Bronchoscopic EmphysemA Treatment in THE NetherLands

COPD Clinical Trial

— BREATHE-NL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02815683
• Other study ID #: BREATHE-NL
• Status: Recruiting
• Start date: September 2016
• Est. completion date: January 2028

Study information

• Verified date: June 2024
• Source: University Medical Center Groningen
• Contact: Karin Klooster, PhD
• Phone: +31503616161
• Email: k.klooster[@]umcg.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 2028
• Est. primary completion date: January 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• COPD
• Emphysema

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Maastricht University Medical Center	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Website of the bronchoscopic intervention center of the UMCG