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

NCT01750658 | Completed

• 1 other identifier: Nº IB 497/05
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COPD

Keywords

Biomarkers; Exacerbations; COPD

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Characterization and severity of pulmonary and systemic inflammation

  One year

• Paired, Individual changes in pulmonary and systemic inflammation

  One year

Study Arms (1)

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

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cimera: lead
• Hospital Son Espases: collaborator
• HOSPITAL DOCE DE OCTUBRE: collaborator
• Hospital Clinic of Barcelona: collaborator
• Germans Trias i Pujol Hospital: collaborator
• Hospital Universitario Fundación Jiménez Díaz: collaborator
• Hospital La Fe de Valencia: collaborator
• Hospital de Galdakao: collaborator
• Hospital del Mar: collaborator

Study Sites (1)

Hospital Universitari Son Espases

Palma de Mallorca, Balearic Islands, 07010, Spain

Location

Related Publications (1)

• 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.

  PMID: 28954781 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2012
• First Posted: December 17, 2012
• Study Start: September 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 17, 2012

Record last verified: 2012-12

Locations

ES (1)