Clinical trial NCT05016466: GOLD 0 - DLCO 1: A Look Beyond the Obstruction. Is Spirometry Enough for COPD (Chronic Obstructive Pulmonary Disease) Screening?
Official title: GOLD 0 - DLCO 1: A Look Beyond the Obstruction. Is Spirometry Enough for COPD Screening?
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: COPD, Chronic Obstructive Pulmonary Disease
Lead sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Sponsor class: OTHER
First posted: 2021-08-23
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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:

* Group I. Patients with DLCO \<80%.
* Group II Patients with DLCO≥80%.

Both groups will be followed for 5 years.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes from baseline of Diffusion Capacity (DLCO) at 5 years
timeFrame: through study completion, an average of 5 years
Secondary outcomes:
measure: Risk factors associated to the development of COPD
timeFrame: through study completion, an average of 5 years
measure: Changes from baseline of inflammatory Markers at 2 and 5 years
timeFrame: 2 and 5 years
measure: Oxidative stress
timeFrame: through study completion, an average of 5 years
measure: Diffusion study
timeFrame: through study completion, an average of 5 years
measure: Changes from baseline of High Resolution Computed Tomography (HRTC) at 5 years
timeFrame: Baseline and 5 years
measure: Airflow limitation Study
timeFrame: through study completion, an average of 5 years
measure: Gender differences in value of diffusion (DLCO)
timeFrame: through study completion, an average of 5 years
measure: Childhood background
timeFrame: Baseline
measure: Comorbidity
timeFrame: through study completion, an average of 5 years
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
state: Valencian Community
Study officials:
affiliation: Hospital Clínico Universitario de Valencia
name: Cruz González, PhD
role: STUDY_DIRECTOR
References: