COPDNCT03299764
Evaluation of Non-invasive Pursed-lip Breathing Ventilation (PLBV) in Advanced COPD
A study testing Pursed lip breathing ventilation and Standard non-invasive ventilation in people with COPD, run by Research Center Borstel at 5 sites in Germany.
Trial summary
Comparison of a conventional non-invasive ventilation to a non-invasive pursed-lip breathing ventilation (PLBV) ventilation in advanced COPD Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Pursed lip breathing ventilation and Standard non-invasive ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 5 sitesGermany
- Study dates
- 1 Nov 2017to 1 Jul 2027
- Phase
- Interventional
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Age >40 years
- COPD diagnosis known for at least 12 months
- NIV therapy for at least 3 months
- 4. Regular use of NIV with extrapolated usage time of at least 700 hours / year 5. Current inspiratory NIV pressure ≥20 mbar 6. Patient understands the requirements of the study 7. Patient is able to follow the study protocol
Who cannot join
- Current COPD exacerbation (is allowed 4 weeks after end of treatment)
- Radiologically proven pneumonia within the past month
- Other leading pulmonary illness
- Tracheostomy
- Pneumothorax
- Pregnancy or lactation
Show all 13Show fewer
- BMI >35 kg/m²
- Steroid therapy with >15 mg prednisolon daily for >1 month
- Condition causing hypercapnia other than COPD
- 6MWT distance of >300 meters within the last 7 days
- Previous therapy with the Vigaro NIV device
- Weight loss of more than 5 kg / 12 months
- Further criteria to exclude confounding factors
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Research Center Borstel
Borstel, Schleswig-Holstein, 23845
LungenClinic Großhansdorf
Großhansdorf, Schleswig-Holstein, 22937
Thoraxklinik Heidelberg
Heidelberg, Baden-Wurttemberg, 69126
Lungenklinik Hemer
Hemer, 58675
Waldburg-Zeil Kliniken - Fachkliniken Wangen
Wangen, Baden-Wurttemberg, 88239
About this study
Comparison of a conventional non-invasive ventilation to a non-invasive pursed-lip breathing ventilation (PLBV) ventilation in advanced COPD
Read the detailed description
Intervention:
Non-invasive ventilation with dynamic positive pressure during expiration (pursed-lip breathing ventilation, PLBV) Control Conventional bi-level non-invasive ventilation (NIV) with static positive pressures Duration of intervention per patient 3 months as randomized (1:1) followed by 9 months as chosen by patient
- Conditions
- COPD
- Being tested
- Pursed lip breathing ventilation, Standard non-invasive ventilation
- 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.
Pursed lip breathing ventilationDevice
A non-invasive ventilation device mimicking the pursed lip breathing in COPD patients will be used.
Standard non-invasive ventilationDevice
Standard non-invasive ventilation
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Non-invasive ventilation with pursed lip breathing ventilation device Receives: Device: Pursed lip breathing ventilation |
| Control | Active comparator | Non-invasive ventilation with standard non-invasive ventilation device Receives: Device: Standard non-invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking distance in 6-minutes walking test
Measured: 3 months
Secondary outcomes (2)
Mortality
Measured: 12 months
Number of hospital admissions
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start1 Nov 2017
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Why it stopped: Devices not available at the moment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Center Borstel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299764
- Sponsor's protocol ID
- DZL PBLV Trial
- Status last verified
- Apr 2024
- First submitted
- 27 Sep 2017
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Non-invasive Pursed-lip Breathing Ventilation (PLBV) in Advanced COPD
- ClinicalTrials.gov ID
- NCT03299764
- Acronym / sponsor ID
- DZL PBLV Trial
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Devices not available at the moment.
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Research Center BorstelUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 3 Oct 2017 (actual)
- 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.
Comparison of a conventional non-invasive ventilation to a non-invasive pursed-lip breathing ventilation (PLBV) ventilation in advanced COPD
Detailed description
Intervention:
Non-invasive ventilation with dynamic positive pressure during expiration (pursed-lip breathing ventilation, PLBV) Control Conventional bi-level non-invasive ventilation (NIV) with static positive pressures Duration of intervention per patient 3 months as randomized (1:1) followed by 9 months as chosen by patient
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Pursed lip breathing ventilationNon-invasive ventilation with pursed lip breathing ventilation device |
| Control | Active comparator | Device: Standard non-invasive ventilationNon-invasive ventilation with standard non-invasive ventilation device |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent
- Age >40 years
- COPD diagnosis known for at least 12 months
- NIV therapy for at least 3 months
- 4. Regular use of NIV with extrapolated usage time of at least 700 hours / year 5. Current inspiratory NIV pressure ≥20 mbar 6. Patient understands the requirements of the study 7. Patient is able to follow the study protocol
Key exclusion criteria (13 listed)
- Current COPD exacerbation (is allowed 4 weeks after end of treatment)
- Radiologically proven pneumonia within the past month
- Other leading pulmonary illness
- Tracheostomy
- Pneumothorax
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 |
|---|---|---|
| Pursed lip breathing ventilationA non-invasive ventilation device mimicking the pursed lip breathing in COPD patients will be used. | Device | Intervention |
| Standard non-invasive ventilationStandard non-invasive ventilation | Device | Control |
Primary outcome
Walking distance in 6-minutes walking test
Time frame: 3 months
2 secondary outcomes
Mortality
Time frame: 12 months
Number of hospital admissions
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pursed lip breathing ventilation and Standard non-invasive ventilation in people with COPD, run by Research Center Borstel at 5 sites 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 5 inclusion and 13 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: paused, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking distance in 6-minutes walking test (time frame: 3 months). 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 12 Apr 2024.