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.

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01684384

Enrollment

Registered

2012-09-13

Start date

2012-09-30

Completion date

2014-09-30

Last updated

2014-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

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

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.

Interventions

RADIATIONFunctional Respiratory Imaging

HRCT scan at FRC and TLC as taken during an episode of exacerbation and after recovering.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Changes in functional respiratory imaging parameters	Baseline (= during exacerbation) and after about 6 weeks (= after recovering)	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.
Changes in lung function parameters	Baseline (= during exacerbation) and after about 6 weeks (= after recovering)	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.

Secondary

Measure	Time frame	Description
Changes in patient reported outcome (PRO) measures	Baseline (= during exacerbation) and after about 6 weeks (= after recovering)	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.

Other

Measure	Time frame	Description
Reproducibility of segmentation	Within 1 month of visit	As tertiary objective the reproducibility of the segmentations done by the centers will be evaluated. To accomplish reproducible segmentations the multiple centers will be guided to perform accurate segmentations, and bottlenecks in the usage of the program will be identified and resolved in order to simplify it where necessary and possible.

Countries

Belgium, Italy, Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026