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

NCT00966459 | Completed

• 1 other identifier: PML_DOC_0803
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (2)

• To obtain patient specific geometries of the central and peripheral small airways

• To obtain patient specific boundary conditions

Secondary Outcomes (2)

• To measure the resistance of the peripheral airways

• To measure the reaction of the airways on various inhalation medications

Study Arms (1)

1

OTHER

Procedure: Computed Tomography

Interventions

Computed Tomography PROCEDURE

1 low-dose CT is taken

1

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 26, 2009
• First Posted: August 27, 2009
• Study Start: November 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: May 1, 2009
• Last Updated: September 1, 2009

Record last verified: 2009-08

Locations

BE (1)