Clinical trial NCT01592656: Long-term Effects of Non-invasive Ventilation in Hypercapnic Chronic Obstructive Pulmonary Disease (COPD) Patients
Official title: Long-term Effects of Non-invasive Ventilation in Hypercapnic COPD Patients.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease
GOLD stages II, III and IV
Computed Tomography scan
Functional Respiratory Imaging
Non-Invasive Ventilation
Arterial Blood Gas
Hypercapnic
Health Related Quality of Life
Lung compliance
Lead sponsor: FLUIDDA nv
Sponsor class: INDUSTRY
First posted: 2012-05-07
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this multicenter study the comparison of the mass flow distribution and redistribution versus the relative blood flow per lobe (as a surrogate for Ventilation/ Perfusion (V/Q) matching) with functional respiratory imaging (FRI) and arterial blood gas (ABG) values will be evaluated in hypercapnic Chronic Obstructive Pulmonary Disease (COPD) patients. Therefore a low dose Computed Tomography (CT) scan will be taken in a population of 30 patients with non-invasive ventilation (NIV) and in a control group of 10 patients without NIV. The CT-scan will be used for FRI.


Eligibility criteria: Inclusion Criteria:

* Age: ≥ 40 years old
* 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:

* Treatment with home NIV or Continuous Positive Airway Pressure (CPAP)
* 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

Primary outcomes:
measure: Changes in the distribution of the mass flow per lobe and the relative proportion of bloodvessels, as obtained from functional respiratory imaging (FRI) and arterial blood gas (ABG).
timeFrame: At baseline, after 1 month and after 6 months of treatment with non-invasive ventilation (NIV)
Secondary outcomes:
measure: Health related quality of life
timeFrame: At baseline, after 1 month and after 6 months
measure: Lung function tests
timeFrame: At baseline, after 1 month and after 6 months
measure: Hospital admissions
timeFrame: After 1 month and after 6 months
measure: Exercise tolerance
timeFrame: At baseline, after 1 month and after 6 months
measure: Local airway volume and resistance
timeFrame: At baseline, after 1 month and after 6 months
measure: Prediction of breathing pattern
timeFrame: At baseline
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Hospital, Antwerp
name: Wilfried De Backer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Groningen
name: Peter Wijkstra, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: