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

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ClinicalTrials.gov Identifier: NCT00966459
Recruitment Status : Completed
First Posted : August 27, 2009
Last Update Posted : September 1, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Procedure: Computed Tomography

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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
Study Start Date : November 2008
Primary Completion Date : April 2009
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD CT Scans
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
1 Procedure: Computed Tomography
1 low-dose CT is taken


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: August 27, 2009    Key Record Dates
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