Chronic Obstructive Pulmonary DiseaseBEVANCT03264768
Endoscopic Long Volume Reduction by Endobronchial Valves in Belgium
A study testing endobronchial valves, physical activity tele coaching and Lung volume reduction surgery (LVRS) in people with Chronic Obstructive Pulmonary Disease, run by KU Leuven at 1 site in Belgium.
Trial summary
This a single center non-randomised non-sham controlled intervention study evaluating the effectiveness and safety of endoscopic lung volume reduction by endobronchial valves Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- endobronchial valves, physical activity tele coaching and Lung volume reduction surgery (LVRS)
- Type of treatment
- Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Aug 2017to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40 - 75 years
- Confluent or destructive heterogeneous emphysema on CT
- Smoking cessation for at least 6m (proven by urinary cotinine levels)
- FEV1 < 60 %predicted, RV > 150 %predicted, TLC > 90 %predicted
- RV/TLC ratio ≥ 0.55
- 6MWD < 450 meter
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- mMRC ≥ 2
- Visual estimation of 70% complete fissure between target lobe and adjacent lobe on CT of referring physician
- LABA-LAMA bronchodilator therapy as a minimum therapy
- Able to sign informed consent
Who cannot join
- Homogenous emphysema
- PaCO2 > 60 mmHg with ambient air
- PaO2 < 45 mmHg with ambient air
- Previous LVRS, lung transplantation, lobectomy
- TLCO or FEV1 < 20% predicted
- Significant pulmonary hypertension (PaPsyst > 50 mm Hg)
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- Heart failure with reduced EF (< 40%)
- 6MWD < 100 meter
- BODE index ≥ 7 and eligible for transplantation
- Active cancer
- Life expectancy < 3 months
- Significant lung disease other than COPD/emphysema
- Unable to comply with study procedures
Trial locations and contacts
1 site in 1 country.
About this study
This a single center non-randomised non-sham controlled intervention study evaluating the effectiveness and safety of endoscopic lung volume reduction by endobronchial valves
Read the detailed description
The primary objective of the current study is to explore the effect of targeted lobar endobronchial lung volume reduction in symptomatic patients with severe emphysema and absent collateral ventilation, on lung function, exercise capacity and physical activity. As a secondary objective, changes in physical activity as result of a 3 month activity coaching program delivered between 3 to 6 months post intervention will be investigated. Exploratory objectives are to extend insight in the clinical characteristics of responders and non-responders and to address relationships between lung function response, physical functioning and its impact on inflammation, skeletal and cardiac function. Furthermore, comparison of the effects on lung function, exercise capacity, quality of life and physical activity between endoscopic lung volume reduction and surgical lung volume reduction will be made.
The study will also explore if treatment response can be optimised by an intermediate evaluation with CT scan one month after intervention. Endoscopic evaluation and repositioning of the endobronchial valves will be imposed in case no lober atelectasis is visualised.
.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- endobronchial valves, physical activity tele coaching, Lung volume reduction surgery (LVRS)
- Keywords
- valves, Chronic Obstructive Pulmonary Disease, endoscopic long volume reduction
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endobronchial valvesDevice
A ambulatory diagnostic bronchoscopy under general anesthesia will evaluate the presence or absence of collateral ventilation . The targeted lobar airway is temporarily occluded by means of a balloon catheter, which blocks inspiratory flow but allows expiratory flow, in order to assess whether the air flow gradually declines to zero, meaning absence of collateral ventilation. Only in case collateral ventilation is excluded, a therapeutic bronchoscopy will be scheduled to insert the one-directional endobronchial valves in the targeted lobar airways. We will only perform a unilateral intervention during which we will treat one or maximal two lobes at one side.
physical activity tele coachingBehavioural
3 month physical activity tele coaching intervention consisting of a project tailored smartphone application in combination with a step counter providing direct feedback.
Lung volume reduction surgery (LVRS)Procedure or surgery
Patients not eligible for endoscopic lung volume reduction (or non responders of this intervention) can be referred for surgical lung volume reduction. With this procedure, the most emphysematous parts of the lungs will be surgically removed.
| Study group | Role | What they receive |
|---|---|---|
| control | Other | standard care in case collateral ventilation is observed (by Chartis) with 3 months physical activity tele coaching between 3 and 6 months post allocation. Receives: Behavioral: physical activity tele coaching; Procedure: Lung volume reduction surgery (LVRS) |
| Endobronchial valves | Experimental | Endobronchial valves in case collateral ventilation is absent (by Chartis) with 3 months physical activity tele coaching between 3 and 6 months post intervention. Receives: Device: endobronchial valves; Behavioral: physical activity tele coaching; Procedure: Lung volume reduction surgery (LVRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate of FEV1 at 3 months post intervention
proportion of patients with a minimal change of FEV1 > 100 ml
Measured: 3 months
Secondary outcomes (5)
response rate on SGRQ at 3 months and 6 months post intervention
proportion of patients with a minimal change of -4 points on SGRQ
Measured: 3 months and 6 months post intervention
response rate on 6 minutes walking distance (6MWD) at 3 months and 6 months post intervention
proportion of patients with a minimal improvement of 30 meters on 6MWD
Measured: 3 months and 6 months post intervention
response rate on residual volume (RV) at 3 months and 6 months post intervention
proportion of patients with a minimal reduction of 400 ml on residual volume
Measured: 3 months and 6 months post intervention
response rate on FEV1 at 6 months post intervention
proportion of patients with a minimal change of FEV1 > 100 ml
Measured: 6 months
response rate on Transitional dyspnee index (TDI) at 3 months and 6 months post intervention
proportion of patients with a minimal change of -1 point on TDI
Measured: 3 months and 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start1 Aug 2017
- Primary completionSep 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wim Janssens, KU Leuven
- Investigators
- Wim Janssens, MD, Principal investigator, University hospital Leuven, BelgiumDooms Christophe, MD, Principal investigator, University Hospial Leuven, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264768
- Sponsor's protocol ID
- s60207
- Acronym
- BEVA
- Status last verified
- Oct 2019
- First submitted
- 1 Aug 2017
- Last updated
- 25 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Long Volume Reduction by Endobronchial Valves in Belgium
- ClinicalTrials.gov ID
- NCT03264768
- Acronym / sponsor ID
- BEVA / s60207
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- valves, Chronic Obstructive Pulmonary Disease, endoscopic long volume reduction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 29 Aug 2017 (actual)
- 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.
