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

U.S. FDA Resources

Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00966459

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

No publications provided

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
Study First Received: August 26, 2009
Last Updated: August 31, 2009
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by University Hospital, Antwerp:
COPD

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

ClinicalTrials.gov processed this record on May 19, 2013