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

Status

Suspended

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03299764

Enrollment

270

Registered

2017-10-03

Start date

2017-11-01

Completion date

2027-07-01

Last updated

2024-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Brief summary

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

Interventions

DEVICEPursed lip breathing ventilation

A non-invasive ventilation device mimicking the pursed lip breathing in COPD patients will be used.

DEVICEStandard non-invasive ventilation

Standard non-invasive ventilation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Signed informed consent 2. Age \>40 years 3. COPD diagnosis known for at least 12 months 4. 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

1. Current COPD exacerbation (is allowed 4 weeks after end of treatment) 2. Radiologically proven pneumonia within the past month 3. Other leading pulmonary illness 4. Tracheostomy 5. Pneumothorax 6. Pregnancy or lactation 7. BMI \>35 kg/m² 8. Steroid therapy with \>15 mg prednisolon daily for \>1 month 9. Condition causing hypercapnia other than COPD 10. 6MWT distance of \>300 meters within the last 7 days 11. Previous therapy with the Vigaro NIV device 12. Weight loss of more than 5 kg / 12 months 13. Further criteria to exclude confounding factors

Design outcomes

Primary

Measure	Time frame
Walking distance in 6-minutes walking test	3 months

Secondary

Measure	Time frame
Mortality	12 months
Number of hospital admissions	12 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026