Evaluation of Non-invasive Pursed-lip Breathing Ventilation (PLBV) in Advanced COPD

Study Overview
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Brief Summary
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Comparison of a conventional non-invasive ventilation to a non-invasive pursed-lip breathing ventilation (PLBV) ventilation in advanced COPD

Detailed Description
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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

Official Title
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Evaluation of Non-invasive Pursed-lip Breathing Ventilation (PLBV) in Advanced COPD

Conditions
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COPD

Intervention / Treatment
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* Device: Pursed lip breathing ventilation
* Device: Standard non-invasive ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Non-invasive ventilation with pursed lip breathing ventilation device | Device: Pursed lip breathing ventilation<br>* A non-invasive ventilation device mimicking the pursed lip breathing in COPD patients will be used.<br>|
| Active Comparator: Control<br>Non-invasive ventilation with standard non-invasive ventilation device | Device: Standard non-invasive ventilation<br>* Standard non-invasive ventilation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking distance in 6-minutes walking test |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 12 months | 
| Number of hospital admissions |  | 12 months |