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

NCT ID: NCT05016466

Last Updated: 2021-08-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 236 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-10
• Study Completion Date: 2025-12-31

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.

Conditions

COPD, Chronic Obstructive Pulmonary Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group I. Patients with DLCO <80%.

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

Standard Care plus oxidative stress study plus inflammation biomarkers study

Intervention Type: OTHER

Patients will followed during 5 years, Annual follo-up visits will be carried out during this period

Group II. Patients with DLCO ≥ 80%.

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

Standard Care

Intervention Type: OTHER

Patients will followed during 5 years, and only 2 visits , baseline and 5 years

Interventions

Standard Care

Patients will followed during 5 years, and only 2 visits , baseline and 5 years

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación para la Investigación del Hospital Clínico de Valencia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cruz González, PhD

Role: STUDY_DIRECTOR

Hospital Clínico Universitario de Valencia

Locations

Hospital Clínico Universitario de Valencia

Valencia, Valencia, Spain

Countries

Spain

Central Contacts

Cruz González, PhD

Role: CONTACT

cruz.gonzalez@uv.es

0034961973677

Facility Contacts

cruz Gonzalez, PhD

Role: primary

cruz.gonzalez@uv.es

0034961973977

Other Identifiers

GOLD 0-DLCO 1

Identifier Type: -

Identifier Source: org_study_id