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

COPD, Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05016466
• Other study ID #: GOLD 0-DLCO 1
• Status: Not yet recruiting
• Start date: September 10, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2021
• Source: Fundación para la Investigación del Hospital Clínico de Valencia
• Contact: Cruz González, PhD
• Phone: 0034961973677
• Email: cruz.gonzalez[@]uv.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 236
• Est. completion date: December 31, 2025
• Est. primary completion date: February 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• COPD, Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Standard Care
Patients will followed during 5 years, and only 2 visits , baseline and 5 years
• 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

Locations

Country	Name	City	State
Spain	Hospital Clínico Universitario de Valencia	Valencia	Valencian Community

Sponsors (1)

Lead Sponsor	Collaborator
Fundación para la Investigación del Hospital Clínico de Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline of Diffusion Capacity (DLCO) at 5 years	To determine the value of DLCO in COPD screening in smokers and ex-smokers with respiratory symptoms and normal spirometry (GOLD 0)	through study completion, an average of 5 years
Secondary	Risk factors associated to the development of COPD	Risk factors associated to the development of COPD	through study completion, an average of 5 years
Secondary	Changes from baseline of inflammatory Markers at 2 and 5 years	To Study soluble receptors involved in inflammation processes and tissue repair in early disease stages.	2 and 5 years
Secondary	Oxidative stress	To Study of oxidative stress parameters in early disease stages	through study completion, an average of 5 years
Secondary	Diffusion study	To Characterize patients in stage 0 of GOLD with impaired diffusion	through study completion, an average of 5 years
Secondary	Changes from baseline of High Resolution Computed Tomography (HRTC) at 5 years	To determine changes in HRCT to identify subgroups of patients with different clinical and evolutionary trajectories	Baseline and 5 years
Secondary	Airflow limitation Study	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).	through study completion, an average of 5 years
Secondary	Gender differences in value of diffusion (DLCO)	To assess if there are differences between men and women with diffusion disorder	through study completion, an average of 5 years
Secondary	Childhood background	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.	Baseline
Secondary	Comorbidity	To characterize the comorbidities associated with GOLD 0 patients and altered diffusion.	through study completion, an average of 5 years