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.

NCT01684384 | Completed

• 1 other identifier: FLUI-2011-79
• Study Type: interventional
• Target: 53
• Locations: 3 countries
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (2)

• Changes in functional respiratory imaging parameters

  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.

  Baseline (= during exacerbation) and after about 6 weeks (= after recovering)

• Changes in lung function parameters

  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.

  Baseline (= during exacerbation) and after about 6 weeks (= after recovering)

Secondary Outcomes (1)

• Changes in patient reported outcome (PRO) measures

  Baseline (= during exacerbation) and after about 6 weeks (= after recovering)

Other Outcomes (1)

• Reproducibility of segmentation

  Within 1 month of visit

Study Arms (1)

No treatment

EXPERIMENTAL

CT-scans will be taken in the study. The EC of the University hospital antwerp considers this as an intervention.

Radiation: Functional Respiratory Imaging

Interventions

Functional Respiratory Imaging RADIATION

HRCT scan at FRC and TLC as taken during an episode of exacerbation and after recovering.

Also known as: HRCT scan

No treatment

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• FLUIDDA nv: lead

Study Sites (4)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Location

University of Florence

Florence, 50134, Italy

Location

University Medical Center Groningen

Groningen, 9700RB, Netherlands

Location

Maastricht University Medical Center

Maastricht, 6229HX, Netherlands

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wilfried De Backer, MD, PhD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

• Huib AM Kerstjens, MD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

• Emiel FM Wouters, MD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

• Massimo Pistolesi, MD

  University of Florence

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2012
• First Posted: September 13, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: December 2, 2014

Record last verified: 2014-11

Locations

IT (1); BE (1); NL (2)