COPD, Chronic Obstructive Pulmonary DiseaseNCT05016466
GOLD 0 - DLCO 1: A Look Beyond the Obstruction. Is Spirometry Enough for COPD (Chronic Obstructive Pulmonary Disease) Screening?
An observational study of COPD, Chronic Obstructive Pulmonary Disease, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- COPD, Chronic Obstructive Pulmonary Disease
- How many people
- 236 participants
- Where
- 1 siteSpain
- Study dates
- 10 Sep 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects over 18 smokers or ex-smokers with cumulative exposure ≥ 10 a / p (years /pack) with respiratory symptoms presenting normal spirometry
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Clínico Universitario de Valencia
Valencia, Valencia, 46010
About this study
Official title: 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.
- Being tested
- Standard Care, Standard Care plus oxidative stress study plus inflammation biomarkers study
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard CareOther
Patients will followed during 5 years, and only 2 visits , baseline and 5 years
Standard Care plus oxidative stress study plus inflammation biomarkers studyOther
Patients will followed during 5 years, Annual follo-up visits will be carried out during this period
| Study group | Role | What they receive |
|---|---|---|
| Group I. Patients with DLCO <80%. | Patients with DLCO <80% will be followed at baseline and once a year during the study Receives: Other: Standard Care plus oxidative stress study plus inflammation biomarkers study | |
| Group II. Patients with DLCO ≥ 80%. | Patients with DLCO ≥80% only will be followed at baseline and year 5. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: through study completion, an average of 5 years
Secondary outcomes (9)
Risk factors associated to the development of COPD
Risk factors associated to the development of COPD
Measured: 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.
Measured: 2 and 5 years
Oxidative stress
To Study of oxidative stress parameters in early disease stages
Measured: through study completion, an average of 5 years
Diffusion study
To Characterize patients in stage 0 of GOLD with impaired diffusion
Measured: 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
Measured: 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).
Measured: 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
Measured: 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.
Measured: Baseline
Comorbidity
To characterize the comorbidities associated with GOLD 0 patients and altered diffusion.
Measured: through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start10 Sep 2021
- Primary completion10 Feb 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD, Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cruz González, PhD, Study director, Hospital Clínico Universitario de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05016466
- Sponsor's protocol ID
- GOLD 0-DLCO 1
- Status last verified
- Sep 2026
- First submitted
- 26 Jul 2021
- Last updated
- 4 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GOLD 0 - DLCO 1: A Look Beyond the Obstruction. Is Spirometry Enough for COPD Screening?
- ClinicalTrials.gov ID
- NCT05016466
- Acronym / sponsor ID
- GOLD 0-DLCO 1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 10 Feb 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 23 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I. Patients with DLCO <80%. | – | Other: Standard Care plus oxidative stress study plus inflammation biomarkers studyPatients with DLCO <80% will be followed at baseline and once a year during the study |
| Group II. Patients with DLCO ≥ 80%. | – | Other: Standard CarePatients with DLCO ≥80% only will be followed at baseline and year 5. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects over 18 smokers or ex-smokers with cumulative exposure ≥ 10 a / p (years /pack) with respiratory symptoms presenting normal spirometry
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard CarePatients will followed during 5 years, and only 2 visits , baseline and 5 years | Other | Group II. Patients with DLCO ≥ 80%. |
| Standard Care plus oxidative stress study plus inflammation biomarkers studyPatients will followed during 5 years, Annual follo-up visits will be carried out during this period | Other | Group I. Patients with DLCO <80%. |
Primary outcome
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)
9 secondary outcomes
Risk factors associated to the development of COPD
Time frame: through study completion, an average of 5 years
Changes from baseline of inflammatory Markers at 2 and 5 years
Time frame: 2 and 5 years
Oxidative stress
Time frame: through study completion, an average of 5 years
Diffusion study
Time frame: through study completion, an average of 5 years
Changes from baseline of High Resolution Computed Tomography (HRTC) at 5 years
Time frame: Baseline and 5 years
Airflow limitation Study
Time frame: through study completion, an average of 5 years
Gender differences in value of diffusion (DLCO)
Time frame: through study completion, an average of 5 years
Childhood background
Time frame: Baseline
Comorbidity
Time frame: through study completion, an average of 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cruz González, PhD study director
Hospital Clínico Universitario de Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, Chronic Obstructive Pulmonary Disease, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline of Diffusion Capacity (DLCO) at 5 years (time frame: through study completion, an average of 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.