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.
This study is currently recruiting participants.
Verified September 2012 by FluidDA nv
Sponsor:
FluidDA nv
Information provided by (Responsible Party):
FluidDA nv
ClinicalTrials.gov Identifier:
NCT01684384
First received: September 6, 2012
Last updated: September 10, 2012
Last verified: September 2012
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Purpose
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 | Intervention |
|---|---|
|
Pulmonary Disease, Chronic Obstructive |
Radiation: Functional Respiratory Imaging |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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. |
Resource links provided by NLM:
Further study details as provided by FluidDA nv:
Primary Outcome Measures:
- Changes in functional respiratory imaging parameters [ Time Frame: Baseline (= during exacerbation) and after about 6 weeks (= after recovering) ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline (= during exacerbation) and after about 6 weeks (= after recovering) ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline (= during exacerbation) and after about 6 weeks (= after recovering) ] [ Designated as safety issue: No ]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:
- Reproducibility of segmentation [ Time Frame: Within 1 month of visit ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Radiation: Functional Respiratory Imaging
HRCT scan at FRC and TLC as taken during an episode of exacerbation and after recovering.
Other Name: HRCT scan
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01684384
Locations
| Belgium | |
| Antwerp University Hospital | Recruiting |
| Edegem, Antwerp, Belgium, 2650 | |
| Contact: Wilfried De Backer, MD, PhD wilfried.de.backer@uza.be | |
| Principal Investigator: Wilfried De Backer, MD, PhD | |
| Italy | |
| University of Florence | Not yet recruiting |
| Florence, Italy, 50134 | |
| Contact: Massimo Pistolesi, MD massimo.pistolesi@unifi.it | |
| Principal Investigator: Massimo Pistolesi, MD | |
| Netherlands | |
| University Medical Center Groningen | Not yet recruiting |
| Groningen, Netherlands, 9700RB | |
| Contact: Huib AM Kerstjens, MD h.a.m.kerstjens@umcg.nl | |
| Principal Investigator: Huib AM Kerstjens, MD | |
| Maastricht University Medical Center | Not yet recruiting |
| Maastricht, Netherlands, 6229HX | |
| Contact: Emiel FM Wouters, MD e.wouters@mumc.nl | |
| Principal Investigator: Emiel FM Wouters, MD | |
Sponsors and Collaborators
FluidDA nv
Investigators
| Principal Investigator: | Wilfried De Backer, MD, PhD | University Hospital, Antwerp |
| Principal Investigator: | Huib AM Kerstjens, MD | University Medical Centre Groningen |
| Principal Investigator: | Emiel FM Wouters, MD | Maastricht University Medical Center |
| Principal Investigator: | Massimo Pistolesi, MD | University of Florence |
More Information
No publications provided
| Responsible Party: | FluidDA nv |
| ClinicalTrials.gov Identifier: | NCT01684384 History of Changes |
| Other Study ID Numbers: | FLUI-2011-79 |
| Study First Received: | September 6, 2012 |
| Last Updated: | September 10, 2012 |
| Health Authority: | Belgium: Ethics Committee |
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:
|
Chronic Disease Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive |
Disease Attributes Pathologic Processes Respiratory Tract Diseases Lung Diseases, Obstructive |
ClinicalTrials.gov processed this record on May 19, 2013