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

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

Study Overview

• Status: Suspended
• Conditions: COPD
• Intervention / Treatment: Device: Pursed lip breathing ventilation; Device: Standard non-invasive ventilation

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 Type: Interventional
• Enrollment (Estimated): 270
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hemer, Germany, 58675
    • Lungenklinik Hemer
  • Baden-Württemberg
    • Heidelberg, Baden-Württemberg, Germany, 69126
      • Thoraxklinik Heidelberg
    • Wangen, Baden-Württemberg, Germany, 88239
      • Waldburg-Zeil Kliniken - Fachkliniken Wangen
  • Schleswig-Holstein
    • Borstel, Schleswig-Holstein, Germany, 23845
      • Research Center Borstel
    • Großhansdorf, Schleswig-Holstein, Germany, 22937
      • LungenClinic Grosshansdorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Mortality	12 months
Number of hospital admissions	12 months

Collaborators and Investigators

• Sponsor: Research Center Borstel

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: September 27, 2017
• First Submitted That Met QC Criteria: September 27, 2017
• First Posted (Actual): October 3, 2017

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: DZL PBLV Trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No