Clinical trial NCT01902732: 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
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Heterogeneous Emphysema
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2013-07-18
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Improvement on pulmonary function
timeFrame: 12 months
Secondary outcomes:
measure: Assessment of safety and efficacy
timeFrame: 12 months
Other outcomes:
Locations:
city: Grosshansdorf
country: Germany
facility: LungenClinic Grosshansdorf
city: Großhansdorf
country: Germany
facility: LungenClinic Grosshansdorf
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg
city: Heidelberg
country: Germany
facility: Thoraxklinik
Study officials:
References: