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

Heterogeneous Emphysema Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01902732
• Other study ID #: Protocol G1.0.- 16.02.2012
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: June 13, 2013
• Last updated: July 15, 2013
• Start date: June 2013

Study information

• Verified date: July 2013
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emphysema
• Heterogeneous Emphysema
• Pulmonary Emphysema

Intervention

Device:
• Implantation of valves (IBV)
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.

Locations

Country	Name	City	State
Germany	LungenClinic Grosshansdorf	Grosshansdorf
Germany	LungenClinic Grosshansdorf	Großhansdorf
Germany	Thoraxklinik	Heidelberg
Germany	Thoraxklinik Heidelberg	Heidelberg
Germany	Thoraxklinik Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months	No
Secondary	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.	12 months	Yes