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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Radiation: Functional Respiratory Imaging
- Registration Number
- NCT01684384
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description No treatment Functional Respiratory Imaging CT-scans will be taken in the study. The EC of the University hospital antwerp considers this as an intervention.
- Primary Outcome Measures
Name Time Method Changes in lung function parameters 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.
Changes in functional respiratory imaging parameters 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
Name Time Method Changes in patient reported outcome (PRO) measures 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.
Trial Locations
- Locations (4)
Antwerp University Hospital
🇧🇪Edegem, Antwerp, Belgium
University of Florence
🇮🇹Florence, Italy
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Maastricht University Medical Center
🇳🇱Maastricht, Netherlands