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?

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.

Study Overview

• Status: Not yet recruiting
• Conditions: COPD, Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: Standard Care plus oxidative stress study plus inflammation biomarkers study; Other: Standard Care

• Study Type: Observational
• Enrollment (Anticipated): 236

Contacts and Locations

• Study Contact: Name: Cruz González, PhD; Phone Number: 0034961973677; Email: cruz.gonzalez@uv.es

Study Locations

• Spain
  • Valencian Community
    • Valencia, Valencian Community, Spain, 46010
      • Hospital Clinico Universitario de Valencia
      • Contact: cruz Gonzalez, PhD; Phone Number: 0034961973977; Email: cruz.gonzalez@uv.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects over 18 smokers or ex-smokers with cumulative exposure ≥ 10 a / p (years /pack) with respiratory symptoms presenting normal spirometry

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group I. Patients with DLCO <80%.; Patients with DLCO <80% will be followed at baseline and once a year during the study	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
Group II. Patients with DLCO ≥ 80%.; Patients with DLCO ≥80% only will be followed at baseline and year 5.	Other: Standard Care; Patients will followed during 5 years, and only 2 visits , baseline and 5 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk factors associated to the development of COPD	Risk factors associated to the development of COPD	through study completion, an average of 5 years
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
Oxidative stress	To Study of oxidative stress parameters in early disease stages	through study completion, an average of 5 years
Diffusion study	To Characterize patients in stage 0 of GOLD with impaired diffusion	through study completion, an average of 5 years
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
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
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
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
Comorbidity	To characterize the comorbidities associated with GOLD 0 patients and altered diffusion.	through study completion, an average of 5 years

Collaborators and Investigators

• Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
• Investigators: Study Director: Cruz González, PhD, Hospital Clinico Universitario de Valencia

Study record dates

Study Major Dates

• Study Start (Anticipated): September 10, 2021
• Primary Completion (Anticipated): February 10, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: July 26, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (Actual): August 23, 2021

Study Record Updates

• Last Update Posted (Actual): August 23, 2021
• Last Update Submitted That Met QC Criteria: August 16, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: GOLD 0-DLCO 1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No