Clinical trial NCT01684384: 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.
Official title: Correlation of Functional Respiratory Imaging Parameters With Lung Function Parameters and Patient Reported Outcome Measures During Exacerbation of COPD.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: 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
Lead sponsor: FLUIDDA nv
Sponsor class: INDUSTRY
First posted: 2012-09-13
Enrollment: 53
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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.

Primary outcomes:
measure: Changes in functional respiratory imaging parameters
timeFrame: Baseline (= during exacerbation) and after about 6 weeks (= after recovering)
measure: Changes in lung function parameters
timeFrame: Baseline (= during exacerbation) and after about 6 weeks (= after recovering)
Secondary outcomes:
measure: Changes in patient reported outcome (PRO) measures
timeFrame: Baseline (= during exacerbation) and after about 6 weeks (= after recovering)
Other outcomes:
measure: Reproducibility of segmentation
timeFrame: Within 1 month of visit
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
city: Florence
country: Italy
facility: University of Florence
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
Study officials:
affiliation: University Hospital, Antwerp
name: Wilfried De Backer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Groningen
name: Huib AM Kerstjens, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Medical Center
name: Emiel FM Wouters, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florence
name: Massimo Pistolesi, MD
role: PRINCIPAL_INVESTIGATOR
References: