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SuspendedNCT03299764Updated Apr 12, 2024

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

An interventional study of Pursed lip breathing ventilation and Standard non-invasive ventilation in COPD, sponsored by Research Center Borstel. Suspended at 5 sites in Germany. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2024-04-12.

Sponsored by Research Center Borstel · Not applicable, Interventional, and Treatment

Why this study was suspended
Devices not available at the moment.
Phase
Not applicable
Study type
Interventional
Enrollment
270
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • COPD
03

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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
  1. 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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
270 participants (estimated)

Study arms

  • Experimental
    Intervention

    Non-invasive ventilation with pursed lip breathing ventilation device

    Device: Pursed lip breathing ventilation

  • Active comparator
    Control

    Non-invasive ventilation with standard non-invasive ventilation device

    Device: Standard non-invasive ventilation

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

05

What researchers measure

Primary outcomes

  1. Walking distance in 6-minutes walking test

    Time frame: 3 months

Secondary outcomes

  1. Mortality

    Time frame: 12 months

  2. Number of hospital admissions

    Time frame: 12 months

06

Study locations

5 sites
  • Thoraxklinik Heidelberg
    Heidelberg, Baden-Württemberg 69126, Germany
  • Waldburg-Zeil Kliniken - Fachkliniken Wangen
    Wangen, Baden-Württemberg 88239, Germany
  • Research Center Borstel
    Borstel, Schleswig-Holstein 23845, Germany
  • LungenClinic Großhansdorf
    Großhansdorf, Schleswig-Holstein 22937, Germany
  • Lungenklinik Hemer
    Hemer, 58675, Germany
07

Registry details

Key details

Study ID
NCT03299764
Lead sponsor
Research Center Borstel
Responsible party
Sponsor
First posted
Oct 3, 2017
Start date
Nov 1, 2017
Primary completion
Nov 1, 2026 (estimated)
Completion
Jul 1, 2027 (estimated)
Last update
Apr 12, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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