured by the mMRC-scale at 5 years follow up.
Change from baseline in health status at 5 years follow up after treatment. [Baseline- 5 years]
-Change from baseline in health status measured by the CAT score at 5 years follow up.
The incidence of a pneumothorax after the treatment until 5 years follow up. [Baseline- 5 year]
The number of pneumothoraxes will be recorded between treatment and 5 years follow up.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center Groningen	Groningen		Netherlands
2	Maastricht University Medical Center	Maastricht		Netherlands

Sponsors and Collaborators

University Medical Center Groningen

Investigators

Principal Investigator: Dirk-Jan Slebos, MD PhD, UMCG

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Website of the bronchoscopic intervention center of the UMCG

Publications

None provided.

Responsible Party:

Dirk-Jan Slebos, MD PhD, University Medical Center Groningen

ClinicalTrials.gov Identifier:

NCT02815683

Other Study ID Numbers:

BREATHE-NL

First Posted:

Jun 28, 2016

Last Update Posted:

Dec 3, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Dirk-Jan Slebos, MD PhD, University Medical Center Groningen

Bronchoscopy

Emphysema

Additional relevant MeSH terms:

Emphysema

Study Results

No Results Posted as of Dec 3, 2021