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.

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01684384
• Other study ID #: FLUI-2011-79
• Status: Completed
• Phase: N/A
• First received: September 6, 2012
• Last updated: November 26, 2014
• Start date: September 2012
• Est. completion date: September 2014

Study information

• Verified date: November 2014
• Source: FLUIDDA nv
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Radiation:
• Functional Respiratory Imaging
HRCT scan at FRC and TLC as taken during an episode of exacerbation and after recovering.

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Edegem	Antwerp
Italy	University of Florence	Florence
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Maastricht University Medical Center	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
FLUIDDA nv

Countries where clinical trial is conducted

Belgium,  Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reproducibility of segmentation	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.	Within 1 month of visit	No
Primary	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)	No
Primary	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)	No
Secondary	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)	No