COPD, Chronic Obstructive Pulmonary Disease
Conditions
Brief summary
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.
Interventions
OTHERStandard Care
Patients will followed during 5 years, and only 2 visits , baseline and 5 years
OTHERStandard Care plus oxidative stress study plus inflammation biomarkers study
Patients will followed during 5 years, Annual follo-up visits will be carried out during this period
Sponsors
Fundación para la Investigación del Hospital Clínico de Valencia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline of Diffusion Capacity (DLCO) at 5 years | through study completion, an average of 5 years | To determine the value of DLCO in COPD screening in smokers and ex-smokers with respiratory symptoms and normal spirometry (GOLD 0) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk factors associated to the development of COPD | through study completion, an average of 5 years | Risk factors associated to the development of COPD |
| Changes from baseline of inflammatory Markers at 2 and 5 years | 2 and 5 years | To Study soluble receptors involved in inflammation processes and tissue repair in early disease stages. |
| Oxidative stress | through study completion, an average of 5 years | To Study of oxidative stress parameters in early disease stages |
| Diffusion study | through study completion, an average of 5 years | To Characterize patients in stage 0 of GOLD with impaired diffusion |
| Changes from baseline of High Resolution Computed Tomography (HRTC) at 5 years | Baseline and 5 years | To determine changes in HRCT to identify subgroups of patients with different clinical and evolutionary trajectories |
| Airflow limitation Study | through study completion, an average of 5 years | 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). |
| Gender differences in value of diffusion (DLCO) | through study completion, an average of 5 years | To assess if there are differences between men and women with diffusion disorder |
| Childhood background | Baseline | 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. |
| Comorbidity | through study completion, an average of 5 years | To characterize the comorbidities associated with GOLD 0 patients and altered diffusion. |
Countries
Spain
Contacts
STUDY_DIRECTORCruz González, PhD
Hospital Clínico Universitario de Valencia
Outcome results
None listed