This a single center non-randomised non-sham controlled intervention study evaluating the effectiveness and safety of endoscopic lung volume reduction by endobronchial valves
Detailed description
The primary objective of the current study is to explore the effect of targeted lobar endobronchial lung volume reduction in symptomatic patients with severe emphysema and absent collateral ventilation, on lung function, exercise capacity and physical activity. As a secondary objective, changes in physical activity as result of a 3 month activity coaching program delivered between 3 to 6 months post intervention will be investigated. Exploratory objectives are to extend insight in the clinical characteristics of responders and non-responders and to address relationships between lung function response, physical functioning and its impact on inflammation, skeletal and cardiac function. Furthermore, comparison of the effects on lung function, exercise capacity, quality of life and physical activity between endoscopic lung volume reduction and surgical lung volume reduction will be made.
The study will also explore if treatment response can be optimised by an intermediate evaluation with CT scan one month after intervention. Endoscopic evaluation and repositioning of the endobronchial valves will be imposed in case no lober atelectasis is visualised.
.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Other | Behavioral: physical activity tele coaching, Procedure: Lung volume reduction surgery (LVRS)standard care in case collateral ventilation is observed (by Chartis) with 3 months physical activity tele coaching between 3 and 6 months post allocation. |
| Endobronchial valves | Experimental | Device: endobronchial valves, Behavioral: physical activity tele coaching, Procedure: Lung volume reduction surgery (LVRS)Endobronchial valves in case collateral ventilation is absent (by Chartis) with 3 months physical activity tele coaching between 3 and 6 months post intervention. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 40 - 75 years
- Confluent or destructive heterogeneous emphysema on CT
- Smoking cessation for at least 6m (proven by urinary cotinine levels)
- FEV1 < 60 %predicted, RV > 150 %predicted, TLC > 90 %predicted
- RV/TLC ratio ≥ 0.55
Key exclusion criteria (13 listed)
- Homogenous emphysema
- PaCO2 > 60 mmHg with ambient air
- PaO2 < 45 mmHg with ambient air
- Previous LVRS, lung transplantation, lobectomy
- TLCO or FEV1 < 20% predicted
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endobronchial valvesA ambulatory diagnostic bronchoscopy under general anesthesia will evaluate the presence or absence of collateral ventilation . The targeted lobar airway is temporarily occluded by means of a balloon catheter, which blocks inspiratory flow but allows expiratory flow, in order to assess whether the air flow gradually declines to zero, meaning absence of collateral ventilation. Only in case collateral ventilation is excluded, a therapeutic bronchoscopy will be scheduled to insert the one-directional endobronchial valves in the targeted lobar airways. We will only perform a unilateral intervention during which we will treat one or maximal two lobes at one side. | Device | Endobronchial valves |
| physical activity tele coaching3 month physical activity tele coaching intervention consisting of a project tailored smartphone application in combination with a step counter providing direct feedback. | Behavioural | Endobronchial valves, control |
| Lung volume reduction surgery (LVRS)Patients not eligible for endoscopic lung volume reduction (or non responders of this intervention) can be referred for surgical lung volume reduction. With this procedure, the most emphysematous parts of the lungs will be surgically removed. | Procedure or surgery | Endobronchial valves, control |
Primary outcome
response rate of FEV1 at 3 months post intervention
Time frame: 3 months
proportion of patients with a minimal change of FEV1 > 100 ml
5 secondary outcomes
response rate on SGRQ at 3 months and 6 months post intervention
Time frame: 3 months and 6 months post intervention
response rate on 6 minutes walking distance (6MWD) at 3 months and 6 months post intervention
Time frame: 3 months and 6 months post intervention
response rate on residual volume (RV) at 3 months and 6 months post intervention
Time frame: 3 months and 6 months post intervention
response rate on FEV1 at 6 months post intervention
Time frame: 6 months
response rate on Transitional dyspnee index (TDI) at 3 months and 6 months post intervention
Time frame: 3 months and 6 months post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
- 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. This study is not recruiting at the moment.
Wim Janssens, MD principal investigator
University hospital Leuven, Belgium
Dooms Christophe, MD principal investigator
University Hospial Leuven, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endobronchial valves, physical activity tele coaching and Lung volume reduction surgery (LVRS) in people with Chronic Obstructive Pulmonary Disease, run by KU Leuven at 1 site in Belgium.
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 10 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 25 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karen Denaux, sc, nurse (016 34 19 66 ext. 0032, karen.denaux@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate of FEV1 at 3 months post intervention (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Oct 2019.