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Endoscopic Lung Volume Reduction After Catheter-based CV Measurement in Patients With Heterogeneous Emphysema and Complete Interlobar Fissures

Primary Purpose

Heterogeneous Emphysema

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Implantation of valves (IBV)
Sponsored by
Heidelberg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heterogeneous Emphysema

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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®
  • 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%

Exclusion Criteria:

  • 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
  • long-term medication with Clopidogrel
  • status after lung resection (Lobectomy/Pneumonectomy)
  • existing pregnancy
  • female subjects of child-bearing potential without acceptable forms of contraception

Sites / Locations

  • LungenClinic GrosshansdorfRecruiting
  • LungenClinic GrosshansdorfRecruiting
  • Thoraxklinik HeidelbergRecruiting
  • Thoraxklinik HeidelbergRecruiting
  • ThoraxklinikRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Implantation of valves (IBV)

Arm Description

Following catheter-based measurement of collaertal ventilation, each patient is treated by a complete occlusion of the targeted lobe by intrabronchial valves.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 13, 2013
Last Updated
July 15, 2013
Sponsor
Heidelberg University
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1. Study Identification

Unique Protocol Identification Number
NCT01902732
Brief Title
Endoscopic Lung Volume Reduction After Catheter-based CV Measurement in Patients With Heterogeneous Emphysema and Complete Interlobar Fissures
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heterogeneous Emphysema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Implantation of valves (IBV)
Arm Type
Other
Arm Description
Following catheter-based measurement of collaertal ventilation, each patient is treated by a complete occlusion of the targeted lobe by intrabronchial valves.
Intervention Type
Device
Intervention Name(s)
Implantation of valves (IBV)
Other Intervention Name(s)
Spiration(R) valves
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement on pulmonary function
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Assessment of safety and efficacy
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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® 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% Exclusion Criteria: 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 long-term medication with Clopidogrel status after lung resection (Lobectomy/Pneumonectomy) existing pregnancy female subjects of child-bearing potential without acceptable forms of contraception
Facility Information:
Facility Name
LungenClinic Grosshansdorf
City
Grosshansdorf
ZIP/Postal Code
22927
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Klaus Rabe
Email
k.f.rabe@ungenclinic.de
First Name & Middle Initial & Last Name & Degree
Rabe Klaus, Prof. Dr. med.
Facility Name
LungenClinic Grosshansdorf
City
Großhansdorf
ZIP/Postal Code
22927
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henrik Watz, PD Dr. med.
Email
H.Watz@pulmoresearch.de
First Name & Middle Initial & Last Name & Degree
Henrik Watz, PD Dr. med.
Facility Name
Thoraxklinik Heidelberg
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Gompelmann, MD
Phone
+49(0)62213968087
Email
daniela.gompelmann@thoraxklinik-heidelberg.de
First Name & Middle Initial & Last Name & Degree
Daniela Gompelmann, MD
Facility Name
Thoraxklinik Heidelberg
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felix JF Herth, MD
Phone
+49 6221 396
Ext
1200
Email
Felix.Herth@thoraxklinik-heidelberg.de
Facility Name
Thoraxklinik
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ralf Eberhardt, MD
Phone
+49 6221 396
Ext
8204
Email
Ralf.Eberhardt@thoraxklinik-heidelberg.de
First Name & Middle Initial & Last Name & Degree
Ralf Eberhardt, MD

12. IPD Sharing Statement

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Endoscopic Lung Volume Reduction After Catheter-based CV Measurement in Patients With Heterogeneous Emphysema and Complete Interlobar Fissures

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