Research to Evaluate a Possible Relation Between Values Obtained After Processing CT Images, Lung Function Tests and the Experience of the Patient During an Exacerbation in COPD Patients.

Study Overview
=================
Brief Summary
-----------------
In this study the consequences of exacerbations will be visualized by high resolution computed tomography (HRCT) scan at functional residual capacity (FRC) and total lung capacity (TLC) as taken during an episode of exacerbation and after recovering. Changes in HRCT based airway dimensions and computational fluid dynamic (CFD) -based resistance values will be correlated with changes in patient reported outcomes (PROs) and lung function tests recorded at the same time.

Official Title
-----------------
Correlation of Functional Respiratory Imaging Parameters With Lung Function Parameters and Patient Reported Outcome Measures During Exacerbation of COPD.

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

Intervention / Treatment
-----------------
* Radiation: Functional Respiratory Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, ≥ 40 years old COPD as defined by the global Initiative on obstructive lung disease4 Post-bronchodilator FEV1/FVC < 70% AND post-bronchodilator FEV1 <80%pred as documented in the last 5 years. Smoking history of at least 10 pack-years At entry in the study experiencing an exacerbation defined as an acute change in the patient 's baseline dyspnea, cough, and/or sputum that is beyond normal day to day variations, and that necessitates the administration or doubling of systemic corticosteroid treatment. Patients must be able to understand and complete protocol requirements, instructions, questionnaires and protocol-stated restrictions. Written and signed informed consent Exclusion Criteria: Pregnant or lactating females Patient diagnosed with asthma Patient with pneumonia as defined radiologically at the start of the exacerbation Patient with a history of or presence of lung cancer Patient with an indication for non-invasive ventilation Patient unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study. Patient who received any investigational new drug within the last 4 weeks prior to visit 1.

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: No treatment<br>CT-scans will be taken in the study. The EC of the University hospital antwerp considers this as an intervention. | Radiation: Functional Respiratory Imaging<br>* HRCT scan at FRC and TLC as taken during an episode of exacerbation and after recovering.<br>* Other names: HRCT scan;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in functional respiratory imaging parameters | The primary objective of this study is to evaluate whether changes in HRCT based airway dimensions and Computational Fluid Dynamic (CFD)-based resistance values correlate with changes in lung function parameters, under the conditions of exacerbation of COPD as well as after recovering from exacerbation. | Baseline (= during exacerbation) and after about 6 weeks (= after recovering) | 
| Changes in lung function parameters | The primary objective of this study is to evaluate whether changes in HRCT based airway dimensions and Computational Fluid Dynamic (CFD)-based resistance values correlate with changes in lung function parameters, under the conditions of exacerbation of COPD as well as after recovering from exacerbation. | Baseline (= during exacerbation) and after about 6 weeks (= after recovering) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in patient reported outcome (PRO) measures | The secondary objective is to check if the changes in CFD data actually correlate better with changes in PRO than changes in lung function parameters. | Baseline (= during exacerbation) and after about 6 weeks (= after recovering) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary Disease, Chronic Obstructive, COPD, Exacerbation, Functional Respiratory Imaging, High Resolution Computed Tomography, HRCT scan, Patient Reported Outcome, PRO, Computational Fluid Dynamic, CFD, Lung function parameters