Clinical trial NCT02415478: Bronchioscopic Lung Volume Reduction (BLVR)
Official title: The Effect of Endoscopic Lung Volume Reduction Via Endobronchial Valves on Breath Muscle Power by Patients With COPD
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic obstructive pulmonary disease (COPD)
endoscopic lung volume reduction
Endobronchial valve
physical capacity
quality of life
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2015-04-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with severe COPD (GOLD stage III or IV)

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

Eligibility criteria: 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%)

Primary outcomes:
measure: Breath Muscle Power
timeFrame: Change of breathing strength 3 (respectively 9) months after the bronchoscopy
measure: Breath Muscle Power
timeFrame: Change of breathing strength 3 (respectively 9) months after the bronchoscopy
measure: Breath Muscle Power
timeFrame: Change of breathing strength 3 (respectively 9) months after the bronchoscopy
measure: Breath Muscle Power
timeFrame: Change of breathing strength 3 (respectively 9) months after the bronchoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: RWTH Univerity Hospital, Department of Cardiology, Pneumology, Vascular Medicine and Intensive Care Medicine
Study officials:
affiliation: RWTH University Hospital MK1
name: Michael Dreher, Univ.-Prof.
role: PRINCIPAL_INVESTIGATOR
References: