| AREA: Inflammation and repair in respiratory diseases (22 projects)
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Caracterización fenotípica y evolución de la enfermedad pulmonar obstructiva crónica (EPOC). |
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12/01/2004 |
Proyecto Financiado por FIS, AATRM, SEPAR, FUCAP y MaratóTV3 |
I.P. : Josep Mª Antó Boqué
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Objetivos: |
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PRINCIPALES:
1) Caracterizar la variabilidad fenotípica de las personas que ingresan por primera vez por agudización de una EPOC y proponer una clasificación en subtipos.
2) Estimar la asociación entre los subtipos definidos y la evolución clínica y funcional de la EPOC (pérdida de función pulmonar, hipoxemia, indicación de oxigenoterapia crónica domiciliaria, disminución de calidad de vida, etc)
3) Estimar la asociación entre los subtipos definidos y la utilización de recursos sanitarios (visitas a domicilio, a atención primaria, al
especialista, a urgencias, ingresos; tratamientos recibidos, etc)
4) Estimar la asociación entre los subtipos definidos y la mortalidad en los pacientes con EPOC.
5) Identificar los factores de riesgo de re-ingreso por agudización de la EPOC (habiendo reducido el sesgo de indicación por ser el reclutamiento durante el primer ingreso) y evaluar si existe interacción entre los subtipos definidos (objetivo 1) y los factores de riesgo.
SECUNDARIOS:
1) Reclutar y trazar una cohorte incipiente de pacientes con EPOC bien caracterizados fenotípicamente de manera que permita un seguimiento adicional (5-10 años) al incluido en el presente proyecto.
2) Crear un banco de muestras biológicas (suero, plasma, lavado
broncoalveolar, tejido bronquial, tejido muscular, piel) de una población de EPOC caracterizados fenotípicamente de manera exhaustiva.
3) Validar los criterios de estadiaje de la EPOC utilizados por ATS, ERS y GOLD. |
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Study on Exacerbations of COPD in Spain (Study ECOS). |
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Objetivos: |
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1. Describe the type, severity and frequency distribution of the pulmonary and systemic inflammatory burst that occur in a large and well characterized cohort of patients hospitalized because ECOPD
2. Compare them to those determined in the same patients when studied under conditions of clinical stability.
3. Relate the type and severity of this inflammatory burst to different triggers, patho-physiological consequences and symptoms perceived by the patients (Figure 1).
4. Investigate the potential role of several largely unexplored pathogenic mechanisms in ECOPD, such as auto-immunity, pulmonary microthrombosis and cryopyrin (see B1. Mechanisms of ECOPD).
5. Identify and validate (sensitivity, specificity, positive and negative predictive values) potential biomarkers that can be useful in future studies to characterize the heterogeneous nature of ECOPD
6. Relate the different patterns of inflammation, triggering mechanisms and pathophysiological consequences to death (and causes of death) and number and severity of ECOPD during the six months that follows hospitalization. |
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Polimorfismos genéticos de la ciclooxigenasa -2 en la predisposición y evolución de la fibrosis pulmonar idiopática. |
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Objetivos: |
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Investigar el papel de los polimorfismos del gen de la ciclooxigenasa-2 en la predisposición y evolución de la fibrosis pulmonar idiopática. |
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Condensación del exhalado con la respiración (CER): aspectos metodológicos y clínicos. |
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Objetivos: |
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Estandardizar al método de recogida Reducir la variabilidad intra e interindividual. Aumentar la concentración de sustancias en el CER. Identificar moléculas indicadoras para diferentes patologias pulmonares y de la vía aérea. |
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Bronchial colonization, inflammation and remodelling in chronic obstructive pulmonary disease. |
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| Colonización, inflamación y remodelado en la EPOC |
01/10/2004 |
Financiado por la Fundacion Catalana de Neumología |
I.P. : Eduard Monsó Molas
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Objetivos: |
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AIM: Bronchial microbiology, inflammation and remodelling during stable periods may be related to the evolution of COPD.
The aim of this cohort study is to determine in bronchial secretions and peripheral blood from COPD patients
1) the temporal variability of bacterial tipology, load, inflammatory (cellularity, mieloperoxidase, interleukin 1 beta, 6, 8 and 10, TNF alfa) and remodelling (metalloproteinase 9 and its inhibitor) markers in stable periods;
2) the variability of these markers in exacerbation, compared with the previous stable period; and;
3) the relationship between the markers, lung function and quality of life. |
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Severe Asthma, genetic aspects, molerculars and cellulars. |
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Objetivos: |
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The General Objective is to investigate the mechanisms involved in severe asthma.
The specific objectives of the study are:
1) Polymorphisms of eosinophilic regulatory factors genes that may predispose to developing robust inflammatory reactions.
2) Factors involved in the inflammatory aggressiveness of eosinophils.
3) Occupational and non-occupational allergen exposure potentially responsible for severity.
4) Alterations in the arachidonic acid metabolism that may explain the frequent association of severe asthma and aspirin-intolerance.
5) Role of associated diseases and habits (gastroesophageal reflux, smoking habit).
6) Abnormalities in glucocorticoid receptor functioning responsible for glucocorticoid insensitivity.
7) Psychological and social characteristics that may be responsible for: a) poor compliance, b) poor or abnormal perception of the disease and c) poor adaptation to the handicaps caused by the disease. |
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Systemic respiratory and peripheral) muscle injury induced by cigarette smoking: a causality study. |
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Objetivos: |
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This is an experimental study divided in three projects.
1).To evaluate the incidence and severity of both diaphragm and peripheral muscle injury induced by short-term cigarette smoke exposure.
2).To determine the potential role of methaloprotease activation and oxidative stress on systemic muscle injury induced by cigarette smoke.
3).To estimate the potential changes in the signal transduction elements that control muscle growth and maintenance (IGF-1, AKT) induced by cigarette smoking. |
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Study of oxygen and nitric oxide free radicals in ventilatory muscle dysfunction in two clinical situations;sepsis and airway obstruction in animal models. Evaluation of potential benefit of antioxidant therapy. |
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Objetivos: |
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Aim: 1.
To evaluate the level of oxidative stress in ventilatory muscles following LPS injection, and to investigate the preventive effects of NAC.
2. To evaluate the effects of IRB on oxidative stress and the expression of inflammatory mediators in ventilatory muscles, and to investigate the potential preventive effects of NAC on such a model In the protocol 2 to define the relationship between load /response an define a threshold level |
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Forced spirometry in primary care: impact of tele-working on the quality of the results and on the interactions between levels of care.. |
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Objetivos: |
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Forced spirometry (FS)is a simple, well standardized and reproducible test when it is performed by technicians in the lung function laboratory. There is, however, a strong worldwide need to generalize the use of FS, with adequate quality standards, in primary care because of its essential role in the management of highly prevalent chronic respiratory disorders, namely asthma and COPD. The current coordinated project between 5 clinical teams (Respiratory Network: Barcelona (2), Bilbao, Cáceres and Asturias as 2 two associated centres) and 1 technological team of the Telemedicine Network (GBT-UPM) has the following aims:
1. To evaluate a tele-collaboration application, between different primary care centres and the corresponding reference hospital, to ensure the quality control of the FE carried out by non-specialized professionals in primary care
2. To evaluate, and make developments, to ensure interoperability between the tele-working application and the existing IT platform.
Following the positive results of a pilot recently done in Barcelona, we designed a controlled study to assess the efficacy, usability and cost of the tele-working application. Each hospital plays the role as reference centre of several primary care centres in the corresponding healthcare sector. The project will also analyze the efficacy of the tele-working application as a tool for continuous professional development addressed to non-specialized personnel. Moreover, the potential of the application as a platform to facilitate interactions across the health care system will also be assessed, as part of the development of integrated care in Spain. |
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Asma actitudes y creencias sobre los corticoides inhalados (ACCRA-1). |
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Objetivos: |
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El incumplimiento terapéutico con los corticoides inhalados es una de las causas más frecuentes que dificultan el control óptimo del asma. La falta de adherencia a los corticoides inhalados puede adoptar formas diferentes y son múltiples los factores implicados en su génesis: la edad, el género, el estado civil, la actividad profesional, el nivel socio-económico, las peculiaridades del tratamiento y, como modulares clave, la personalidad del propio paciente, la posición de éste ante la enfermedad y los medicamentos y su particular percepción de la gravedad del proceso. Estos últimos aspectos constituyen un conjunto de gran importancia porque conocer el perfil de los pacientes incumplidores con el tratamiento esteroideo y aproximarnos a sus creencias, temores y actitudes, es un modo racional de perfilar iniciativas educativas coherentes con la realidad del enfermo.
