GOLD 0 - DLCO 1: A Look Beyond the Obstruction. Is Spirometry Enough for COPD (Chronic Obstructive Pulmonary Disease) Screening?

Study Overview
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Brief Summary
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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: Group I. Patients with DLCO <80%. Group II Patients with DLCO≥80%. Both groups will be followed for 5 years.

Official Title
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GOLD 0 - DLCO 1: A Look Beyond the Obstruction. Is Spirometry Enough for COPD Screening?

Conditions
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COPD, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Other: Standard Care
* Other: Standard Care plus oxidative stress study plus inflammation biomarkers study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years. The participant or his / her legal representative is willing and able to give informed consent to participate in the study. Female or male patients with age equal to or greater than 18 years. Smokers or ex-smokers with cumulative exposure ≥ 10 a / p Respiratory symptoms Normal spirometry. Exclusion Criteria: Age under 18 years. Participation in another clinical study. Patients with a life expectancy of less than 2 years due to neoplasms or other serious systemic diseases. Refusal to sing informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group I. Patients with DLCO <80%.<br>Patients with DLCO <80% will be followed at baseline and once a year during the study | Other: Standard Care plus oxidative stress study plus inflammation biomarkers study<br>* Patients will followed during 5 years, Annual follo-up visits will be carried out during this period<br>|
| Group II. Patients with DLCO ≥ 80%.<br>Patients with DLCO ≥80% only will be followed at baseline and year 5. | Other: Standard Care<br>* Patients will followed during 5 years, and only 2 visits , baseline and 5 years<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |