Clinical trial NCT01750658: Study of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations In Spain
Official title: ECOS: A Study of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations In Spain (o Estudio de Las Exacerbaciones de la EPOC en España)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Keywords: Biomarkers
Exacerbations
COPD
Lead sponsor: Cimera
Sponsor class: NETWORK
Collaborators: name: Hospital Son Espases
name: HOSPITAL DOCE DE OCTUBRE
name: Hospital Clinic of Barcelona
name: Germans Trias i Pujol Hospital
name: Hospital Universitario Fundación Jiménez Díaz
name: HOSPITAL LA FE VALENCIA
name: Hospital de Galdakao
name: Hospital del Mar
First posted: 2012-12-17
Enrollment: 99
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients admitted in any of the participating ECOS hospitals with a diagnosis of COPD exacerbation

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

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Time to new COPD exacerbation
timeFrame: One year
Secondary outcomes:
measure: Characterization and severity of pulmonary and systemic inflammation
timeFrame: One year
measure: Paired, Individual changes in pulmonary and systemic inflammation
timeFrame: One year
Other outcomes:
Locations:
city: Palma de Mallorca
country: Spain
facility: Hospital Universitari Son Espases
state: Illes Balears
Study officials:
References:
citation: Noell G, Cosio BG, Faner R, Monso E, Peces-Barba G, de Diego A, Esteban C, Gea J, Rodriguez-Roisin R, Garcia-Nunez M, Pozo-Rodriguez F, Kalko SG, Agusti A. Multi-level differential network analysis of COPD exacerbations. Eur Respir J. 2017 Sep 27;50(3):1700075. doi: 10.1183/13993003.00075-2017. Print 2017 Sep.