Back to resultsResearch 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.
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Functional Respiratory Imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Pulmonary Disease, Chronic Obstructive focused on measuring 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
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.
Sites / Locations
- Antwerp University Hospital
- University of Florence
- University Medical Center Groningen
- Maastricht University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
No treatment
Arm Description
CT-scans will be taken in the study. The EC of the University hospital antwerp considers this as an intervention.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01684384
Brief Title
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.
Official Title
Correlation of Functional Respiratory Imaging Parameters With Lung Function Parameters and Patient Reported Outcome Measures During Exacerbation of COPD.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FLUIDDA nv
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No treatment
Arm Type
Experimental
Arm Description
CT-scans will be taken in the study. The EC of the University hospital antwerp considers this as an intervention.
Intervention Type
Radiation
Intervention Name(s)
Functional Respiratory Imaging
Other Intervention Name(s)
HRCT scan
Intervention Description
HRCT scan at FRC and TLC as taken during an episode of exacerbation and after recovering.
Primary Outcome Measure Information:
Title
Changes in functional respiratory imaging parameters
Description
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.
Time Frame
Baseline (= during exacerbation) and after about 6 weeks (= after recovering)
Title
Changes in lung function parameters
Description
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.
Time Frame
Baseline (= during exacerbation) and after about 6 weeks (= after recovering)
Secondary Outcome Measure Information:
Title
Changes in patient reported outcome (PRO) measures
Description
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.
Time Frame
Baseline (= during exacerbation) and after about 6 weeks (= after recovering)
Other Pre-specified Outcome Measures:
Title
Reproducibility of segmentation
Description
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.
Time Frame
Within 1 month of visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilfried De Backer, MD, PhD
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Huib AM Kerstjens, MD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emiel FM Wouters, MD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Massimo Pistolesi, MD
Organizational Affiliation
University of Florence
Official's Role
Principal Investigator
Facility Information:
Facility Name
Antwerp University Hospital
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Facility Name
University of Florence
City
Florence
ZIP/Postal Code
50134
Country
Italy
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9700RB
Country
Netherlands
Facility Name
Maastricht University Medical Center
City
Maastricht
ZIP/Postal Code
6229HX
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
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.
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