Bronchioscopic Lung Volume Reduction (BLVR)

Status Recruiting

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.

Clinical Trial 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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

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

Clinical Trial Details

NCT number	NCT02415478
Study type	Observational
Source	RWTH Aachen University
Contact	Michael Dreher, Univ.-Prof.
Phone	+49241 80 88763
Email	mdreher@ukaachen.de
Status	Recruiting
Phase	N/A
Start date	September 2015
Completion date	December 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03282019` - Study of Long-term HFNC for COPD Patients With HOT	N/A
Completed	`NCT05573464` - A Study to Assess the Safety of Budesonide/Glycopyrronium/Formoterol Fumarate With the Hydrofluoroolefin Propellant in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease	Phase 3
Recruiting	`NCT06040086` - Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations	Phase 3
Not yet recruiting	`NCT06376994` - Multi-Center Clean Air Randomized Controlled Trial in COPD	Phase 3
Completed	`NCT02797392` - Feasibility of a Preventive Program Against Lifestyle Related Diseases	N/A
Completed	`NCT02926534` - Cross-Sectional Study of COPD Prevalence Among Smokers, Ex-smokers and Never-Smokers in Almaty, Kazakhstan	N/A
Completed	`NCT02728674` - Management of Patients With Respiratory Symptoms in Sweden	N/A
Completed	`NCT02512510` - Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)	Phase 3
Completed	`NCT03487406` - Anti-platelet Therapy in the Prevention of Cardiovascular Disease in Patients With COPD (APPLE-COPD: ICON 2)	Phase 2
Completed	`NCT02459080` - Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)	Phase 3
Completed	`NCT02774226` - Long Term Nitric Oxide Bioavailability on Vascular Health in Chronic Obstructive Pulmonary Disease	Phase 2
Completed	`NCT02518139` - A 52-Week Parallel Group Safety Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)	Phase 3
Completed	`NCT01908140` - Study of Aclidinium Bromide/Formoterol Fumarate Compared With Salmeterol/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)	Phase 3
Completed	`NCT01615484` - Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability	N/A
Completed	`NCT01893476` - A Pragmatic Cluster Trial of a Tailored Intervention to Improve COPD Management	N/A
Withdrawn	`NCT01908933` - Study of the AeriSeal System Treatment in Patients With Advanced Non-Upper Lobe Predominant Heterogeneous Emphysema	Phase 3
Completed	`NCT01701869` - Microbiology & Immunology of the Chronically-inflamed Airway	N/A
Recruiting	`NCT02527486` - Seoul National University Airway Registry	N/A
Terminated	`NCT01388920` - Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting	Phase 2
Withdrawn	`NCT01377428` - Efficacy of Indacaterol 150 µg Versus Formoterol	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Bronchioscopic Lung Volume Reduction (BLVR) — BLVR

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms