Study of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations In Spain

COPD Clinical Trial

— ECOS  

Official title:

ECOS: A Study of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations In Spain (o Estudio de Las Exacerbaciones de la EPOC en España)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01750658
• Other study ID #: Nº IB 497/05
• Status: Completed
• Phase: N/A
• First received: November 14, 2012
• Last updated: December 13, 2012
• Start date: September 2006
• Est. completion date: December 2009

Study information

• Verified date: December 2012
• Source: Cimera
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: CEI Illes Balears
• Study type: Observational

Clinical Trial Summary

ECOS is a cross-sectional, observational, longitudinal, multicenter study enrolling 100-200 patients during a COPD exacerbation.

Description:

Patients will be followed for 12 months. Information to be collected includes clinical, analytical, immunological, microbiological, hemodynamic, imaging, environmental, social and other blood markers of inflammation (IL-8, IL-6, TNF, TNF-alpha, endothelin-1, SLPI, IL10, TGF-beta and markers oxidative stress (TEAC)), and sputum (cell count, IL-6, IL-8, SLPI, ET 1, IL10).

Each center will collect clinical data, blood gas, microbiological and functional data for their patients, which will be centralized through the website of the Red Respira (www.redrespira.net).

A frozen serum sample and another of frozen sputum supernatant will be sent to the coordinating center (Palma de Mallorca).

Statistical analysis will include descriptive statistics: mean, standard deviation and range. Comparison of quantitative variables to be assessed using Student's t-test and ANOVA. Correlations between variables will be performed using bivariate analyzes (Pearson's linear correlation coefficient) and multivariate (multiple regression) analyses, among others.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Men and women

• Ages 40-80 years

• Diagnosis of COPD (according to ATS/ERS consensus guidelines)

• Smoking history = 10 pack years

• Hospitalization for exacerbation of COPD

Exclusion Criteria:

• Pneumonia.

• Pneumothorax.

• Severe comorbidities, such as:

• -Advanced cancer.

• -Pulmonary tuberculosis, which affects more than one third of the total lung parenchyma.

• -Pneumonectomy.

• -Previous diagnosis of left heart failure.

• -Cardiomyopathy with ventricular dysfunction (ejection fraction <45%).

• -Chronic inflammatory diseases such as asthma, rheumatoid arthritis, pulmonary fibrosis and autoimmune diseases.

• Mechanical Ventilation.

• Existence of an exacerbation of COPD in the 4 weeks prior to admission.

• MRSA.

• History of thoracic/lung surgery in the past two years

• General weakness/malaise (difficulty in walking, lack of autonomy, etc.). that substantially hinders participation in the study, regardless of their willingness to participate.

• Mental incapacity according to the investigator judgment.

• Not resident in the province in which the hospital is located.

• Not fluent in Spanish

• Allergy to iodinated contrast

• Morbid obesity (BMI> 40)

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Spain	Hospital Universitari Son Espases	Palma de Mallorca	Illes Balears

Sponsors (9)

Lead Sponsor	Collaborator
Cimera	Germans Trias i Pujol Hospital, Hospital Clinic of Barcelona, Hospital de Galdakao, Hospital del Mar, HOSPITAL DOCE DE OCTUBRE, HOSPITAL F. JIMÉNEZ DÍAZ, HOSPITAL LA FE VALENCIA, Hospital Son Espases

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to new COPD exacerbation	From discharge of the current hospitalization, the time to a new COPD exacerbation will be estimated. The final aim of this study, descriptive, exploratory and hypothesis-generating, is to obtain a better understanding of the pathobiology of COPD exacerbations to eventually identify clinical correlations (biomarkers) that can help identify and diagnose them more accurately, and guide clinical practice for a more efficient way.	One year	No
Secondary	Characterization and severity of pulmonary and systemic inflammation	Describe the biological characterization and severity of pulmonary and systemic inflammation, by means of presence/absence of inflamatory markers, their combination and their concentrations	One year	No
Secondary	Paired, Individual changes in pulmonary and systemic inflammation	Within individuals, characterization and severity of pulmonary and systemic inflammation, by means of presence/absence of inflamatory markers, their combination and their concentrations	One year	No