Heterogeneous EmphysemaPhase 2/3NCT01902732
Endoscopic Lung Volume Reduction After Catheter-based CV Measurement in Patients With Heterogeneous Emphysema and Complete Interlobar Fissures
A Phase 2/3 study testing Implantation of valves (IBV) in people with Heterogeneous Emphysema, run by Heidelberg University at 5 sites in Germany.
Trial summary
This clinical trial evaluates the impact of catheter-based measurement of interloabr collateral ventilation prior to endoscopic lung volume reduction in patients with hetereogeneous emphysema and complete interlobar fissures in high resolution computed tomography. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heterogeneous Emphysema
- What is being tested?
- Implantation of valves (IBV)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesGermany
- Study dates
- Jun 2013to Dec 2014
- Phase
- Phase 2/3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- written informed consent
- ability to understand the importance of adherence to study treatment and the study protocol and willing to follow all study requirements
- severe lung emphysema (FEV1<45%, RV>150%, TLC>100%)
- pO2>60 mmHg with 4l O2, pCO2 < 60 mmHg at rest
- heterogeneous lung emphysema diagnosed with HRCT and perfusion scintigraphy
- confirmed heterogeneity by YACTA®
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- disclosure of parallel channels through relevant interlobar fissures
- age > 30 years
- stable COPD without exacerbation 8 weeks prior to screening
- dose of cortisone< 20 mg prednisone or equivalent OCS
- non-smoker or ex-smoker who stopped smoking for at least 4 months prior to the screening visit
- current CoHb < 2,5%
Who cannot join
- BMI < 18 mg/kg2
- significant bronchiectasis with sputum production of 4 tablespoons/day
- 6-minute-walk distance < 150 m
- myocardial infarction within 6 weeks prior screening visit
- decompensated heart failure
- cardiomyopathy with moderate or severe restricted LVF
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- long-term medication with Clopidogrel
- status after lung resection (Lobectomy/Pneumonectomy)
- existing pregnancy
- female subjects of child-bearing potential without acceptable forms of contraception
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites, 5 recruiting
- Recruiting
LungenClinic Grosshansdorf
Großhansdorf, 22927
Klaus Rabe, k.f.rabe@ungenclinic.de
Rabe Klaus, Prof. Dr. med.
- Recruiting
LungenClinic Grosshansdorf
Großhansdorf, 22927
Henrik Watz, PD Dr. med., H.Watz@pulmoresearch.de
Henrik Watz, PD Dr. med.
- Recruiting
Thoraxklinik Heidelberg
Heidelberg, 69126
Daniela Gompelmann, MD, +49(0)62213968087, daniela.gompelmann@thoraxklinik-heidelberg.de
Daniela Gompelmann, MD
- Recruiting
Thoraxklinik Heidelberg
Heidelberg, 69126
Felix JF Herth, MD, +49 6221 396 ext. 1200, Felix.Herth@thoraxklinik-heidelberg.de
- Recruiting
Thoraxklinik
Heidelberg, 69126
Ralf Eberhardt, MD, +49 6221 396 ext. 8204, Ralf.Eberhardt@thoraxklinik-heidelberg.de
Ralf Eberhardt, MD
About this study
Official title: Bronchoscopic Volume Reduction With Valve Implants After Analysis of Interlobar Fissure Integrity and Measurement of Collateral Ventilation in Patients With Severe, Heterogeneous Emphysema
This clinical trial evaluates the impact of catheter-based measurement of interloabr collateral ventilation prior to endoscopic lung volume reduction in patients with hetereogeneous emphysema and complete interlobar fissures in high resolution computed tomography.
Read the detailed description
50 patients (25 per center) with heterogeneous lung emphysema with indication for endoscopic lung volume reduction by valve implantation will be prospectively included in the study. Heterogeneity of emphysema and fissure completeness of the relevant lobe will be proven from high resolution computed tomography (HRCT) prior to enrolment in the study. Fissure integrity will be analyzed by a core radiology. If fissure completeness is proved, patients will be enrolled in the study. All recruited patients will additionally receive a collateral ventilation measurement by using the Chartis® Pulmonary Assement System during a flexible bronchoscopy. Depending on the results of this measurement, patients are divided in two parallel arms: A: complete fissure integrity and low collateral ventilation (CV negative) B: complete fissure integrity and high collateral ventilation (CV positive) Following the CV measurement, each patient will receive valve therapy.
- Conditions
- Heterogeneous Emphysema
- Being tested
- Implantation of valves (IBV)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of valves (IBV)Device
Also called Spiration(R) valves
Implantation of intrabronchial valves in the most emphysematous destroyed and hyperinflated lung lobe improves the elastic recoisl of the samll airways by a reduction in lung volume and thus leading to more ergonomic breathing mechanics and diaphragm function. This positive effect is observed particularly in patients with low interlobar collateral ventilation that can be quantified by CT fissure analysis and/or catheter-based measurement.
| Study group | Role | What they receive |
|---|---|---|
| Implantation of valves (IBV) | Other | Following catheter-based measurement of collaertal ventilation, each patient is treated by a complete occlusion of the targeted lobe by intrabronchial valves. Receives: Device: Implantation of valves (IBV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement on pulmonary function
Development of lung function parameters FEV1 and RV/TLC. Increase of FEV1 of 15% and decrease of RV/TLC of 10% compared to baseline will be considered as clinically significant.
