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This is a multicenter observational prospective study in smokers or ex-smokers with cumulative exposure ≥ 10 a / p (years / pack) with respiratory symptoms and presenting a normal spirometry.
The patients who sign the corresponding informed consent, will undergo a DLCO and will be divided into two groups according to the result:
Both groups will be followed for 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I. Patients with DLCO <80%. | Patients with DLCO <80% will be followed at baseline and once a year during the study |
| |
| Group II. Patients with DLCO ≥ 80%. | Patients with DLCO ≥80% only will be followed at baseline and year 5. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Care | Other | Patients will followed during 5 years, and only 2 visits , baseline and 5 years |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline of Diffusion Capacity (DLCO) at 5 years | To determine the value of DLCO in COPD screening in smokers and ex-smokers with respiratory symptoms and normal spirometry (GOLD 0) | through study completion, an average of 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Risk factors associated to the development of COPD | Risk factors associated to the development of COPD | through study completion, an average of 5 years |
| Changes from baseline of inflammatory Markers at 2 and 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects over 18 smokers or ex-smokers with cumulative exposure ≥ 10 a / p (years /pack) with respiratory symptoms presenting normal spirometry
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cruz González, PhD | Contact | 0034961973677 | cruz.gonzalez@uv.es |
| Name | Affiliation | Role |
|---|---|---|
| Cruz González, PhD | Hospital ClÃnico Universitario de Valencia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnico Universitario de Valencia | Valencia | Valencia | 46010 | Spain |
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| Standard Care plus oxidative stress study plus inflammation biomarkers study | Other | Patients will followed during 5 years, Annual follo-up visits will be carried out during this period |
|
To Study soluble receptors involved in inflammation processes and tissue repair in early disease stages.
| 2 and 5 years |
| Oxidative stress | To Study of oxidative stress parameters in early disease stages | through study completion, an average of 5 years |
| Diffusion study | To Characterize patients in stage 0 of GOLD with impaired diffusion | through study completion, an average of 5 years |
| Changes from baseline of High Resolution Computed Tomography (HRTC) at 5 years | To determine changes in HRCT to identify subgroups of patients with different clinical and evolutionary trajectories | Baseline and 5 years |
| Airflow limitation Study | To Investigate the contribution of measuring lung volumes for the diagnosis of COPD when there is no evidence of airflow limitation in spirometry (GOLD 0). | through study completion, an average of 5 years |
| Gender differences in value of diffusion (DLCO) | To assess if there are differences between men and women with diffusion disorder | through study completion, an average of 5 years |
| Childhood background | To assess whether factors, such as the effect of lung development during childhood and adolescence, bronchial hyperreactivity and / or the role of infections influences the risk of developing the disease or its progression. | Baseline |
| Comorbidity | To characterize the comorbidities associated with GOLD 0 patients and altered diffusion. | through study completion, an average of 5 years |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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