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.
NCT ID: NCT01684384
Last Updated: 2014-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
53 participants
INTERVENTIONAL
2012-09-30
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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No treatment
CT-scans will be taken in the study. The EC of the University hospital antwerp considers this as an intervention.
Functional Respiratory Imaging
HRCT scan at FRC and TLC as taken during an episode of exacerbation and after recovering.
Interventions
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Functional Respiratory Imaging
HRCT scan at FRC and TLC as taken during an episode of exacerbation and after recovering.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
ALL
No
Sponsors
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FLUIDDA nv
INDUSTRY
Responsible Party
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Principal Investigators
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Wilfried De Backer, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Antwerp
Huib AM Kerstjens, MD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Groningen
Emiel FM Wouters, MD
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Center
Massimo Pistolesi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florence
Locations
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Antwerp University Hospital
Edegem, Antwerp, Belgium
University of Florence
Florence, , Italy
University Medical Center Groningen
Groningen, , Netherlands
Maastricht University Medical Center
Maastricht, , Netherlands
Countries
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Other Identifiers
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FLUI-2011-79
Identifier Type: -
Identifier Source: org_study_id