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Completed

NCT Number: NCT05016466

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

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Key information

Conditions

COPD, Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard care

Other

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

Standard Care plus oxidative stress study plus inflammation biomarkers study

Other

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

Primary outcomes

  1. Changes from baseline of Diffusion Capacity (DLCO) at 5 years

    Time frame: through study completion, an average of 5 years

    To determine the value of DLCO in COPD screening in smokers and ex-smokers with respiratory symptoms and normal spirometry (GOLD 0)

Secondary outcomes

  1. Risk factors associated to the development of COPD

    Time frame: through study completion, an average of 5 years

    Risk factors associated to the development of COPD

  2. Changes from baseline of inflammatory Markers at 2 and 5 years

    Time frame: 2 and 5 years

    To Study soluble receptors involved in inflammation processes and tissue repair in early disease stages.

  3. Oxidative stress

    Time frame: through study completion, an average of 5 years

    To Study of oxidative stress parameters in early disease stages

  4. Diffusion study

    Time frame: through study completion, an average of 5 years

    To Characterize patients in stage 0 of GOLD with impaired diffusion

  5. Changes from baseline of High Resolution Computed Tomography (HRTC) at 5 years

    Time frame: Baseline and 5 years

    To determine changes in HRCT to identify subgroups of patients with different clinical and evolutionary trajectories

  6. Airflow limitation Study

    Time frame: through study completion, an average of 5 years

    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).

  7. Gender differences in value of diffusion (DLCO)

    Time frame: through study completion, an average of 5 years

    To assess if there are differences between men and women with diffusion disorder

  8. Childhood background

    Time frame: Baseline

    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.

  9. Comorbidity

    Time frame: through study completion, an average of 5 years

    To characterize the comorbidities associated with GOLD 0 patients and altered diffusion.

Sponsors and collaborators

Lead sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Aug 23, 2021
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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