EmphysemaPhase 4EUROPTNCT00730301
EUROPT Clinical Trial to Study the Efficacy of One-Way Valve Implantation (New Treatment Algorithm) in Patients With Heterogeneous Emphysema
A Phase 4 study testing Bronchoscopic Lung Volume Reduction (BLVR) in people with Emphysema and Chronic Obstructive Pulmonary Disease, run by LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology at 3 sites in 2 countries.
Trial summary
The purpose of this study is to assess the efficacy of a new treatment algorithm for bronchoscopic lung volume reduction (BLVR) in patients with emphysema based on the information of emphysema heterogeneity, destruction score, and fissure analysis. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Emphysema, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Bronchoscopic Lung Volume Reduction (BLVR)
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jul 2007to Sep 2008
- Phase
- Phase 4
- 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
- Patient diagnosed by HRCT Core Lab with eligible heterogeneous disease distribution and at least one complete oblique fissure.
- Age from 40 to 75 years
- BMI < 32 kg/m2
- FEV1 < 40% of predicted value, FEV1/FVC < 70%
- TLC > 120% predicted, RV > 150% predicted.
- Stable with < 20 mg prednisone (or equivalent) qd
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- PaCO2 < 50mm Hg
- PaO2 > 45 mm Hg on room air
- 6-min walk of > 50m (without rehabilitation) or > 100m (with rehabilitation)
- Nonsmoking for 4 months prior to initial interview and throughout screening
- The patient agrees to all protocol required follow-up intervals.
- The patient has no child bearing potential
- The patient is willing and able to complete protocol required baseline assessments and procedures
Who cannot join
- Prior endobronchial treatment for emphysema
- Pleural or interstitial disease that precludes surgery.
- Prior lung transplant, LVRS, median sternotomy, bullectomy or lobectomy.
- Clinically significant bronchiectasis
- Pulmonary nodule requiring surgery
- History of recurrent respiratory infections (> 3 hospitalization in the last year)
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- Clinically significant (> 4 Tablespoons per day) sputum production
- Fever, elevated white cell count, or other evidence of active infection
- Dysrhythmia that might pose a risk during exercise or training
- Congestive heart failure within 6 mo and LVEF < 45%
- Evidence or history of Cor Pulmonale
- Resting bradycardia (< 50 beats/min), frequent multifocal PVCs, complex ventricular arrhythmia, sustained SVT
- History of exercise-related syncope
- MI within 6 mo and LVEF < 45%
- Evidence of systemic disease or neoplasia expected to compromise survival during 5-yr period
- Any disease or condition that interferes with completion of initial or follow-up assessments
- Patient is currently enrolled in another clinical trial
- Patient is unable to complete 3 minutes of unloaded peddling on cycle ergometer
- Alpha-1-Antitrypsin Deficiency
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Belgium2 sites, 2 recruiting
- Recruiting
University Antwerp
Antwerp
Paul Germonpre, MD, Paul.Germonpre@uza.be
Paul Germonpre, MD
- Recruiting
University Brussels
Brussels
Marc Meysman, MD, Marc.Meysman@uzbrussel.be
Marc Meysman, MD
Austria1 site, 1 recruiting
- Recruiting
Otto Wagner Hospital
Vienna, State of Vienna, 1140
Arschang Valipour, MD, arschang.valipour@wienkav.at
About this study
Official title: A Multi-Center, Prospective, Clinical Trial Designed to Study the Efficacy of One-Way Valve Implantation Based on a New Treatment Algorithm in Patients With Heterogeneous Emphysema
The purpose of this study is to assess the efficacy of a new treatment algorithm for bronchoscopic lung volume reduction (BLVR) in patients with emphysema based on the information of emphysema heterogeneity, destruction score, and fissure analysis.
Read the detailed description
Emphysema is a progressive pulmonary disease characterized by abnormal and permanent enlargement of air spaces distal to terminal bronchioles accompanied by the destruction of pulmonary parenchyma. Treatment includes inhaled bronchodilator therapy, rehabilitation and/or oxygen treatment. In addition to the above, patients with severe emphysema may benefit from surgical lung volume reduction and/or lung transplantation. The rationale for lung volume reduction surgery is that reducing lung size would restore elastic recoil of the lung and improve chest wall and diaphragm mechanics. It has previously been shown that particularly patients with heterogeneous emphysema seem to benefit most from surgical lung volume reduction.
Bronchoscopic lung volume reduction (BLVR) has recently been introduced as a less invasive potential alternative to surgical lung volume reduction. BLVR attempts to achieve the effects of surgery, by placing bronchial prostheses using a fibreoptic bronchoscope to selectively occlude the airways supplying the most affected hyperinflated regions of the emphysematous lung, while permitting exhaled gas to escape. This attempts to achieve segmental or lobar volume reduction, simulating the effects of surgical LVR. Recent trials of BLVR using endobronchial one-way valves demonstrated significant improvements in lung function parameters, exercise capacity and quality of life in patients with end-stage emphysema. The treatment algorithm for valve implantations to achieve BLVR, however, varied considerably in these reports as well as clinical and functional response rates. Subset analysis of these studies revealed that particularly, but not exclusively, patients with radiological signs of lung volume reduction treated unilaterally showed significant clinical improvements, whereas most patients without signs of lung volume reduction did not experience these benefits. The present study investigates the response to BLVR based on a new treatment algorithm including lung function criteria and computed tomography of the thorax.
- Conditions
- Emphysema, Chronic Obstructive Pulmonary Disease
- Being tested
- Bronchoscopic Lung Volume Reduction (BLVR)
- Keywords
- Emphysema, Chronic obstructive pulmonary disease, Lung volume reduction, Lung function
- 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.
