Long-term Effects of Non-invasive Ventilation in Hypercapnic Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT ID: NCT01592656
Last Updated: 2014-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
40 participants
INTERVENTIONAL
2011-02-28
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Non-invasive ventilation (NIV)
30 patients will receive NIV during 6 months = group 1
Functional Respiratory Imaging
CT-scan of thorax. At baseline, after 1 month and after 6 months.
Lung compliance measurement
At baseline
Non-invasive ventilation (Respironics)
Long-term non-invasive ventilation, starting at baseline until 6 months. At baseline the patients should have persisting hypercapnia (pCO2 \> 45 mmHg) under optimal conservative treatment other than NIV. The patients can be hospitalised or being treated at home at inclusion.
Control group
10 patients will act as control group, they will not be treated with NIV = group 2
Functional Respiratory Imaging
CT-scan of thorax. At baseline, after 1 month and after 6 months.
Lung compliance measurement
At baseline
Interventions
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Functional Respiratory Imaging
CT-scan of thorax. At baseline, after 1 month and after 6 months.
Lung compliance measurement
At baseline
Non-invasive ventilation (Respironics)
Long-term non-invasive ventilation, starting at baseline until 6 months. At baseline the patients should have persisting hypercapnia (pCO2 \> 45 mmHg) under optimal conservative treatment other than NIV. The patients can be hospitalised or being treated at home at inclusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Men and women
* Written informed consent obtained
* COPD patients GOLD II, III and IV
* Persisting hypercapnia (pCO2 \> 45 mmHg ) notwithstanding adequate treatment modalities (including oxygen) as proposed by the GOLD guidelines
* Stopped smoking
* Total lung capacity (TLC) \> 85%
Exclusion Criteria
* Asthma
* Restrictive lung disease
* Symptomatic or uncontrolled heart failure
* Current malignancy
* Suspected bad compliance for NIV treatment
* Pregnant women
* Not be able to speak the language of the participating center
* Received an investigational product within 4 weeks prior to inclusion in the study
40 Years
ALL
No
Sponsors
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FLUIDDA nv
INDUSTRY
Responsible Party
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Principal Investigators
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Wilfried De Backer, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Antwerp
Peter Wijkstra, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Groningen
Locations
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Antwerp University Hospital
Edegem, Antwerp, Belgium
University Medical Center Groningen
Groningen, , Netherlands
Countries
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Other Identifiers
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FLUI-2010-68
Identifier Type: -
Identifier Source: org_study_id
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