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NCT Number: NCT02815683

Bronchoscopic EmphysemA Treatment in THE NetherLands

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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Emphysema Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Groningen, Groningen, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Quality of treatment

    Time frame: 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 outcomes

  1. Change from baseline in lungfunction at 5 years follow up after treatment.

    Time frame: Baseline- 5 years

    -Change from baseline in lungfunction measured by the bodybox at 5 years follow up.

  2. Change from baseline in exercise capacity at 5 years follow up after treatment.

    Time frame: Baseline- 5 years

    -Change from baseline in exercise capacity measured by the 6-minute walk distance test at 5 years follow up.

  3. Change from baseline in breathlessness at 5 years follow up after treatment.

    Time frame: Baseline- 5 years

    -Change from baseline in breathlessness measured by the mMRC-scale (modified medical research council) at 5 years follow up.

  4. Change from baseline in health status at 5 years follow up after treatment.

    Time frame: Baseline- 5 years

    -Change from baseline in health status measured by the CAT (COPD Assessment test) score at 5 years follow up.

  5. The incidence of a pneumothorax after the treatment until 5 years follow up.

    Time frame: Baseline- 5 year

    The number of pneumothoraxes will be recorded between treatment and 5 years follow up.

Study contacts

Contact information is provided by the study sponsor or research team.

Karin Klooster, PhD

CONTACT

[email protected]

+31503616161

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

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

Acronym: BREATHE-NL

Important dates

Study start
2016
Primary completion
2028
Study completion
2028
First posted
Jun 28, 2016
Registry last updated
Jun 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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