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:
Information provided by:
University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT00966459
First received: August 26, 2009
Last updated: August 31, 2009
Last verified: August 2009

August 26, 2009
August 31, 2009
November 2008
April 2009   (final data collection date for primary outcome measure)
  • To obtain patient specific geometries of the central and peripheral small airways [ Designated as safety issue: No ]
  • To obtain patient specific boundary conditions [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00966459 on ClinicalTrials.gov Archive Site
  • To measure the resistance of the peripheral airways [ Designated as safety issue: No ]
  • To measure the reaction of the airways on various inhalation medications [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Computed Tomography (CT) and Lung Function Data Collection for Computational Fluid Dynamics (CFD) in Chronic Obstructive Pulmonary Disease (COPD) Patients
Computed Tomography (CT) and Lung Function Data Collection for Computational Fluid Dynamics (CFD) in COPD Patients

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Chronic Obstructive Pulmonary Disease
Procedure: Computed Tomography
1 low-dose CT is taken
1
Intervention: Procedure: Computed Tomography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
May 2009
April 2009   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00966459
PML_DOC_0803
No
Prof Dr Wilfried De Backer, University Hospital Antwerp, Department of Respiratory Medicine
University Hospital, Antwerp
Not Provided
Not Provided
University Hospital, Antwerp
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP