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

Study Overview
=================
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.

Official Title
-----------------
Long-term Effects of Non-invasive Ventilation in Hypercapnic COPD Patients.

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Radiation: Functional Respiratory Imaging
* Other: Lung compliance measurement
* Device: Non-invasive ventilation (Respironics)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Non-invasive ventilation (NIV)<br>30 patients will receive NIV during 6 months = group 1 | Radiation: Functional Respiratory Imaging<br>* CT-scan of thorax. At baseline, after 1 month and after 6 months.<br>Other: Lung compliance measurement<br>* At baseline<br>Device: Non-invasive ventilation (Respironics)<br>* 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.<br>* Other names: Trilogy device (Respironics);|
| Placebo Comparator: Control group<br>10 patients will act as control group, they will not be treated with NIV = group 2 | Radiation: Functional Respiratory Imaging<br>* CT-scan of thorax. At baseline, after 1 month and after 6 months.<br>Other: Lung compliance measurement<br>* At baseline<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At baseline, after 1 month and after 6 months of treatment with non-invasive ventilation (NIV) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life | Saint George's Respiratory Questionnaire (SGRQ) and Severe Respiratory Insufficiency (SRI) Questionnaire | At baseline, after 1 month and after 6 months | 
| Lung function tests | Spirometry, reversibility, plethysmography, diffusion, Maximal Inspiratory Pressure (MIP), Maximal Expiratory Pressure (MEP) | At baseline, after 1 month and after 6 months | 
| Hospital admissions | Length and frequency of admission, severity of exacerbations, ICU admissions | After 1 month and after 6 months | 
| Exercise tolerance | 6 minutes walking test and oximetry measurement | 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. | 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. | At baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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