Bronchoscopic Lung Volume Reduction (BLVR)Procedure or surgery
Also called ZephyrTM Endobronchial Valve (EBV) (Emphasys Medical, Inc., Redwood City, CA)
Procedure under general anesthesia.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean % change in lung function (FEV1)
Measured: 90 days post index bronchoscopic lung volume reduction
Secondary outcomes (1)
Mean % change in target lobe Residual Volume and Total Lung Capacity. Mean absolute change in dyspnea (mMRC-Score), Quality of life using St. George's Respiratory Questionnaire and SF-36.
Measured: 90 days post-index bronchoscopic lung volume reduction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startJul 2007
- Primary completionSep 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmphysemaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology
- Sponsor type
- Research network
- Investigators
- Arschang Valipour, MD, Principal investigator, Ludwig Boltzmann Institute for COPD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730301
- Sponsor's protocol ID
- EUROPT 07-074-0507
- Acronym
- EUROPT
- Status last verified
- Aug 2008
- First submitted
- 5 Aug 2008
- Last updated
- 8 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Prospective, Clinical Trial Designed to Study the Efficacy of One-Way Valve Implantation Based on a New Treatment Algorithm in Patients With Heterogeneous Emphysema
- ClinicalTrials.gov ID
- NCT00730301
- Acronym / sponsor ID
- EUROPT / EUROPT 07-074-0507
- Conditions
- Emphysema, Chronic Obstructive Pulmonary Disease
- Keywords
- Emphysema, Chronic obstructive pulmonary disease, Lung volume reduction, Lung function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- LudwLudwig Boltzmann Institute for COPD and Respiratory EpidemiologyResearch network
- Study start
- Jul 2007
- Primary completion
- Sep 2008 (estimated)
- First posted
- 8 Aug 2008 (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.
The purpose of this study is to assess the efficacy of a new treatment algorithm for bronchoscopic lung volume reduction (BLVR) in patients with emphysema based on the information of emphysema heterogeneity, destruction score, and fissure analysis.
Detailed description
Emphysema is a progressive pulmonary disease characterized by abnormal and permanent enlargement of air spaces distal to terminal bronchioles accompanied by the destruction of pulmonary parenchyma. Treatment includes inhaled bronchodilator therapy, rehabilitation and/or oxygen treatment. In addition to the above, patients with severe emphysema may benefit from surgical lung volume reduction and/or lung transplantation. The rationale for lung volume reduction surgery is that reducing lung size would restore elastic recoil of the lung and improve chest wall and diaphragm mechanics. It has previously been shown that particularly patients with heterogeneous emphysema seem to benefit most from surgical lung volume reduction.
Bronchoscopic lung volume reduction (BLVR) has recently been introduced as a less invasive potential alternative to surgical lung volume reduction. BLVR attempts to achieve the effects of surgery, by placing bronchial prostheses using a fibreoptic bronchoscope to selectively occlude the airways supplying the most affected hyperinflated regions of the emphysematous lung, while permitting exhaled gas to escape. This attempts to achieve segmental or lobar volume reduction, simulating the effects of surgical LVR. Recent trials of BLVR using endobronchial one-way valves demonstrated significant improvements in lung function parameters, exercise capacity and quality of life in patients with end-stage emphysema. The treatment algorithm for valve implantations to achieve BLVR, however, varied considerably in these reports as well as clinical and functional response rates. Subset analysis of these studies revealed that particularly, but not exclusively, patients with radiological signs of lung volume reduction treated unilaterally showed significant clinical improvements, whereas most patients without signs of lung volume reduction did not experience these benefits. The present study investigates the response to BLVR based on a new treatment algorithm including lung function criteria and computed tomography of the thorax.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patient diagnosed by HRCT Core Lab with eligible heterogeneous disease distribution and at least one complete oblique fissure.
- Age from 40 to 75 years
- BMI < 32 kg/m2
- FEV1 < 40% of predicted value, FEV1/FVC < 70%
- TLC > 120% predicted, RV > 150% predicted.
Key exclusion criteria (19 listed)
- Prior endobronchial treatment for emphysema
- Pleural or interstitial disease that precludes surgery.
- Prior lung transplant, LVRS, median sternotomy, bullectomy or lobectomy.
- Clinically significant bronchiectasis
- Pulmonary nodule requiring surgery
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 |
|---|---|---|
| Bronchoscopic Lung Volume Reduction (BLVR)Also: ZephyrTM Endobronchial Valve (EBV) (Emphasys Medical, Inc., Redwood City, CA)Procedure under general anesthesia. | Procedure or surgery | – |
Primary outcome
Mean % change in lung function (FEV1)
Time frame: 90 days post index bronchoscopic lung volume reduction
1 secondary outcome
Mean % change in target lobe Residual Volume and Total Lung Capacity. Mean absolute change in dyspnea (mMRC-Score), Quality of life using St. George's Respiratory Questionnaire and SF-36.
Time frame: 90 days post-index bronchoscopic lung volume reduction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2008.
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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.
Arschang Valipour, MD principal investigator
Ludwig Boltzmann Institute for COPD
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bronchoscopic Lung Volume Reduction (BLVR) in people with Emphysema and Chronic Obstructive Pulmonary Disease, run by LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology at 3 sites in 2 countries.
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 13 inclusion and 19 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 8 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Austria. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Arschang Valipour, MD (+43-1-91060-41833, arschang.valipour@wienkav.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean % change in lung function (FEV1) (time frame: 90 days post index bronchoscopic lung volume reduction). 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 8 Aug 2008.