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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Computed Tomography
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital Antwerp

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

Outcomes

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

Full Information

First Posted
August 26, 2009
Last Updated
August 31, 2009
Sponsor
University Hospital, Antwerp
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1. Study Identification

Unique Protocol Identification Number
NCT00966459
Brief Title
Computed Tomography (CT) and Lung Function Data Collection for Computational Fluid Dynamics (CFD) in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official Title
Computed Tomography (CT) and Lung Function Data Collection for Computational Fluid Dynamics (CFD) in COPD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Antwerp

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Intervention Description
1 low-dose CT is taken
Primary Outcome Measure Information:
Title
To obtain patient specific geometries of the central and peripheral small airways
Title
To obtain patient specific boundary conditions
Secondary Outcome Measure Information:
Title
To measure the resistance of the peripheral airways
Title
To measure the reaction of the airways on various inhalation medications

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Patients aged ≥ 40 years. Patients should present moderate to very severe COPD with an FEV1 < 80% of predicted (GOLD 2, 3 and 4). Patients should be treated according to GOLD guidelines. Maintained on stable respiratory medications for 4 weeks prior to visit 1 Able to perform lung function tests. Exclusion Criteria: Patients below the age of 40. Patients who are pregnant or are breast-feeding. A respiratory infection or exacerbation of COPD in the four weeks prior to screening. BMI > 35 kg/m². Patients treated with BiPAP or CPAP. Known active tuberculosis. A history of asthma, cystic fibrosis, central bronchiectasis, interstitial lung disease or pulmonary thromboembolic disease. A history of thoracotomy with pulmonary resection. Active or untreated malignancy.
Facility Information:
Facility Name
University Hospital Antwerp
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium

12. IPD Sharing Statement

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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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