COPDPLBNCT04663698
The Effect of Volitional Pursed-lips Breathing
A study testing Baseline, MESH-Resistor 5 and MESH-Resistor 10 in people with COPD, run by Karl Josef Franke, PD DR med at 1 site in Germany.
Trial summary
Simulation of pursed-lips breathing by defined stenoses in pulmonary function diagnostics to quantify the effect of the pursed-lips breathing Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD
- What is being tested?
- Baseline, MESH-Resistor 5 and MESH-Resistor 10
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteGermany
- Study dates
- 11 Sep 2019to 30 Mar 2021
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients:
- COPD (GOLD I- IV)
- Stable respiratory situation that allows routine lung funtion
- capable of communication
- Healthy:
- Lung Healthy
- capable of communication
Who cannot join
- Invasive Ventilation
- Other serious acute physical illnesses that require immediate intensive medical treatment
- Acute hypercapnic decompensation with a pH < 7.35 in the capillary BGA
- Pregnancy or Nursing
- Not able to give consent
- Not willing or able to follow the study protocol
Trial locations and contacts
1 site in 1 country.
Germany1 site
Märkische Kliniken GmbH, Klinikum Lüdenscheid
Lüdenscheid, North Rhine-Westphalia, 58515
About this study
Official title: Evaluation of PLB Physiology in COPD - Untersuchung Zur Physiologie Der Lippenbremse Bei COPD
Simulation of pursed-lips breathing by defined stenoses in pulmonary function diagnostics to quantify the effect of the pursed-lips breathing
Read the detailed description
Since many years it is recommended for COPD patients to reduce the crossdiameter of the lips in order to improve the exhalation by means of so-called pursed-lips breathing (PLB). But the effects have never been studied quantitatively. In this study, the PLB effect is simulated during lung function diagnostics, using different sized resistors inserted into the routine mouthpiece of the flow sensor to resemble the effective airway resistances of a PLB maneuver. This prospective, randomized study includes 20 healthy subjects and 50 COPD patients, who will perform lung function testing with 4 different sized resistors.
- Conditions
- COPD
- Being tested
- Baseline, MESH-Resistor 5, MESH-Resistor 10, Perforated Resistor 7, Perforated Resistor 11
- Keywords
- Pursed-lips Breathing, Resistor
- 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.
BaselineOther
Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH
MESH-Resistor 5Other
Also called Rudolph Flow Resistance Standards; HANS RUDOLPH, Inc.
Lung funtion testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with mesh-resistor (5hPa/L) to create laminar airflow
MESH-Resistor 10Other
Also called Rudolph Flow Resistance Standards; HANS RUDOLPH, inc
Lung funtion testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with mesh-resistor (10hPa/L) to create laminar airflow
Perforated Resistor 7Other
Also called 900MR405; Fisher&Paykel Healthcare
Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with perforated resistor (inside diameter 7mm) to create a turbulent airflow
Perforated Resistor 11Other
Also called 900MR406; Fisher&Paykel Healthcare
Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with perforated resistor (inside diameter 11mm) to create a turbulent airflow
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Experimental | Lung-healthy subjects, randomized lung function testing Receives: Other: Baseline; Other: MESH-Resistor 5; Other: MESH-Resistor 10; Other: Perforated Resistor 7; Other: Perforated Resistor 11 |
| Patient 1 | Experimental | COPD patients, randomized lung function testing Receives: Other: Baseline; Other: MESH-Resistor 5; Other: MESH-Resistor 10 |
| Patient 2 | Experimental | COPD patients, randomized lung function testing Receives: Other: Baseline; Other: Perforated Resistor 7; Other: Perforated Resistor 11 |
| Patient 3 | Experimental | COPD patients, randomized lung function testing Receives: Other: Baseline; Other: MESH-Resistor 5; Other: Perforated Resistor 7 |
| Patient 4 | Experimental | COPD patients, randomized lung function testing Receives: Other: Baseline; Other: MESH-Resistor 5; Other: Perforated Resistor 11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung function parameter FEV1
Measuring of lung function parameters with different resistors to simulate PLB unit: L, measured with der MasterScreen™ Body, CareFusion
Measured: up to 1 hour
Secondary outcomes (2)
PEF - expiratory Peak Flow
unit: L, measured with der MasterScreen™ Body, CareFusion
Measured: up to 1 hour
RV%TLC
unit: %, measured with der MasterScreen™ Body, CareFusion
Measured: up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start11 Sep 2019
- Primary completion8 Jan 2021
- Study completion30 Mar 2021
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karl Josef Franke, PD DR med
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Karl Josef Franke, PD DR med, Institut für Pneumologie Hagen Ambrock eV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663698
- Sponsor's protocol ID
- PLB2019
- Acronym
- PLB
- Status last verified
- Sep 2021
- First submitted
- 22 Oct 2020
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of PLB Physiology in COPD - Untersuchung Zur Physiologie Der Lippenbremse Bei COPD
- ClinicalTrials.gov ID
- NCT04663698
- Acronym / sponsor ID
- PLB / PLB2019
- Conditions
- COPD
- Keywords
- Pursed-lips Breathing, Resistor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Karl Josef Franke, PD DR medIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2019 (actual)
- Primary completion
- 8 Jan 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 11 Dec 2020 (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.
