Chronic Obstructive Pulmonary Disease (COPD)BLVRNCT02415478
Bronchioscopic Lung Volume Reduction (BLVR)
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by RWTH Aachen University at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- endoscopic lung volume reduction by valves
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2015to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with severe COPD (GOLD stage III or IV)
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- > 3 steroid-treated exacerbations in the last year
- Increase of FEV1 (Forced Expiratory Volume) ≥ 20% after bronchodilatation
- severe diffusion impairment (DLCO < 20%)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
RWTH Univerity Hospital, Department of Cardiology, Pneumology, Vascular Medicine and Intensive Care Medicine
Aachen, 52074
Michael Dreher, Univ.-Prof., +492418088763, mdreher@ukaachen.de
Tobias Müller, PD Dr.med., +492418088763, tobmueller@ukaachen.de
About this study
Official title: The Effect of Endoscopic Lung Volume Reduction Via Endobronchial Valves on Breath Muscle Power by Patients With COPD
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.
Read the 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
- Being tested
- endoscopic lung volume reduction by valves
- Keywords
- Chronic obstructive pulmonary disease (COPD), endoscopic lung volume reduction, Endobronchial valve, physical capacity, quality of life
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic lung volume reduction by valvesOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Breath Muscle Power
Maximal Inspiratory Pressure (PImax)
Measured: Change of breathing strength 3 (respectively 9) months after the bronchoscopy
Breath Muscle Power
Maximal Expiratory Pressure (PEmax)
Measured: Change of breathing strength 3 (respectively 9) months after the bronchoscopy
Breath Muscle Power
Neuromuscular drive (P0.1)
Measured: Change of breathing strength 3 (respectively 9) months after the bronchoscopy
Breath Muscle Power
Sniff nasal pressure
Measured: Change of breathing strength 3 (respectively 9) months after the bronchoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Dreher, Univ.-Prof., Principal investigator, RWTH University Hospital MK1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415478
- Sponsor's protocol ID
- 14-002
- Acronym
- BLVR
- Status last verified
- Nov 2015
- First submitted
- 20 Mar 2015
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Endoscopic Lung Volume Reduction Via Endobronchial Valves on Breath Muscle Power by Patients With COPD
- ClinicalTrials.gov ID
- NCT02415478
- Acronym / sponsor ID
- BLVR / 14-002
- Keywords
- Chronic obstructive pulmonary disease (COPD), endoscopic lung volume reduction, Endobronchial valve, physical capacity, quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 14 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with severe COPD (GOLD stage III or IV)
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopic lung volume reduction by valvesIndependent 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. | Other | – |
Primary outcome
Breath Muscle Power
Time frame: Change of breathing strength 3 (respectively 9) months after the bronchoscopy
Maximal Inspiratory Pressure (PImax)
Breath Muscle Power
Time frame: Change of breathing strength 3 (respectively 9) months after the bronchoscopy
Maximal Expiratory Pressure (PEmax)
Breath Muscle Power
Time frame: Change of breathing strength 3 (respectively 9) months after the bronchoscopy
Neuromuscular drive (P0.1)
Breath Muscle Power
Time frame: Change of breathing strength 3 (respectively 9) months after the bronchoscopy
Sniff nasal pressure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
Related trials for Chronic Obstructive Pulmonary Disease (COPD)
Recruiting
Rehabilitation in Safety-net Environments (RISE) to Improve Outcomes in Vulnerable Patients With COPD
COPD (Chronic Obstructive Pulmonary Disease)
RecruitingObservational study
Characteristics and Outcomes of Patients Admitted to ICU for a Severe Acute Exacerbation of COPD.
COPD Exacerbation, ICU
RecruitingPhase 4
Genetic Variation in IgG in Alpha 1 Antitrypsin Deficiency
Alpha 1-Antitrypsin, COPD
RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
RecruitingObservational study
Comparing Advanced Technologies to Standard Testing for the Diagnosis of Airway Disease in Hospital and Community Settings
COPD (Chronic Obstructive Pulmonary Disease), Airway Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Dreher, Univ.-Prof. principal investigator
RWTH University Hospital MK1
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Dreher, Univ.-Prof. (+49241 80 88763, mdreher@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breath Muscle Power (time frame: Change of breathing strength 3 (respectively 9) months after the bronchoscopy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015; AzTrials last refreshed its copy on 28 Oct 2026.