Bronchioscopic Lung Volume Reduction (BLVR)

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— BLVR  

Official title:

The Effect of Endoscopic Lung Volume Reduction Via Endobronchial Valves on Breath Muscle Power by Patients With COPD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02415478
• Other study ID #: 14-002
• Status: Recruiting
• Phase: N/A
• First received: March 20, 2015
• Last updated: November 18, 2015
• Start date: September 2015
• Est. completion date: December 2016

Study information

• Verified date: November 2015
• Source: RWTH Aachen University
• Contact: Michael Dreher, Univ.-Prof.
• Phone: +49241 80 88763
• Email: mdreher[@]ukaachen.de
• Is FDA regulated: No
• Health authority: Germany: Bezirksregierung Köln, Dezernat 24
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• endoscopic lung volume reduction by valves
Independent of the study, subject will get a bronchoscopy with chartis measurement in general anaesthesia. chartis measurement is a Balloon angioplasty. Balloon will be well-positioned in lung and filled by air for occlusion of lobe of the lung. System recognizes collateral ventilation of lobe of the lung via calculation of airflow resistance. Negative result allows the endoscopic placement of selfexpandig endobronchial valves in the subject lung. Inhale airflow will be inhibit an enclosed air and liquids can exhaust.

Locations

Country	Name	City	State
Germany	RWTH Univerity Hospital, Department of Cardiology, Pneumology, Vascular Medicine and Intensive Care Medicine	Aachen

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breath Muscle Power	Maximal Inspiratory Pressure (PImax)	Change of breathing strength 3 (respectively 9) months after the bronchoscopy	No
Primary	Breath Muscle Power	Maximal Expiratory Pressure (PEmax)	Change of breathing strength 3 (respectively 9) months after the bronchoscopy	No
Primary	Breath Muscle Power	Neuromuscular drive (P0.1)	Change of breathing strength 3 (respectively 9) months after the bronchoscopy	No
Primary	Breath Muscle Power	Sniff nasal pressure	Change of breathing strength 3 (respectively 9) months after the bronchoscopy	No