Evidence-based Analysis of Low-dose CT in Management of COPD

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02599883
• Other study ID #: ImagingCOPD_Multicenter
• Status: Completed
• Phase: N/A
• First received: November 4, 2015
• Last updated: November 5, 2015
• Start date: September 2012
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Azienda Ospedaliero-Universitaria di Parma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 90 Years

Eligibility

Inclusion Criteria:

• COPD diagnosis according to ATS/ERS criteria (post-bronchodilator FEV1 to FVC ratio < 0.7);

• clinical stability, namely no acute exacerbation in the previous 4 weeks;

• clinical indication for low-dose computed tomography (LDCT) to investigate bronchiectasis, interstitial lung disease, or pulmonary hypertension.

Exclusion Criteria:

• pregnancy;

• patients with congenital or acquired immune deficit;

• patients with lung transplantation;

• patients under oxygen therapy;

• patients with diagnosis of asthma or other clinically relevant pulmonary disease other than COPD.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Radiation:
• Low-Dose Computed Tomography
Low-Dose Computed Tomography will be administered to COPD patients as part of COPD phenotypization.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria di Parma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of diagnostic imaging in assessing COPD by qualitative and quantitative evaluation (questionnaire)	To quantify the refinement of the diagnosis of COPD patients when LDCT data are added to standard evaluation, namely, conventional clinical-functional assessment and chest radiography.	Up to 3 years	No
Primary	Clinical management of COPD in relation to therapy adjustment (questionnaire)	To describe the change in management of COPD patients when LDCT data are added to standard evaluation, namely, conventional clinical-functional assessment and chest radiography.	Up to 3 years	No
Secondary	Intra-observer agreement before and after disclosure of LDCT features (questionnaire)	To assess the intra-observer agreement of pulmonologists before and after assimilation of LDCT data.	Up to 3 years	No
Secondary	Inter-observer agreement (questionnaire)	To assess changes in inter-observer agreement between pulmonologist before and after assimilation of LDCT data.	Up to 3 years	No
Secondary	Additional costs derived from change in management of COPD after disclosure of LDCT features (comparison of costs)	To evaluate additional costs for the regional health care system deemed by assimilation of LDCT data.	Up to 3 years	No