No existe un marco conceptual definitivo que permita explicar desde esta perspectiva el problema del incumplimiento terapéutico en general y el del incumplimiento con los corticoides inhalados en particular. De todos modos, se han propuesto diversos modelos heurísticos que pretenden incorporar algunos de los planteamientos teóricos señalados al respecto desde la psicología de la salud. Los objetivos del presente estudio son los siguientes:
1) identificar a los asmáticos no cumplidores con el tratamiento esteroideo;
2) rastrear los motivos por los que algunos pacientes no toman de manera adecuada los corticoides inhalados;
3) evaluar las opiniones de los pacientes asmáticos sobre el papel y función de los corticoides inhalados;
4) conocer en cumplidores y no cumplidores cuáles son sus creencias y actitudes frente a los medicamentos, la salud y la enfermedad;
y 5) determinar hasta qué punto las estrategias educativas estándar son capaces de influir sobre el cumplimiento terapéutico. |
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MagMax in COPD: Multicenter Assessment and Follow up of Global Muscle Dysfunction during Acute Exacerbation in patients with Chronic Obstructive Pulmonary Disease. |
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Objetivos: |
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The main AIM of the present study, firstly, is to investigate the potential causes of muscle dysfunction and changes in body composition in patients with acute exacerbation of COPD. Secondly, the study will allow the investigators to create the first Bank of Muscle Tissue from COPD patients. |
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Respiratory rehabilitation (rr) in copd: study of cost-effectiveness. |
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Objetivos: |
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To determine whether a long-term maintenance program after respiratory rehabilitation, in contrast to the usual minimal maintenance therapy, improves the cost-effectiveness through: a.- maintaining long term effects in terms of effort capacity, HRQL, reduced exacerbations and survival. b.- reducing the total cost of care to patients, largely through reduction of exacerbations.
MATERIAL AND METHODS:
multi-center (5 hospitals) prospective randomized controlled study that will include 125 patients with moderate-severe COPD (age <75; FEV1 <55%;) with a 3 years follow-up. All patients will receive an initial in-hospital rehabilitation program which includes: Education, Physiotherapy, lower and upper extremities training and respiratory muscles training. Following completion of this program, patients will undergo concealed randomization to one of two maintenance strategies:
1.-an intensive maintenance program (GR1)
2.- a standard, minimal monitoring program (GR2). On the intensive maintenance program (GR1) the physiotherapist will call once a week as a reminder and the patient will attend the hospital once a week . A physiotherapist will supervise the weekly in-hospital exercise and he/she will check if the patient is properly undergoing the rehabilitation treatment.
OUTCOMES:
1.- Clinical: dyspnea (area of CRQ questionnaire), HRQL (CRQ, SF 36); Effort capacity (6minute Walking Test);
2.- Economical: direct costs (programs); indirect costs (exacerbations, admissions); comparison of GR1 and GR2 costs;
3.- Survival: comparative analysis of survival in GR1 and GR2 in a 1, 2 and 3 years term.
EXPECTED OUTCOMES:
reduction of dyspnea, improvement of HRQL and effort capacity, increase of survival and reduction of health expenditures in GR1 compared to GR2.
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Objetivos: |
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Effects of physical activity on COPD course. |
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Objetivos: |
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1. To describe physical activity levels in COPD patients, using direct and indirect measures.
2. To assess the longitudinal association between usual physical activity and COPD course (respiratory symptoms, exacerbations, lung function, gas exchange, health status, mortality), in a COPD cohort.
3. To assess cross-sectional and longitudinal association between physical activity and: systemic inflammation levels, diet (caloric intake and specific nutrients), and body weight and composition, in COPD patients.
4. To assess cross-sectional and longitudinal association between physical activity and: exercise capacity, and muscle strength, in COPD patients.
5. To validate the \"Yale physical activity questionnaire\" in COPD patients, using direct measures of physical activity (accelerometer). |
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Has muscle training a protective effect against oxidative stress on respiratory muscles of patients with COPD?. |
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Objetivos: |
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MAIN OBJECTIVES:
1:- To evaluate whether a muscle training period specific of the respiratory muscles leads to increased efficiency of the antioxidant systems in both patients with COPD and normal lung function subjects.
2.- To assess whether previous respiratory muscle training improves their resistance to develop oxidative stress after a strenuous exercise.
SECONDARY OBJECTIVES:
3.- To investigate the levels of oxidative stress of the external intercostals muscle in patients with stable COPD and after a strenuous exercise.
4.- To determine the molecular sources of ROS production within the muscle fiber in the external intercostals of COPD patients.
5.- To explore the antioxidant status of the external intercostals muscle of COPD patients, both at the enzymatic and non-enzymatic levels. |
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Integrated care and biopathology of advanced COPD (LINKCARE_COPD). |
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Objetivos: |
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To evaluate the efficacy and costs of an intervention based on the chronic care model proposed by WHO on the disease progress in severe COPD patients.
Analysis of mechanisms of the systemic effects associated with sedentarism and hypoxemia.
Evaluation of biomarkers of tissue hypoxia.
The validation of the extensive use of an information technology platform to support chronic care constitutes an ancillary aim |
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Community-acquired pneumonia in COPD patients admitted in the ICU. |
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Objetivos: |
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1.- To study the epidemiology and etiology of COPD patients with community-acquired pneumonia admitted in ICU.
