GOLD 0 - DLCO 1: A Look Beyond the Obstruction. Is Spirometry Enough for COPD (Chronic Obstructive Pulmonary Disease) Screening?
Study Details
Study Description
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:
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Group I. Patients with DLCO <80%.
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Group II Patients with DLCO≥80%.
Both groups will be followed for 5 years.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- Changes from baseline of Diffusion Capacity (DLCO) at 5 years [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 Outcome Measures
- Risk factors associated to the development of COPD [through study completion, an average of 5 years]
Risk factors associated to the development of COPD
- Changes from baseline of inflammatory Markers at 2 and 5 years [2 and 5 years]
To Study soluble receptors involved in inflammation processes and tissue repair in early disease stages.
- Oxidative stress [through study completion, an average of 5 years]
To Study of oxidative stress parameters in early disease stages
- Diffusion study [through study completion, an average of 5 years]
To Characterize patients in stage 0 of GOLD with impaired diffusion
- Changes from baseline of High Resolution Computed Tomography (HRTC) at 5 years [Baseline and 5 years]
To determine changes in HRCT to identify subgroups of patients with different clinical and evolutionary trajectories
- Airflow limitation Study [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).
- Gender differences in value of diffusion (DLCO) [through study completion, an average of 5 years]
To assess if there are differences between men and women with diffusion disorder
- Childhood background [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.
- Comorbidity [through study completion, an average of 5 years]
To characterize the comorbidities associated with GOLD 0 patients and altered diffusion.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥18 years. The participant or his / her legal representative is willing and able to give informed consent to participate in the study.
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Female or male patients with age equal to or greater than 18 years.
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Smokers or ex-smokers with cumulative exposure ≥ 10 a / p
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Respiratory symptoms
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Normal spirometry.
Exclusion Criteria:
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Age under 18 years.
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Participation in another clinical study.
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Patients with a life expectancy of less than 2 years due to neoplasms or other serious systemic diseases.
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Refusal to sing informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Clínico Universitario de Valencia | Valencia | Valencian Community | Spain | 46010 |
Sponsors and Collaborators
- Fundación para la Investigación del Hospital Clínico de Valencia
Investigators
- Study Director: Cruz González, PhD, Hospital Clínico Universitario de Valencia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GOLD 0-DLCO 1