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

Phase 2TerminatedNCT01592656

FLUIDDA nv40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Non-invasive ventilation (Respironics)DEVICE

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.

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (2)

Antwerp University Hospital

Edegem, Antwerp, Belgium

University Medical Center Groningen

Groningen, Netherlands

Outcomes

Primary Outcomes

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).

The primary objective of this study is the comparison of the mass flow distribution and redistribution versus the relative blood flow per lobe (as a surrogate for V/Q matching) with FRI and ABG values in hypercapnic COPD patients treated with long-term NIV.

Time frame: At baseline, after 1 month and after 6 months of treatment with non-invasive ventilation (NIV)

Secondary Outcomes

Health related quality of life

Saint George's Respiratory Questionnaire (SGRQ) and Severe Respiratory Insufficiency (SRI) Questionnaire

Time frame: At baseline, after 1 month and after 6 months

Lung function tests

Spirometry, reversibility, plethysmography, diffusion, Maximal Inspiratory Pressure (MIP), Maximal Expiratory Pressure (MEP)

Time frame: At baseline, after 1 month and after 6 months

Hospital admissions

Length and frequency of admission, severity of exacerbations, ICU admissions

Time frame: After 1 month and after 6 months

Exercise tolerance

6 minutes walking test and oximetry measurement

Time frame: At baseline, after 1 month and after 6 months

Local airway volume and resistance

CT-scan of thorax. CT scan is performed with a low radiation protocol. These images are made to perform computational fluid dynamics on in order to obtain more information on regional lung function characteristics.

Time frame: At baseline, after 1 month and after 6 months

Prediction of breathing pattern

The tertiary objective of the study is to predict the breathing pattern (including tidal volume) during NIV when using the data of patient specific lobar compliance and regional resistance at baseline.

Time frame: At baseline