Research to Evaluate a Possible Relation Between Values Obtained After Processing CT Images, Lung Function Tests and the Experience of the Patient During an Exacerbation in COPD Patients.

FLUIDDA

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Radiation: Functional Respiratory Imaging

Study type: Interventional

Funder types: Industry

Identifiers

NCT01684384

FLUI-2011-79

Details and patient eligibility

About

In this study the consequences of exacerbations will be visualized by high resolution computed tomography (HRCT) scan at functional residual capacity (FRC) and total lung capacity (TLC) as taken during an episode of exacerbation and after recovering. Changes in HRCT based airway dimensions and computational fluid dynamic (CFD) -based resistance values will be correlated with changes in patient reported outcomes (PROs) and lung function tests recorded at the same time.

Enrollment: 53 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, ≥ 40 years old
• COPD as defined by the global Initiative on obstructive lung disease4
• Post-bronchodilator FEV1/FVC < 70% AND post-bronchodilator FEV1 <80%pred as documented in the last 5 years.
• Smoking history of at least 10 pack-years
• At entry in the study experiencing an exacerbation defined as an acute change in the patient 's baseline dyspnea, cough, and/or sputum that is beyond normal day to day variations, and that necessitates the administration or doubling of systemic corticosteroid treatment.
• Patients must be able to understand and complete protocol requirements, instructions, questionnaires and protocol-stated restrictions.
• Written and signed informed consent

Exclusion criteria

• Pregnant or lactating females
• Patient diagnosed with asthma
• Patient with pneumonia as defined radiologically at the start of the exacerbation
• Patient with a history of or presence of lung cancer
• Patient with an indication for non-invasive ventilation
• Patient unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
• Patient who received any investigational new drug within the last 4 weeks prior to visit 1.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

53 participants in 1 patient group

No treatment

Experimental group

Description:

CT-scans will be taken in the study. The EC of the University hospital antwerp considers this as an intervention.

Treatment:

Radiation: Functional Respiratory Imaging