Emphysema or COPDNCT04781582
LVRS Versus BLVR in Patients With Homogenous Emphysema, CLUB-HE Trial
A study testing Lung volume reduction surgery and Bronchoscopic lung volume reduction in people with Emphysema or COPD, run by Universität Duisburg-Essen at 1 site in Germany.
Trial summary
This is a prospective randomized clinical trial comparing surgical and bronchoscopic lung volume reduction in patients with advanced homogeneous emphysema suitable for both procedures. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Emphysema or COPD
- What is being tested?
- Lung volume reduction surgery and Bronchoscopic lung volume reduction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteGermany
- Study dates
- 8 Jun 2021to Nov 2024
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD III-IV
- Age ≥ 18 years
- FEV1 < 50% predicted after bronchodilatation
- Significant hyperinflation (TLC >100% predicted, RV > 200% predicted, RV/TLC > 60%)
- Non-smoker or ex-smoker for > 3 months (documented by cotinine testing)
- 6 MWT >150 m and ≤ 450m
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- MRC dyspnea score > 3
- Homogenous emphysema as assessed by HR-CT (< 15% difference in emphysema destruction score between target lobe and ipsilateral lobe) [16, 17]
- Uni- or bilateral collateral ventilation (CV) negative result assessed fissure completeness>95% in QCT and confirmed by a bronchoscopic procedure (Chartis©)
- Optimal medical therapy for > 3months, sufficient rehabilitation status with no need for further training/rehabilitation or rehabilitation within 6 months prior to intervention.
- Body Mass Index (BMI) > 18, but < 35 kg/m2
- Daily dose of prednisone ≤ 10mg
Who cannot join
- Contraindication against either LVRS or BLVR and/or to surgery and bronchoscopy in general
- Major comorbidities limiting survival
- Age ≥ 80 years
- Nicotine abuse within 3 months (documented by cotinine testing)
- Predominance of either left or right lung of >70% in perfusion SPECT scintigraphy
- FEV1 and/or DLCO <20% predicted (post bronchodilatation)
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- Untreated Hypoxemia (PaO2 < 50 mmHg)
- Untreated Hypercapnia (PaCO2 > 50 mmHg)
- Significant pulmonary fibrosis or bronchiectasis
- Destroyed/vanished lung on HR-CT
- Previous chest surgery or bronchoscopic interventions
- Pulmonary hypertension (sPAP > 35 mmHg)
- Active waiting list for lung transplantation
- Patient is not able to understand and willing to sign a written informed consent document.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Medicine Essen
Essen, North Rhine-Westphalia, 45239
Clemens Aigner, Prof. MD, +49201433 ext. 4011, clemens.aigner@rlk.uk-essen.de
Kaid Darwiche, Prof. MD, +49201433 ext. 4222, kaid.darwiche@rlk.uk-essen.de
About this study
Official title: Comparison of Lung Volume Reduction Surgery Versus Bronchoscopic Lung Volume Reduction in Patients With Homogenous Emphysema: A Prospective Randomized Trial
This is a prospective randomized clinical trial comparing surgical and bronchoscopic lung volume reduction in patients with advanced homogeneous emphysema suitable for both procedures.
Read the detailed description
Lung volume reduction surgery (LVRS) as well as bronchoscopic lung volume reduction (BLVR) provide functional improvements in selected patients with homogenous emphysema and pronounced hyperinflation. A direct comparison of LVRS and BLVR in patients with homogenous emphysema is not available, thus the study will provide important data to guide treatment selection in this patient population.
- Conditions
- Emphysema or COPD
- Being tested
- Lung volume reduction surgery, Bronchoscopic lung volume reduction
- Medical subject headings
- Emphysema, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung volume reduction surgeryProcedure or surgery
Surgical lung volume reduction
Bronchoscopic lung volume reductionProcedure or surgery
Bronchoscopic lung volume reduction by endobronchial valves
| Study group | Role | What they receive |
|---|---|---|
| Lung volume reduction surgery arm | Active comparator | Bilateral videothoracoscopic lung volume reduction surgery by wedge resection. Unilateral procedures are possible in case of severe adhesions or intraoperative instability. In these cases a staged approach with contralateral LVRS within 3 months is possible. Receives: Procedure: Lung volume reduction surgery |
| Bronchoscopic lung volume reduction arm | Active comparator | Primarily unilateral bronchoscopic lung volume reduction by endobronchial valves. If a bilateral procedure is feasible it must be performed within 3 months after the first intervention. Receives: Procedure: Bronchoscopic lung volume reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FEV1 compared to baseline (deltaFEV1)
Percent change in FEV1
Measured: 6 months post intervention
Secondary outcomes (11)
Change in BODE Index (Body mass index, airflow obstruction, dyspnoea and exercise capacity in chronic obstructive pulmonary disease)
Combined score including BMI, FEV1, 6 MWT, MRC dyspnoea score; range 0 (best) - 10 (worst)
Measured: 3, 6 months post intervention
Change in TLC
Percent change in Total Lung Capacity
Measured: 3, 6 months post intervention
Change in RV
Percent change in Residual Volume
Measured: 3, 6 months post intervention
Change in RV/TLC
Percent change in RV/TLC ratio
Measured: 3, 6 months post intervention
Change in DLCO
Percent change in diffusion capacity
Measured: 3, 6 months post intervention
Change in systolic pulmonary artery pressure
measured by echocardiography
Measured: 6 months post intervention
Changes in health-related quality of life measured by SGRQ
St. George´s Respiratory Questionnaire (score 0-100, higher scores indicating more limitations)
Measured: 3, 6 months post intervention
