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

NCT ID: NCT00966459

Last Updated: 2009-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type OTHER

Computed Tomography

Intervention Type PROCEDURE

1 low-dose CT is taken

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Computed Tomography

1 low-dose CT is taken

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Antwerp

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University Hospital Antwerp, Department of Respiratory Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Antwerp

Edegem, Antwerp, Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PML_DOC_0803

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

COPD Originates in Polluted Air
NCT02236039 COMPLETED NA