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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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ClinicalTrials.gov Identifier: NCT01684384
Recruitment Status : Completed
First Posted : September 13, 2012
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
FLUIDDA nv

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.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Radiation: Functional Respiratory Imaging Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Correlation of Functional Respiratory Imaging Parameters With Lung Function Parameters and Patient Reported Outcome Measures During Exacerbation of COPD.
Study Start Date : September 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

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U.S. FDA Resources

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 Name: HRCT scan



Primary Outcome Measures :
  1. Changes in functional respiratory imaging parameters [ Time Frame: 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.

  2. Changes in lung function parameters [ Time Frame: 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 Outcome Measures :
  1. Changes in patient reported outcome (PRO) measures [ Time Frame: 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 Outcome Measures:
  1. Reproducibility of segmentation [ Time Frame: 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.



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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01684384


Locations
Belgium
Antwerp University Hospital
Edegem, Antwerp, Belgium, 2650
Italy
University of Florence
Florence, Italy, 50134
Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700RB
Maastricht University Medical Center
Maastricht, Netherlands, 6229HX
Sponsors and Collaborators
FLUIDDA nv
Investigators
Principal Investigator: Wilfried De Backer, MD, PhD University Hospital, Antwerp
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

Responsible Party: FLUIDDA nv
ClinicalTrials.gov Identifier: NCT01684384     History of Changes
Other Study ID Numbers: FLUI-2011-79
First Posted: September 13, 2012    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: November 2014

Keywords provided by FLUIDDA nv:
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

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive