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

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Procedure: Computed Tomography

• Registration Number: NCT00966459
• Lead Sponsor: University Hospital, Antwerp

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2009-04
• Study Completion: 2009-05
• Status Verified: 2009-08
• Study First Submitted: 2009-08-26
• Study First Submitted QC: 2009-08-26
• Study First Posted: 2009-08-27
• Last Update Submitted: 2009-08-31
• Last Update Posted: 2009-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Computed Tomography	-

Primary Outcome Measures

Name	Time	Method
To obtain patient specific geometries of the central and peripheral small airways
To obtain patient specific boundary conditions

Secondary Outcome Measures

Name	Time	Method
To measure the resistance of the peripheral airways
To measure the reaction of the airways on various inhalation medications

Trial Locations

Locations (1)

University Hospital Antwerp; 🇧🇪 Edegem, Antwerp, Belgium