2.- To determine the risk factors associated with outcome
3.- To evaluate the impacto of empiric initial antibiotic therapy on mortality
4.- To evaluate non-invasive ventilation use and mortality related |
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The lung in transplanted COPD (Red Respira cooperative project, Transepoc). functional, morphometrical, molecular, cellular (including nanotechnology) and experimental studies. |
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Objetivos: |
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The primary objective is to investigate the pulmonary structural basis of the ventilation-perfusion (VA/Q) imbalance in end-stage chronic obstructive pulmonary disease (COPD) undergoing lung transplantation (LT). We will also examine the impact of the oxygen-induced VA/Q changes on pathological features. Measurements of pulmonary vascular involvement will include morphometry of pulmonary muscular arteries as well as reactivity, inflammatory cells and mediators, and vascular endothelial growth factor of the vessels. Further, we will assess the pre-LT cardiopulmonary response to exercise and the effects of LT on a new multidimensional predictor of mortality (BODE index –BI-). In parallel, morphological and molecular measurements in explanted lung tissue will be carried out. The current two subprojects of this application are part of a COOPERATIVE PROJECT within the RED RESPIRA (SCIII-RTIC-03/11) along with three other research groups and one associate group that will assess, separately, innate immunity, genomic expression and patterns of remodelling and components of extracellular matrix in lung tissue specimens and in experimental models. This is a cooperative, multidisciplinary, prospective study in 25-30 patients undergoing LT. Pre-LT measurements will include: a) lung function tests (LFTs); b) respiratory and inert gas exchange and haemodynamic measurements, at rest (breathing room air and 100% oxygen); c) submaximal exercise and 6 min walking distance tests (including BI); and, d) exhaled breath condensate (EBC) analysis and nanotechnology (NT) of peripheral venous neutrophils. Explanted lung specimens will be morphometrically (airways, alveolar spaces and pulmonary vessels) evaluated . Pulmonary vascular involvement, i.e. reactivity, cells and inflammatory mediators, and vascular endothelial growth factor, will be also measured. After LT, LFTs, NT and the BI will be re-assessed. The four other groups will perform different measurements in explanted lung tissue, developing comparative studies in a murine model and in in vitro celullar lines |
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Objetivos: |
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Evaluation of the efficacy and safety of corticosteroids in patients mechanically ventilated because of exacerbation of COPD. A randomized double blind trial.. |
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Objetivos: |
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To evaluate the effect of corticoids on the duration of mechanical ventilation and ICU stay in patients with COPD exacerbated |
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International Registry on Venous Thromboembolism(RIETE). |
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Objetivos: |
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The RIETE Registry was initiated in March 2001 to record current clinical management of VTE within Spanish hospitals. Developed under the guidance of a scientific advisory committee comprising of leading physicians and scientists, the registry is a multicenter, observational study designed to gather and analyze data on treatment patterns and outcomes in patients with symptomatic VTE. In contrast to a randomized controlled trial, there is no imposed experimental intervention: management is determined solely by physicians. Data captured and reported in the registry will therefore reflect real-world approaches and outcomes in the treatment of VTE. |
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An animal model of ventilator associated pneumonia (VAP). Its usefulness in the evaluation of the associated inflammatory response and its modulation by glucocorticoids. |
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Objetivos: |
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In ventilator associated pneumonia (VAP), an excessive associated inflammatory response is related with empiric treatment failure, presence of complications (sepsis) and high mortality. Glucocorticoids (GC) may exert clinical benefits by modulating this inflammatory response, but the intimal pathogenetic mechanisms are unknown. An animal model of “pure” VAP may be very helpful for the proper evaluation of the inflammatory response and its modulation by GC. AIMS: 1) to characterize the local and systemic inflammatory response in a piglet model of VAP due to P. aeruginosa; 2) to determine the effect of GC on clinical severy, intensity of the inflammatory response and histopatological derangement. EXPERIMENTAL DESIGN: Animals: Largewhite-Landrace male piglets. Phase 1: pharmacocinetic profile of Ciprofloxacino and Cefepima. Phase 2: An experimental, randomized, prospective study. Forty-five ventilated animals with P. aeroginosa will be studied. The first group will
be constituted by 15 animals without antibiotic treatment (controls), the second group will receive ciprofloxacino-cefepima (dosage based on phase 1 study). The third group will receive the same antibiotic regim plus metilprednisolone (0.5 mg/Kg/12h/i.v.). MEASUREMENTS: control of hemodinamic and clinical variables, bacteriology, serum CRP and procalcitonine, and citoquine determinations by ELISA (TNF-alfa, IL-6, Il-8), in serum and bronchoalveolar lavage at 12h, 24h, 36h, 48h, 72h and 96h. After the animal sacrifice at 96h of evolution, lung samples for microbiological and histopathological evaluation will be obtained. STUDY VARIABLES: clinical scores (PaO2/FiO2, hemodinámic determinations, lung mechanics), biochemestry parameters, mortality at 96h, microbiológical cultures and histopathological score |
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