Changes in respiratory health status measured by CAT
COPD Assessment Test (CAT)
Measured: 3, 6 months post intervention
Mortality
Number of deaths 30 days post intervention
Measured: 30 days post intervention
Overall survival
Percent of patients alive 6 months post intervention
Measured: 6 months post intervention
Incidence of (serious) adverse events
Number of events periprocedural, 1, 3 and 6 months post intervention
Measured: Periprocedural, 1, 3, 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 posted4 Mar 2021
- Study start8 Jun 2021
- Primary completionMay 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emphysema or COPDStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- single center, 1:1 randomized, open label, controlled
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clemens Aigner, Universität Duisburg-Essen
- Investigators
- Clemens Aigner, Prof. MD, Principal investigator, Universität Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04781582
- Sponsor's protocol ID
- 20-9518-BO
- Status last verified
- Sep 2021
- First submitted
- 25 Feb 2021
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Lung Volume Reduction Surgery Versus Bronchoscopic Lung Volume Reduction in Patients With Homogenous Emphysema: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT04781582
- Acronym / sponsor ID
- 20-9518-BO
- Conditions
- Emphysema or COPD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 4 Mar 2021 (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 is a prospective randomized clinical trial comparing surgical and bronchoscopic lung volume reduction in patients with advanced homogeneous emphysema suitable for both procedures.
Detailed description
Lung volume reduction surgery (LVRS) as well as bronchoscopic lung volume reduction (BLVR) provide functional improvements in selected patients with homogenous emphysema and pronounced hyperinflation. A direct comparison of LVRS and BLVR in patients with homogenous emphysema is not available, thus the study will provide important data to guide treatment selection in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- single center, 1:1 randomized, open label, controlled
| Arm | Type | Receives |
|---|---|---|
| Lung volume reduction surgery arm | Active comparator | Procedure: Lung volume reduction surgeryBilateral videothoracoscopic lung volume reduction surgery by wedge resection. Unilateral procedures are possible in case of severe adhesions or intraoperative instability. In these cases a staged approach with contralateral LVRS within 3 months is possible. |
| Bronchoscopic lung volume reduction arm | Active comparator | Procedure: Bronchoscopic lung volume reductionPrimarily unilateral bronchoscopic lung volume reduction by endobronchial valves. If a bilateral procedure is feasible it must be performed within 3 months after the first intervention. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- COPD III-IV
- Age ≥ 18 years
- FEV1 < 50% predicted after bronchodilatation
- Significant hyperinflation (TLC >100% predicted, RV > 200% predicted, RV/TLC > 60%)
- Non-smoker or ex-smoker for > 3 months (documented by cotinine testing)
Key exclusion criteria (15 listed)
- Contraindication against either LVRS or BLVR and/or to surgery and bronchoscopy in general
- Major comorbidities limiting survival
- Age ≥ 80 years
- Nicotine abuse within 3 months (documented by cotinine testing)
- Predominance of either left or right lung of >70% in perfusion SPECT scintigraphy
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 |
|---|---|---|
| Lung volume reduction surgerySurgical lung volume reduction | Procedure or surgery | Lung volume reduction surgery arm |
| Bronchoscopic lung volume reductionBronchoscopic lung volume reduction by endobronchial valves | Procedure or surgery | Bronchoscopic lung volume reduction arm |
Primary outcome
Change in FEV1 compared to baseline (deltaFEV1)
Time frame: 6 months post intervention
Percent change in FEV1
11 secondary outcomes
Change in BODE Index (Body mass index, airflow obstruction, dyspnoea and exercise capacity in chronic obstructive pulmonary disease)
Time frame: 3, 6 months post intervention
Change in TLC
Time frame: 3, 6 months post intervention
Change in RV
Time frame: 3, 6 months post intervention
Change in RV/TLC
Time frame: 3, 6 months post intervention
Change in DLCO
Time frame: 3, 6 months post intervention
Change in systolic pulmonary artery pressure
Time frame: 6 months post intervention
Changes in health-related quality of life measured by SGRQ
Time frame: 3, 6 months post intervention
Changes in respiratory health status measured by CAT
Time frame: 3, 6 months post intervention
Mortality
Time frame: 30 days post intervention
Overall survival
Time frame: 6 months post intervention
Incidence of (serious) adverse events
Time frame: Periprocedural, 1, 3, 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 28 Sep 2021.
- 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.
Clemens Aigner, Prof. MD principal investigator
Universität Duisburg-Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung volume reduction surgery and Bronchoscopic lung volume reduction in people with Emphysema or COPD, run by Universität Duisburg-Essen at 1 site in Germany.
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 12 inclusion and 15 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 28 Sep 2021. 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 Germany. 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 Clemens Aigner, Prof. MD (+49201433 ext. 4011, clemens.aigner@rlk.uk-essen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in FEV1 compared to baseline (deltaFEV1) (time frame: 6 months post intervention). 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 28 Sep 2021.