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.

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Radiation: Functional Respiratory Imaging

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • Antwerp University Hospital
• Italy
  • Florence, Italy, 50134
    • University of Florence
• Netherlands
  • Groningen, Netherlands, 9700RB
    • University Medical Center Groningen
  • Maastricht, Netherlands, 6229HX
    • Maastricht University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: FLUIDDA nv
• Investigators: Principal Investigator: Huib AM Kerstjens, MD, University Medical Center Groningen; Principal Investigator: Emiel FM Wouters, MD, Maastricht University Medical Center; Principal Investigator: Massimo Pistolesi, MD, University of Florence

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: September 6, 2012
• First Submitted That Met QC Criteria: September 10, 2012
• First Posted (Estimate): September 13, 2012

Study Record Updates

• Last Update Posted (Estimate): December 2, 2014
• Last Update Submitted That Met QC Criteria: November 26, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: COPD; Exacerbation; PRO; Pulmonary Disease, Chronic Obstructive; Patient Reported Outcome; Functional Respiratory Imaging; Computational Fluid Dynamic; CFD; High Resolution Computed Tomography; HRCT scan; Lung function parameters
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Chronic Disease
• Other Study ID Numbers: FLUI-2011-79