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. (see Contacts and Locations)
Verified September 2012 by FluidDA nv
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 09, 2014