Study Stopped
Devices not available at the moment.
Evaluation of Non-invasive Pursed-lip Breathing Ventilation (PLBV) in Advanced COPD
1 other identifier
interventional
270
1 country
5
Brief Summary
Comparison of a conventional non-invasive ventilation to a non-invasive pursed-lip breathing ventilation (PLBV) ventilation in advanced COPD
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2017
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2017
CompletedFirst Posted
Study publicly available on registry
October 3, 2017
CompletedStudy Start
First participant enrolled
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
April 12, 2024
April 1, 2024
9 years
September 27, 2017
April 10, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Walking distance in 6-minutes walking test
3 months
Secondary Outcomes (2)
Mortality
12 months
Number of hospital admissions
12 months
Study Arms (2)
Intervention
EXPERIMENTALNon-invasive ventilation with pursed lip breathing ventilation device
Control
ACTIVE COMPARATORNon-invasive ventilation with standard non-invasive ventilation device
Interventions
A non-invasive ventilation device mimicking the pursed lip breathing in COPD patients will be used.
Eligibility Criteria
You may qualify if:
- Signed informed consent
- Age \>40 years
- COPD diagnosis known for at least 12 months
- NIV therapy for at least 3 months
- \. 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
You may not qualify if:
- 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
- MWT 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Thoraxklinik Heidelberg
Heidelberg, Baden-Wurttemberg, 69126, Germany
Waldburg-Zeil Kliniken - Fachkliniken Wangen
Wangen, Baden-Wurttemberg, 88239, Germany
Research Center Borstel
Borstel, Schleswig-Holstein, 23845, Germany
LungenClinic Großhansdorf
Großhansdorf, Schleswig-Holstein, 22937, Germany
Lungenklinik Hemer
Hemer, 58675, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2017
First Posted
October 3, 2017
Study Start
November 1, 2017
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
July 1, 2027
Last Updated
April 12, 2024
Record last verified: 2024-04