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
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05102305 -
A Multi-center,Prospective, OS to Evaluate the Effectiveness of 'NAC' Nebulizer Therapy in COPD (NEWEST)
|
||
| Completed |
NCT01867762 -
An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
|
Phase 2 | |
| Recruiting |
NCT05562037 -
Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA
|
N/A | |
| Terminated |
NCT04921332 -
Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD
|
N/A | |
| Completed |
NCT03089515 -
Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust
|
N/A | |
| Completed |
NCT02787863 -
Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology
|
Phase 4 | |
| Recruiting |
NCT05552833 -
Pulmonary Adaptive Responses to HIIT in COPD
|
N/A | |
| Recruiting |
NCT05835492 -
A Pragmatic Real-world Multicentre Observational Research Study to Explore the Clinical and Health Economic Impact of myCOPD
|
||
| Recruiting |
NCT05631132 -
May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases?
|
N/A | |
| Completed |
NCT03244137 -
Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
|
||
| Not yet recruiting |
NCT03282526 -
Volume Parameters vs Flow Parameters in Assessment of Reversibility in Chronic Obstructive Pulmonary Disease
|
N/A | |
| Completed |
NCT02546700 -
A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 2 | |
| Withdrawn |
NCT04446637 -
Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination vs Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol Free Combination in Patients With Stable COPD
|
Phase 3 | |
| Completed |
NCT04535986 -
A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD
|
Phase 3 | |
| Recruiting |
NCT05865184 -
Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
|
||
| Completed |
NCT03295474 -
Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.
|
||
| Completed |
NCT03256695 -
Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
| Withdrawn |
NCT04042168 -
Implications of Appropriate Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 4 | |
| Completed |
NCT03414541 -
Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease
|
Phase 2 | |
| Completed |
NCT02552160 -
DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy
|