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

Cimera

Status: Completed

Conditions: COPD

Study type: Observational

Funder types: Other; NETWORK

Identifiers

NCT01750658

Nº IB 497/05

Details and patient eligibility

About

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

Full 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.

Enrollment: 99 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

99 participants in 1 patient group

COPD

Description:

COPD patients admitted in any of the participating ECOS hospitals due to a COPD exacerbation. 1. - External factors. The episodes of COPD exacerbations are associated to exogenous factors (pollution, change of ambient temperature, humidity, infections). The prevalence of environmental contamination and infections is higher than expected. 2. - Endogenous factors. These factors (hyperinflation, pulmonary embolism, cardiac dysfunction, mucus hypersecretion) are present in a proportion higher than expected 3. - During exacerbations of COPD serum markers of inflammation and autoimmunity are high relative to baseline in COPD and decrease progressively during the follow-up, after controlling the acute episode