Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Impact of Low-dose Computed Tomography on the Management of Chronic Obstructive Pulmonary Disease Patients: an Evidence-based Study
Background: Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of
chronic morbidity and mortality worldwide. There is debate about diagnosis and management of
COPD because it was described as complex syndrome accounting for various pulmonary and
extrapulmonary abnormalities. As a result, there is consensus that both clinical evaluation
and pulmonary function tests (PFTs) data by themselves do not adequately describe the
complexity of the disease. The chest radiograph is the sole imaging examination recommended
for the routine evaluation of these patients by the physicians guidelines (GOLD
guidelines),which, however, are also debating on the utility of computed tomography (CT) in
this setting. Indeed, a number of studies reported a dramatic increasing use of CT of the
chest for COPD assessment, in both clinical and research settings. COPD assessment by CT
seems to improve the accuracy and completeness of the clinical evaluation of these patients.
Nevertheless, the clinical utility of CT has yet to be proved by prospective studies or
defined by guidelines.
Objectives: To evaluate the change in the diagnosis and management of COPD when multiple
CT-derived information is added to pre-test evaluation.
Methods: Four pulmonologists with various expertise in the field will review clinical data,
PFTs results, and chest radiographs of 200 consecutive COPD patients diagnosed according to
current guidelines. Therefore, after two months from the first evaluation, the
pulmonologists will review the clinical and PFTs records with comprehensive information
about low-dose CT (LDCT) previously performed in a week from the chest radiograph.
Information about LDCT findings will include qualitative assessment by an experienced chest
radiologist and quantitative analysis by means of an innovative 3D imaging dedicated
software. Phenotype assessment and patient care decisions (e.g. therapeutic and follow-up
strategies, need of additional tests etc.) will be recorded before and after assimilation of
LDCT data.
Expected results: This evidence-based prospective study will test the impact of chest LDCT
on management of COPD patient. In addition, the level of agreement between pulmonologists in
terms of diagnosis and therapeutic strategies will be assessed. Furthermore, the study will
evaluate the need for additional tests referable to LDCT information and their impact on the
health care system (e.g. in terms of additional costs).
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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