Chronic Obstructive Pulmonary DiseaseNCT02599883
Evidence-based Analysis of Low-dose CT in Management of COPD
A study testing Low-Dose Computed Tomography in people with Chronic Obstructive Pulmonary Disease, run by Azienda Ospedaliero-Universitaria di Parma.
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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Low-Dose Computed Tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
Read more
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).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Low-Dose Computed Tomography
- Keywords
- Chronic Obstructive Pulmonary Disease, Diagnostic Imaging, Disease Management, Clinical Decision Support Systems, Cost-Utility Analysis
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Dose Computed TomographyRadiation
Low-Dose Computed Tomography will be administered to COPD patients as part of COPD phenotypization.
| Study group | Role | What they receive |
|---|---|---|
| MulticenterRecruitment | Experimental | COPD phenotypization by Low-Dose Computed Tomography Receives: Radiation: Low-Dose Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 years
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.
Measured: Up to 3 years
Secondary outcomes (3)
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.
Measured: Up to 3 years
Inter-observer agreement (questionnaire)
To assess changes in inter-observer agreement between pulmonologist before and after assimilation of LDCT data.
Measured: Up to 3 years
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.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study startSep 2012
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Parma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Sverzellati, Azienda Ospedaliero-Universitaria di Parma
- Investigators
- Nicola Sverzellati, MD, PhD, Principal investigator, Università di Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02599883
- Sponsor's protocol ID
- ImagingCOPD_Multicenter
- Status last verified
- Nov 2015
- First submitted
- 4 Nov 2015
- Last updated
- 9 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Low-dose Computed Tomography on the Management of Chronic Obstructive Pulmonary Disease Patients: an Evidence-based Study
- ClinicalTrials.gov ID
- NCT02599883
- Acronym / sponsor ID
- ImagingCOPD_Multicenter
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, Diagnostic Imaging, Disease Management, Clinical Decision Support Systems, Cost-Utility Analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ParmaUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 9 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MulticenterRecruitment | Experimental | Radiation: Low-Dose Computed TomographyCOPD phenotypization by Low-Dose Computed Tomography |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Dose Computed TomographyLow-Dose Computed Tomography will be administered to COPD patients as part of COPD phenotypization. | Radiation | MulticenterRecruitment |
Primary outcome
Impact of diagnostic imaging in assessing COPD by qualitative and quantitative evaluation (questionnaire)
Time frame: Up to 3 years
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)
Time frame: Up to 3 years
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.
3 secondary outcomes
Intra-observer agreement before and after disclosure of LDCT features (questionnaire)
Time frame: Up to 3 years
Inter-observer agreement (questionnaire)
Time frame: Up to 3 years
Additional costs derived from change in management of COPD after disclosure of LDCT features (comparison of costs)
Time frame: Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicola Sverzellati, MD, PhD principal investigator
Università di Parma
Questions about this trial
What is this clinical trial studying?
A study testing Low-Dose Computed Tomography in people with Chronic Obstructive Pulmonary Disease, run by Azienda Ospedaliero-Universitaria di Parma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of diagnostic imaging in assessing COPD by qualitative and quantitative evaluation (questionnaire) (time frame: Up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2015.