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Completed

NCT Number: NCT00966459

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

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Computed Tomography

Procedure

1 low-dose CT is taken

Primary outcomes

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

  2. To obtain patient specific boundary conditions

Secondary outcomes

  1. To measure the resistance of the peripheral airways

  2. To measure the reaction of the airways on various inhalation medications

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 27, 2009
Registry last updated
Sep 1, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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