EARLY COPD: Determinants of Onset and Progression of COPD in Young Adults

Sponsor

Borja Cosio (Other)

Overall Status

Unknown status

CT.gov ID

NCT02352220

Collaborator

Spanish Research Center for Respiratory Diseases (Other), Hospital Son Espases (Other), Hospital Clinic of Barcelona (Other), Hospital del Mar (Other), Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz (Other), Hospital Universitario 12 de Octubre (Other), Hospital Parc Taulí, Sabadell (Other), Hospitales Universitarios Virgen del Rocío (Other), Hospital Universitari de Bellvitge (Other), Hospital Arnau de Vilanova (Other), Hospital Universitario Central de Asturias (Other), University Hospital of the Nuestra Señora de Candelaria (Other), University Hospital A Coruña (Other), Barcelona Institute for Global Health (Other), Boehringer Ingelheim (Industry)

310

Enrollment

Location

Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
COPD

Study Design

Study Type:

Observational

Actual Enrollment :

310 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Early COPD: Determinants of Onset and Progression of COPD in Young Adults

Study Start Date :

Jan 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Outcome Measures

Primary Outcome Measures

Differences in lung function measures between cases and controls [At time of visit 1 (cross-sectional)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

**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 …

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Son Espases	Palma Mallorca	Mallorca	Spain

Sponsors and Collaborators

Borja Cosio
Spanish Research Center for Respiratory Diseases
Hospital Son Espases
Hospital Clinic of Barcelona
Hospital del Mar
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Hospital Universitario 12 de Octubre
Hospital Parc Taulí, Sabadell
Hospitales Universitarios Virgen del Rocío
Hospital Universitari de Bellvitge
Hospital Arnau de Vilanova
Hospital Universitario Central de Asturias
University Hospital of the Nuestra Señora de Candelaria
University Hospital A Coruña
Barcelona Institute for Global Health
Boehringer Ingelheim

Investigators

Principal Investigator: Borja Cosio, Medical Doctor, Spanish Research Center for Respiratory Diseases

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Borja Cosio, Dr Fco. de Borja García-Cosío Piqueras, Hospital Son Espases

ClinicalTrials.gov Identifier:

NCT02352220

Other Study ID Numbers:

PI13-02225

First Posted:

Feb 2, 2015

Last Update Posted:

Feb 27, 2018

Last Verified:

Feb 1, 2018

Study Results

No Results Posted as of Feb 27, 2018