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Bronchoscopic EmphysemA Treatment in THE NetherLands (BREATHE-NL)

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ClinicalTrials.gov Identifier: NCT02815683
Recruitment Status : Recruiting
First Posted : June 28, 2016
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Dirk-Jan Slebos, University Medical Center Groningen

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
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.


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Study Type : Observational
Estimated 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 : September 2016
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema




Primary Outcome Measures :
  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 Outcome Measures :
  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 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 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02815683


Contacts
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Contact: Karin Klooster, PhD +31503616161 k.klooster@umcg.nl

Locations
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Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands
Contact: Karin Klooster, PhD       k.klooster@umcg.nl   
Principal Investigator: Dirk-Jan Slebos, MD PhD         
Maastricht University Medical Center Recruiting
Maastricht, Netherlands
Contact: Lowie Vanfleteren, MD Phd         
Sponsors and Collaborators
University Medical Center Groningen
Investigators
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Principal Investigator: Dirk-Jan Slebos, MD PhD UMCG

Additional Information:
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Responsible Party: Dirk-Jan Slebos, MD PhD, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02815683     History of Changes
Other Study ID Numbers: BREATHE-NL
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dirk-Jan Slebos, University Medical Center Groningen:
Bronchoscopy
Emphysema

Additional relevant MeSH terms:
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Emphysema
Pathologic Processes