Study of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations In Spain
NCT ID: NCT01750658
Last Updated: 2012-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
99 participants
OBSERVATIONAL
2006-09-30
2009-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_CROSSOVER
PROSPECTIVE
Study Groups
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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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
40 Years
80 Years
ALL
No
Sponsors
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Hospital Son Espases
OTHER
HOSPITAL DOCE DE OCTUBRE
UNKNOWN
Hospital Clinic of Barcelona
OTHER
Germans Trias i Pujol Hospital
OTHER
Hospital Universitario Fundación Jiménez Díaz
OTHER
Hospital La Fe de Valencia
UNKNOWN
Hospital de Galdakao
OTHER
Hospital del Mar
OTHER
Cimera
NETWORK
Responsible Party
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Locations
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Hospital Universitari Son Espases
Palma de Mallorca, Balearic Islands, Spain
Countries
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References
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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.
Other Identifiers
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Nº IB 497/05
Identifier Type: -
Identifier Source: org_study_id