Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborators:
Hospital Son Espases
HOSPITAL DOCE DE OCTUBRE
Hospital Clinic of Barcelona
Germans Trias i Pujol Hospital
HOSPITAL F. JIMÉNEZ DÍAZ
HOSPITAL LA FE VALENCIA
HOSPITAL DE GALDÁCANO
Hospital del Mar
Information provided by (Responsible Party):
Cimera
ClinicalTrials.gov Identifier:
NCT01750658
First received: November 14, 2012
Last updated: December 13, 2012
Last verified: December 2012
  Purpose

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


Condition
COPD

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: ECOS: A Study of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations In Spain (o Estudio de Las Exacerbaciones de la EPOC en España)

Resource links provided by NLM:


Further study details as provided by Cimera:

Primary Outcome Measures:
  • Time to new COPD exacerbation [ Time Frame: One year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Characterization and severity of pulmonary and systemic inflammation [ Time Frame: One year ] [ Designated as safety issue: No ]
    Describe the biological characterization and severity of pulmonary and systemic inflammation, by means of presence/absence of inflamatory markers, their combination and their concentrations

  • Paired, Individual changes in pulmonary and systemic inflammation [ Time Frame: One year ] [ Designated as safety issue: No ]
    Within individuals, characterization and severity of pulmonary and systemic inflammation, by means of presence/absence of inflamatory markers, their combination and their concentrations


Biospecimen Retention:   Samples Without DNA

Blood


Enrollment: 99
Study Start Date: September 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
COPD

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

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

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

COPD patients admitted in any of the participating ECOS hospitals with a diagnosis of COPD exacerbation

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01750658

Locations
Spain
Hospital Universitari Son Espases
Palma de Mallorca, Illes Balears, Spain, 07010
Sponsors and Collaborators
Cimera
Hospital Son Espases
HOSPITAL DOCE DE OCTUBRE
Hospital Clinic of Barcelona
Germans Trias i Pujol Hospital
HOSPITAL F. JIMÉNEZ DÍAZ
HOSPITAL LA FE VALENCIA
HOSPITAL DE GALDÁCANO
Hospital del Mar
  More Information

No publications provided

Responsible Party: Cimera
ClinicalTrials.gov Identifier: NCT01750658     History of Changes
Other Study ID Numbers: Nº IB 497/05
Study First Received: November 14, 2012
Last Updated: December 13, 2012
Health Authority: Spain: CEI Illes Balears

Keywords provided by Cimera:
Biomarkers
Exacerbations
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 27, 2014