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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03299764
• Other study ID #: DZL PBLV Trial
• Status: Suspended
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: July 1, 2027

Study information

• Verified date: April 2024
• Source: Research Center Borstel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 270
• Est. completion date: July 1, 2027
• Est. primary completion date: November 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD

Intervention

Device:
• Pursed lip breathing ventilation
A non-invasive ventilation device mimicking the pursed lip breathing in COPD patients will be used.
• Standard non-invasive ventilation
Standard non-invasive ventilation

Locations

Country	Name	City	State
Germany	Research Center Borstel	Borstel	Schleswig-Holstein
Germany	LungenClinic Großhansdorf	Großhansdorf	Schleswig-Holstein
Germany	Thoraxklinik Heidelberg	Heidelberg	Baden-Württemberg
Germany	Lungenklinik Hemer	Hemer
Germany	Waldburg-Zeil Kliniken - Fachkliniken Wangen	Wangen	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Research Center Borstel

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Walking distance in 6-minutes walking test		3 months
Secondary	Mortality		12 months
Secondary	Number of hospital admissions		12 months