NCT05016466

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 236 (estimated)
• Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COPD, Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
OTHER	Standard Care	Patients will followed during 5 years, and only 2 visits , baseline and 5 years
OTHER	Standard 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

Timeline

• Start date: 2021-09-10
• Primary completion: 2025-02-10
• Completion: 2025-12-31
• First posted: 2021-08-23
• Last updated: 2021-08-23

Locations

1 site across 1 country: Spain