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

Phase 2

• Conditions: Heterogeneous Emphysema
• Interventions: Device: Implantation of valves (IBV)

• Registration Number: NCT01902732
• Lead Sponsor: Heidelberg University

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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-13
• Status Verified: 2013-07
• Study First Submitted QC: 2013-07-15
• Last Update Submitted: 2013-07-15
• Study First Posted: 2013-07-18
• Last Update Posted: 2013-07-18
• Primary Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Implantation of valves (IBV)	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.

Primary Outcome Measures

Name	Time	Method
Improvement on pulmonary function	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.

Secondary Outcome Measures

Name	Time	Method
Assessment of safety and efficacy	12 months	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.

Trial Locations

Locations (3)

Thoraxklinik; 🇩🇪 Heidelberg, Germany

LungenClinic Grosshansdorf; 🇩🇪 Großhansdorf, Germany

Thoraxklinik Heidelberg; 🇩🇪 Heidelberg, Germany