Measured: 12 months
Secondary outcomes (1)
Assessment of safety and efficacy
Safety:
- Evaluation of number of serious adverse events related to the treatment
- Evaluation of migration rate of valve implants
- Evaluation of technical difficulties during implantation of valves
Efficacy:
- average change in lung function (FEV1, IVC, RV, TLC, RV/TLC) 30 , 90, 180 and 365 days after ELVR
- average change in life quality (SGRQ) and in dyspnoea score (mMRC)
- average changes in distance of six minute walk test 30, 90, 180 and 365 days after ELVR
- average changes in physical activity at home, measured with Sensewear®-wristband for three days 30, 90, 180 and 360 days after ELVR
- echocardiographic/laboratory chemical changes of cardiac function 30, 90, 180 and 365 days after ELVR.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heterogeneous 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felix JF Herth, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01902732
- Sponsor's protocol ID
- Protocol G1.0.- 16.02.2012
- Status last verified
- Jul 2013
- First submitted
- 13 Jun 2013
- Last updated
- 18 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchoscopic Volume Reduction With Valve Implants After Analysis of Interlobar Fissure Integrity and Measurement of Collateral Ventilation in Patients With Severe, Heterogeneous Emphysema
- ClinicalTrials.gov ID
- NCT01902732
- Acronym / sponsor ID
- Protocol G1.0.- 16.02.2012
- Conditions
- Heterogeneous Emphysema
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2014 (estimated)
- First posted
- 18 Jul 2013 (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.
This clinical trial evaluates the impact of catheter-based measurement of interloabr collateral ventilation prior to endoscopic lung volume reduction in patients with hetereogeneous emphysema and complete interlobar fissures in high resolution computed tomography.
Detailed description
50 patients (25 per center) with heterogeneous lung emphysema with indication for endoscopic lung volume reduction by valve implantation will be prospectively included in the study. Heterogeneity of emphysema and fissure completeness of the relevant lobe will be proven from high resolution computed tomography (HRCT) prior to enrolment in the study. Fissure integrity will be analyzed by a core radiology. If fissure completeness is proved, patients will be enrolled in the study. All recruited patients will additionally receive a collateral ventilation measurement by using the Chartis® Pulmonary Assement System during a flexible bronchoscopy. Depending on the results of this measurement, patients are divided in two parallel arms: A: complete fissure integrity and low collateral ventilation (CV negative) B: complete fissure integrity and high collateral ventilation (CV positive) Following the CV measurement, each patient will receive valve therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implantation of valves (IBV) | Other | Device: Implantation of valves (IBV)Following catheter-based measurement of collaertal ventilation, each patient is treated by a complete occlusion of the targeted lobe by intrabronchial valves. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- written informed consent
- ability to understand the importance of adherence to study treatment and the study protocol and willing to follow all study requirements
- severe lung emphysema (FEV1<45%, RV>150%, TLC>100%)
- pO2>60 mmHg with 4l O2, pCO2 < 60 mmHg at rest
- heterogeneous lung emphysema diagnosed with HRCT and perfusion scintigraphy
Key exclusion criteria (10 listed)
- BMI < 18 mg/kg2
- significant bronchiectasis with sputum production of 4 tablespoons/day
- 6-minute-walk distance < 150 m
- myocardial infarction within 6 weeks prior screening visit
- decompensated heart failure
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 |
|---|---|---|
| Implantation of valves (IBV)Also: Spiration(R) valvesImplantation of intrabronchial valves in the most emphysematous destroyed and hyperinflated lung lobe improves the elastic recoisl of the samll airways by a reduction in lung volume and thus leading to more ergonomic breathing mechanics and diaphragm function. This positive effect is observed particularly in patients with low interlobar collateral ventilation that can be quantified by CT fissure analysis and/or catheter-based measurement. | Device | Implantation of valves (IBV) |
Primary outcome
Improvement on pulmonary function
Time frame: 12 months
Development of lung function parameters FEV1 and RV/TLC. Increase of FEV1 of 15% and decrease of RV/TLC of 10% compared to baseline will be considered as clinically significant.
1 secondary outcome
Assessment of safety and efficacy
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2013.
Related trials for Heterogeneous Emphysema
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.
Thoraxklinik Heidelberg
Heidelberg, Germany
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Implantation of valves (IBV) in people with Heterogeneous Emphysema, run by Heidelberg University at 5 sites 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 10 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 18 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement on pulmonary function (time frame: 12 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 18 Jul 2013.