GOLD 0 - DLCO 1: A Look Beyond the Obstruction. Is Spirometry Enough for COPD (Chronic Obstructive Pulmonary Disease) Screening?
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease
- Interventions
- Other: Standard Care plus oxidative stress study plus inflammation biomarkers studyOther: Standard Care
- Registration Number
- NCT05016466
- Lead Sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 236
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group I. Patients with DLCO <80%. Standard Care plus oxidative stress study plus inflammation biomarkers study Patients with DLCO \<80% will be followed at baseline and once a year during the study Group II. Patients with DLCO ≥ 80%. Standard Care Patients with DLCO ≥80% only will be followed at baseline and year 5.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Comorbidity through study completion, an average of 5 years To characterize the comorbidities associated with GOLD 0 patients and altered diffusion.
Risk factors associated to the development of COPD through study completion, an average of 5 years Risk factors associated to the development of COPD
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).
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.
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
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
Trial Locations
- Locations (1)
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Valencian Community, Spain