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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00966459
• Other study ID #: PML_DOC_0803
• Status: Completed
• Phase: N/A
• First received: August 26, 2009
• Last updated: August 31, 2009
• Start date: November 2008
• Est. completion date: May 2009

Study information

• Verified date: August 2009
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Procedure:
• Computed Tomography
1 low-dose CT is taken

Locations

Country	Name	City	State
Belgium	University Hospital Antwerp	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To obtain patient specific geometries of the central and peripheral small airways			No
Primary	To obtain patient specific boundary conditions			No
Secondary	To measure the resistance of the peripheral airways			No
Secondary	To measure the reaction of the airways on various inhalation medications			No