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

Fundación para la Investigación del Hospital Clínico de Valencia

Status: Not yet enrolling

Conditions: COPD, Chronic Obstructive Pulmonary Disease

Treatments: Other: Standard Care; Other: Standard Care plus oxidative stress study plus inflammation biomarkers study

Study type: Observational

Funder types: Other

Identifiers

NCT05016466

GOLD 0-DLCO 1

Details and patient eligibility

About

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.

Enrollment: 236 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

236 participants in 2 patient groups

Group I. Patients with DLCO <80%.

Description:

Patients with DLCO \<80% will be followed at baseline and once a year during the study

Treatment:

Other: Standard Care plus oxidative stress study plus inflammation biomarkers study

Group II. Patients with DLCO ≥ 80%.

Description:

Patients with DLCO ≥80% only will be followed at baseline and year 5.

Treatment:

Other: Standard Care