Bronchioscopic Lung Volume Reduction (BLVR)

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)

• Registration Number: NCT02415478
• Lead Sponsor: RWTH Aachen University

Brief Summary

For patients with emphysema, lung volume reduction by insertion of endobronchial valves could be an expedient approach to improve the diaphragm function and the strength of breathing muscles. Therefore in the present study investigators intend to examine, whether the lung volume reduction by valves might improve the physical capacity and the quality of life.

Detailed Description

In line with routine explorations it is necessary to clarify whether a patient is suitable for the lung volume reduction by insertion of endobronchial valves. To address this question lung function diagnostics, 6-minutes-walk-test, blood withdrawal, CT of the thorax, lung perfusion scintigraphy and transthoracic echocardiography have to be performed.

After confirmation of the suitability for the endoscopic lung volume reduction patients who fulfill all other eligibility criteria will be educated about the aim and performance of the study by an investigator.

Following examination will be performed additional due to the study: determination of the strength of breathing muscles via sniff nasal pressure (PImax, PE max, P0.1), determination of the life quality index via St.-George-questionary and determination of the depression score via the Short Form 8 (SF-8) Health Survey.

After that endobronchial valve will be implanted and a permanent post-operative examination will be performed for 24 hours.

Three, respectively nine month after the implanting follow up exploration will be performed on the study patients. Once again the determination of the strength of breathing muscles, the life quality index via St.-George-questionary and the depression score via SF-8 will be performed to clarify an improvement of the physical capacity and the quality of life

Study Timeline

• Study First Submitted: 2015-03-20
• Study First Submitted QC: 2015-04-08
• Study First Posted: 2015-04-14
• Study Start: 2015-09
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-18
• Last Update Posted: 2015-11-20
• Primary Completion: 2016-09
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• bilateral lung emphysema after CT
• previous guidelines-based therapy of COPD (including vaccinations against Pneumococcal infections and seasonal influenza)
• nicotine abstention for not less than three months, documented by CO-HB (haemoglobin) < 2%
• FEV 1 (Forced Expiratory Volume 1 / one second capacity) ≤ 45% of reference value, after bronchodilatation
• total lung capacity (TLC) ≥ 100% of reference value
• residual volume (RV) ≥ 175% of reference value
• patient's suitability for endoscopic lung volume reduction according to multidisciplinary decision of pneumology and thorax surgery division.
• signed Informed Consent
• understanding of the nature, significance and implications of the study
• ability to understand and follow instructions of the study stuff

Exclusion Criteria

• echo-cardiographic right ventricular pressure (PAPsys) > 50 mmHg
• indication for a permanent anticoagulation therapy (besides ASS)
• pulmonal cachexia
• pregnancy and lactating
• permanent treatment with > 20 mg Prednison per day
• hospitalisation due to a COPD-exacerbation in the last 3 months
• > 3 steroid-treated exacerbations in the last year
• Increase of FEV1 (Forced Expiratory Volume) ≥ 20% after bronchodilatation
• severe diffusion impairment (DLCO < 20%)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Breath Muscle Power	Change of breathing strength 3 (respectively 9) months after the bronchoscopy	Sniff nasal pressure

Trial Locations

Locations (1)

RWTH Univerity Hospital, Department of Cardiology, Pneumology, Vascular Medicine and Intensive Care Medicine; 🇩🇪 Aachen, Germany