Simulation of pursed-lips breathing by defined stenoses in pulmonary function diagnostics to quantify the effect of the pursed-lips breathing
Detailed description
Since many years it is recommended for COPD patients to reduce the crossdiameter of the lips in order to improve the exhalation by means of so-called pursed-lips breathing (PLB). But the effects have never been studied quantitatively. In this study, the PLB effect is simulated during lung function diagnostics, using different sized resistors inserted into the routine mouthpiece of the flow sensor to resemble the effective airway resistances of a PLB maneuver. This prospective, randomized study includes 20 healthy subjects and 50 COPD patients, who will perform lung function testing with 4 different sized resistors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy | Experimental | Other: Baseline, Other: MESH-Resistor 5, Other: MESH-Resistor 10, Other: Perforated Resistor 7, Other: Perforated Resistor 11Lung-healthy subjects, randomized lung function testing |
| Patient 1 | Experimental | Other: Baseline, Other: MESH-Resistor 5, Other: MESH-Resistor 10COPD patients, randomized lung function testing |
| Patient 2 | Experimental | Other: Baseline, Other: Perforated Resistor 7, Other: Perforated Resistor 11COPD patients, randomized lung function testing |
| Patient 3 | Experimental | Other: Baseline, Other: MESH-Resistor 5, Other: Perforated Resistor 7COPD patients, randomized lung function testing |
| Patient 4 | Experimental | Other: Baseline, Other: MESH-Resistor 5, Other: Perforated Resistor 11COPD patients, randomized lung function testing |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- COPD (GOLD I- IV)
- Stable respiratory situation that allows routine lung funtion
- capable of communication
- Lung Healthy
- capable of communication
Key exclusion criteria (6 listed)
- Invasive Ventilation
- Other serious acute physical illnesses that require immediate intensive medical treatment
- Acute hypercapnic decompensation with a pH < 7.35 in the capillary BGA
- Pregnancy or Nursing
- Not able to give consent
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 |
|---|---|---|
| BaselineLung function testing with MasterScreen™ Body, CareFusion Germany GmbH | Other | Healthy, Patient 1, Patient 2, Patient 3, Patient 4 |
| MESH-Resistor 5Also: Rudolph Flow Resistance Standards; HANS RUDOLPH, Inc.Lung funtion testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with mesh-resistor (5hPa/L) to create laminar airflow | Other | Healthy, Patient 1, Patient 3, Patient 4 |
| MESH-Resistor 10Also: Rudolph Flow Resistance Standards; HANS RUDOLPH, incLung funtion testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with mesh-resistor (10hPa/L) to create laminar airflow | Other | Healthy, Patient 1 |
| Perforated Resistor 7Also: 900MR405; Fisher&Paykel HealthcareLung function testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with perforated resistor (inside diameter 7mm) to create a turbulent airflow | Other | Healthy, Patient 2, Patient 3 |
| Perforated Resistor 11Also: 900MR406; Fisher&Paykel HealthcareLung function testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with perforated resistor (inside diameter 11mm) to create a turbulent airflow | Other | Healthy, Patient 2, Patient 4 |
Primary outcome
Lung function parameter FEV1
Time frame: up to 1 hour
Measuring of lung function parameters with different resistors to simulate PLB unit: L, measured with der MasterScreen™ Body, CareFusion
2 secondary outcomes
PEF - expiratory Peak Flow
Time frame: up to 1 hour
RV%TLC
Time frame: up to 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline, MESH-Resistor 5 and MESH-Resistor 10 in people with COPD, run by Karl Josef Franke, PD DR med 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 14 Sep 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Lung function parameter FEV1 (time frame: up to 1 hour). 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 14 Sep 2021.