Trials Sponsors Conditions Drugs Pricing

Conditions

COPD, Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

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 Outcomes (9)

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
2 and 5 years
Oxidative stress
through study completion, an average of 5 years
Diffusion study
through study completion, an average of 5 years
Changes from baseline of High Resolution Computed Tomography (HRTC) at 5 years
Baseline and 5 years
+4 more secondary outcomes

Study Arms (2)

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

Group II. Patients with DLCO ≥ 80%.

Patients with DLCO ≥80% only will be followed at baseline and year 5.

Other: Standard Care

Interventions

Standard CareOther

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

Group II. Patients with DLCO ≥ 80%.

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

Group I. Patients with DLCO <80%.

Eligibility Criteria

Age18 Years - 99 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

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

You may qualify if:

Age ≥18 years. The participant or his / her legal representative is willing and able to give informed consent to participate in the study.

Sponsors & Collaborators

Fundación para la Investigación del Hospital Clínico de Valencia
Otherlead

Study Sites (1)

Hospital Clínico Universitario de Valencia

Valencia, Valencia, 46010, Spain

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services Administration

Study Officials

Cruz González, PhD
Hospital Clínico Universitario de Valencia
STUDY DIRECTOR

Enrollment

236 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 26, 2021

First Posted

August 23, 2021

Study Start

September 10, 2021

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (2)

Group I. Patients with DLCO <80%.

Group II. Patients with DLCO ≥ 80%.

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (2)

Group I. Patients with DLCO <80%.

Group II. Patients with DLCO ≥ 80%.

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations