Determinants of Onset and Progression of COPD in Young Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

310 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

COPD (Chronic Obstructive Pulmonary Disease) is a Public Health problem due to its impact in the patient's quality of life, high prevalence, growing incidence and socioeconomic implication. COPD natural history and first stages determinants are unknown. Knowing them will help to understand the natural history of the disease and to design interventions that can modify the prognosis of the disease.

Study objectives: (1) To characterize an early COPD population from a multidimensional point of view including demographic, social, family and clinical data, lung function, exercise capacity, image, microbiology, quality of life, exacerbations, comorbidities and blood and sputum biomarkers. (2) To compare this patients with smoking subjects, with normal lung function, matched by age, sex and site. (3) To create an early COPD cohort to be followed in the future to understand the complete natural history of the disease.

Methods: Design: multicenter cross-sectional study that will allow establishing a well-characterized cohort of early COPD patients for later follow-up. Recruitment will be done in Primary Care settings. Subjects: smokers (\> 10 packs year) between 35-50 years old with a spirometry (normal or obstructive) done in the last year. Diagnosis of COPD will be based on the smoking history and a postbronchodilator test FEV1(Forced Expiratory Volume in the first second) / FVC(Forced Vital Capacity) \< 70%. Age, sex and site matched 'healthy' smoker controls will be compared with the COPD cases. Variables that will be collected in the reference hospitals are: health questionnaires, lung function test, exercise capacity, blood and sputum samples, and low dose CT-scan. Statistical analysis: early COPD patient's characteristics will be described and then, will be compared, with control subjects through a conditional multiple logistic regression analysis.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Endothelial Dysfunction in Chronic Obstructive Pulmonary Disease

NCT00831220

Chronic Obstructive Pulmonary Disease Endothelial Dysfunction

COMPLETED

COPD Readmissions Prediction- ReCOPD Project

NCT03227211

Pulmonary Disease, Chronic Obstructive, Severe Early-Onset

COMPLETED

European Non-interventional Study in Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT00722267

Chronic Obstructive Pulmonary Disease (COPD)

COMPLETED

Small Bioactive Molecules in Early COPD Diseases

NCT04950023

Chronic Obstructive Pulmonary Disease

UNKNOWN

A Study for the Assessment of the Words Used by Patients and Physicians to Express the Symptoms of Chronic Obstructive Pulmonary Disease (COPD)

NCT01219946

Chronic Obstructive Pulmonary Disease

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

COPD case:

* Subjects between 35 and 50 years
* Post-bronchodilator spirometry with FEV1/FVC \<70%
* Smoker or ex-smoker with total cumulative exposure \> 10 pack-years

Smoking control:

* Subjects between 35 and 50 years
* Post-bronchodilator spirometry with FEV1/FVC \>=70%
* Smoker or ex-smoker with total cumulative exposure\> 10 pack-years

Exclusion Criteria

For cases:

* Chronic inflammatory diseases including autoimmune diseases under treatment.
* HIV
* Active cancer
* Cystic or saccular bronchiectasis
* Conditions that may interfere with follow-up: frequent change of residence, psychiatric disorders, dementia…

For controls:

* Chronic inflammatory diseases including autoimmune diseases under treatment
* HIV
* Active cancer
* Chronic respiratory diseases:
* active tuberculosis
* interstitial lung diseases
* cystic or saccular bronchiectasis
* ever diagnosed asthma
* deficit of alpha1-antitrypsin
* Conditions that may interfere with follow-up: frequent change of residence, psychiatric disorders, dementia …

Minimum Eligible Age

35 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes