Long-term Effects of Non-invasive Ventilation in Hypercapnic Chronic Obstructive Pulmonary Disease (COPD) Patients

FLUIDDA

Status and phase: Terminated; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Radiation: Functional Respiratory Imaging; Other: Lung compliance measurement; Device: Non-invasive ventilation (Respironics)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01592656

FLUI-2010-68

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups, including a placebo group

Non-invasive ventilation (NIV)

Active Comparator group

Description:

30 patients will receive NIV during 6 months = group 1

Treatment:

Radiation: Functional Respiratory Imaging

Device: Non-invasive ventilation (Respironics)

Other: Lung compliance measurement

Control group

Placebo Comparator group

Description:

10 patients will act as control group, they will not be treated with NIV = group 2

Treatment:

Radiation: Functional Respiratory Imaging

Other: Lung compliance measurement