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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Procedure: Computed Tomography

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • University Hospital Antwerp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1	Procedure: Computed Tomography; 1 low-dose CT is taken

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To obtain patient specific geometries of the central and peripheral small airways
To obtain patient specific boundary conditions

Secondary Outcome Measures

Outcome Measure
To measure the resistance of the peripheral airways
To measure the reaction of the airways on various inhalation medications

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: August 26, 2009
• First Submitted That Met QC Criteria: August 26, 2009
• First Posted (Estimate): August 27, 2009

Study Record Updates

• Last Update Posted (Estimate): September 1, 2009
• Last Update Submitted That Met QC Criteria: August 31, 2009
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Keywords: COPD
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: PML_DOC_0803