Evidence-based Analysis of Low-dose CT in Management of COPD
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low-Dose Computed Tomography
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease, Diagnostic Imaging, Disease Management, Clinical Decision Support Systems, Cost-Utility Analysis
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MulticenterRecruitment
Arm Description
COPD phenotypization by Low-Dose Computed Tomography
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Inter-observer agreement (questionnaire)
To assess changes in inter-observer agreement between pulmonologist before and after assimilation of LDCT data.
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.
Full Information
NCT ID
NCT02599883
First Posted
November 4, 2015
Last Updated
November 5, 2015
Sponsor
Azienda Ospedaliero-Universitaria di Parma
1. Study Identification
Unique Protocol Identification Number
NCT02599883
Brief Title
Evidence-based Analysis of Low-dose CT in Management of COPD
Official Title
Impact of Low-dose Computed Tomography on the Management of Chronic Obstructive Pulmonary Disease Patients: an Evidence-based Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliero-Universitaria di Parma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic Obstructive Pulmonary Disease, Diagnostic Imaging, Disease Management, Clinical Decision Support Systems, Cost-Utility Analysis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
195 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MulticenterRecruitment
Arm Type
Experimental
Arm Description
COPD phenotypization by Low-Dose Computed Tomography
Intervention Type
Radiation
Intervention Name(s)
Low-Dose Computed Tomography
Intervention Description
Low-Dose Computed Tomography will be administered to COPD patients as part of COPD phenotypization.
Primary Outcome Measure Information:
Title
Impact of diagnostic imaging in assessing COPD by qualitative and quantitative evaluation (questionnaire)
Description
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.
Time Frame
Up to 3 years
Title
Clinical management of COPD in relation to therapy adjustment (questionnaire)
Description
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.
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Intra-observer agreement before and after disclosure of LDCT features (questionnaire)
Description
To assess the intra-observer agreement of pulmonologists before and after assimilation of LDCT data.
Time Frame
Up to 3 years
Title
Inter-observer agreement (questionnaire)
Description
To assess changes in inter-observer agreement between pulmonologist before and after assimilation of LDCT data.
Time Frame
Up to 3 years
Title
Additional costs derived from change in management of COPD after disclosure of LDCT features (comparison of costs)
Description
To evaluate additional costs for the regional health care system deemed by assimilation of LDCT data.
Time Frame
Up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicola Sverzellati, MD, PhD
Organizational Affiliation
Università di Parma
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Evidence-based Analysis of Low-dose CT in Management of COPD
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