COPDBREATHE-NLNCT02815683
Bronchoscopic EmphysemA Treatment in THE NetherLands
An observational study of COPD, run by University Medical Center Groningen at 2 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COPD
- How many people
- 500 participants
- Where
- 2 sitesNetherlands
- Study dates
- Sep 2016to Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population exists of patients with severe emphysema who undergo a bronchoscopic lung volume reduction treatment with one-way endobronchial valves.
Who may be able to join
- Patient is scheduled for a bronchoscopic lung volume treatment using one-way valves.
Who cannot join
- There are no exclusion criteria for this study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Recruiting
University Medical Center Groningen
Groningen
Karin Klooster, PhD, k.klooster@umcg.nl
Dirk-Jan Slebos, MD PhD
- Recruiting
Maastricht University Medical Center
Maastricht
Lowie Vanfleteren, MD Phd
About this study
Official title: 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.
Read the 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.
- Conditions
- COPD
- Keywords
- Bronchoscopy, Emphysema
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of treatment
Quality will be assessed by a High resolution CT check at 30 day post-treatment of the placement of the valves.
Measured: Baseline-30 days
Secondary outcomes (5)
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.
Measured: 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.
Measured: Baseline- 5 years
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.
Measured: 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.
Measured: 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.
Measured: Baseline- 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startSep 2016
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dirk-Jan Slebos, University Medical Center Groningen
- Investigators
- Dirk-Jan Slebos, MD PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815683
- Sponsor's protocol ID
- BREATHE-NL
- Acronym
- BREATHE-NL
- Status last verified
- Jun 2024
- First submitted
- 17 Jun 2016
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bakker JT, Hartman JE, Klooster K, Charbonnier JP, Tsiaousis M, Vliegenthart R, Slebos DJ. Endobronchial valve treatment improves chest-CT diaphragm configuration in COPD. Respir Med. 2024 Nov-Dec;234:107856. doi: 10.1016/j.rmed.2024.107856. Epub 2024 Nov 6.
PubMed 39515624Hartman 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.
PubMed 32881586
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchoscopic Lung Volume Reduction Treatment in Clinical Practice: Introduction and Implementation in The Netherlands and Evaluation of a National Database
- ClinicalTrials.gov ID
- NCT02815683
- Acronym / sponsor ID
- BREATHE-NL / BREATHE-NL
- Conditions
- COPD
- Keywords
- Bronchoscopy, Emphysema
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population exists of patients with severe emphysema who undergo a bronchoscopic lung volume reduction treatment with one-way endobronchial valves.
Key inclusion criteria (1 listed)
- Patient is scheduled for a bronchoscopic lung volume treatment using one-way valves.
Key exclusion criteria (1 listed)
- There are no exclusion criteria for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Change from baseline in lungfunction at 5 years follow up after treatment.
Time frame: Baseline- 5 years
Change from baseline in exercise capacity at 5 years follow up after treatment.
Time frame: Baseline- 5 years
Change from baseline in breathlessness at 5 years follow up after treatment.
Time frame: Baseline- 5 years
Change from baseline in health status at 5 years follow up after treatment.
Time frame: Baseline- 5 years
The incidence of a pneumothorax after the treatment until 5 years follow up.
Time frame: Baseline- 5 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Derived from this study: PubMed 39515624Bakker JT, Hartman JE, Klooster K, Charbonnier JP, Tsiaousis M, Vliegenthart R, Slebos DJ. Endobronchial valve treatment improves chest-CT diaphragm configuration in COPD. Respir Med. 2024 Nov-Dec;234:107856. doi: 10.1016/j.rmed.2024.107856. Epub 2024 Nov 6.
- Derived from this study: PubMed 32881586Hartman 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.
- Website of the bronchoscopic intervention center of the UMCGLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dirk-Jan Slebos, MD PhD principal investigator
University Medical Center Groningen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by University Medical Center Groningen at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karin Klooster, PhD (+31503616161, k.klooster@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of treatment (time frame: Baseline-30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02815683, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.