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Computed Tomography (CT) and Lung Function Data Collection for Computational Fluid Dynamics (CFD) in Chronic Obstructive Pulmonary Disease (COPD) Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00966459
First Posted: August 27, 2009
Last Update Posted: September 1, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Antwerp
  Purpose

In this study, 20 COPD patients will undergo a high-resolution/multi slice CT scan and lung function tests to obtain patient specific geometries of the central and peripheral small airways and patient specific boundary conditions.

With Computational Fluid Dynamics (CFD), the investigators will be able to reconstruct the geometry and measure the resistance of the peripheral airways.

In a later stage, CFD will be used to simulate the reaction of the airways on various inhalation medications.


Condition Intervention
Chronic Obstructive Pulmonary Disease Procedure: Computed Tomography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Computed Tomography (CT) and Lung Function Data Collection for Computational Fluid Dynamics (CFD) in COPD Patients

Resource links provided by NLM:


Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • To obtain patient specific geometries of the central and peripheral small airways
  • To obtain patient specific boundary conditions

Secondary Outcome Measures:
  • To measure the resistance of the peripheral airways
  • To measure the reaction of the airways on various inhalation medications

Enrollment: 20
Study Start Date: November 2008
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Procedure: Computed Tomography
1 low-dose CT is taken

  Eligibility

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with documented COPD based on the following criteria:

    • Smoking history of at least 10 pack-years.
    • Decreased Tiffeneau index (FEV1/(F)VC < 0.70).
  2. Patients aged ≥ 40 years.
  3. Patients should present moderate to very severe COPD with an FEV1 < 80% of predicted (GOLD 2, 3 and 4).
  4. Patients should be treated according to GOLD guidelines.
  5. Maintained on stable respiratory medications for 4 weeks prior to visit 1
  6. Able to perform lung function tests.

Exclusion Criteria:

  1. Patients below the age of 40.
  2. Patients who are pregnant or are breast-feeding.
  3. A respiratory infection or exacerbation of COPD in the four weeks prior to screening.
  4. BMI > 35 kg/m².
  5. Patients treated with BiPAP or CPAP.
  6. Known active tuberculosis.
  7. A history of asthma, cystic fibrosis, central bronchiectasis, interstitial lung disease or pulmonary thromboembolic disease.
  8. A history of thoracotomy with pulmonary resection.
  9. Active or untreated malignancy.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00966459


Locations
Belgium
University Hospital Antwerp
Edegem, Antwerp, Belgium, 2650
Sponsors and Collaborators
University Hospital, Antwerp
  More Information

Responsible Party: Prof Dr Wilfried De Backer, University Hospital Antwerp, Department of Respiratory Medicine
ClinicalTrials.gov Identifier: NCT00966459     History of Changes
Other Study ID Numbers: PML_DOC_0803
First Submitted: August 26, 2009
First Posted: August 27, 2009
Last Update Posted: September 1, 2009
Last Verified: August 2009

Keywords provided by University Hospital, Antwerp:
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases