Pathogenetic Mechanisms of Chronic Obstructive Pulmonary Diseases (CAPTA)
11 de abril de 2012 actualizado por: Raimundas Sakalauskas, Lithuanian University of Health Sciences
Evaluation of Pathogenetic Mechanisms of Chronic Obstructive Pulmonary Diseases
Asthma and chronic obstructive pulmonary disease(COPD) are common diseases, which tend to even increase in many countries.
Both from a clinical and a pathophysiological point of view, this is an important issue.
However, an understanding of the relationship between the complex array of cells and mediators involved in asthma and COPD is not yet fully dissected which makes difficult to find a specific and sensitive panel of biomarkers that can reflect intensity of these pathological processes and can help to predict the individual outcome.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
Objectives:
To evaluate the patterns of pathophysiology and genetic predisposition of COPD and asthma
Tasks:
To evaluate patients that respond to corticosteroids and those who do not
Compare the inflammatory markers:
- of COPD and asthma patients before and after treatment with inhaled glucocorticoids
- of COPD and asthma patients that respond to inhaled glucocorticoids and those who do not
- of nonsmokers and smokers asthma patients
To identify a small set of markers that can be used to predict corticosteroid-treatment response in patients with COPD.
To evaluate epigenetic factors
To compare gene mutation and polymorphism between study groups
To evaluate the relationship between genetic predisposition and pathophysiology, clinical symptoms
To evaluate the relationship between patterns of pathophysiology and clinical symptoms, lung function, quality of life in patients with chronic obstructive pulmonary diseases.
Visit 1 Written informed consent will be obtained
- A full medical, surgical, smoking, labour history. A physical examination will be performed
- Resting SaO2 will be measured, exhaled nitric oxide (FENO)
- Chest X-ray
- Patient will fulfil questionnaires
- Spirometry and bronchodilatation test
- Sputum induction and samples will be performed
Visit 2 • Blood samples for blood clotting test and immunological markers will be taken• Cough inhalation challenge
Visit 3
- Patient will be hospitalized to the Department of Pulmonology and Immunology
- Blood samples for genetic analysis will be taken
- Urinary samples will be taken• Methacholine challenge test Polysomnography
- Bronchoscopy (biopsy and BAL)
- Study drug administration
Visit 4 and 5
- Adverse events, COPD or asthma exacerbation, concomitant medications will be recorded, exhaled nitric oxide (FENO)
- Spirometry
- Patient will fulfil questionnaires
- Cough inhalation challenge
Visit 6
- Patient will fulfil questionnaires
- Spirometry and bronchodilatation test.
- Sputum induction and samples will be performed
Visit 7
• Blood samples for blood clotting test, immunological and genetic analysis will be taken• Cough inhalation challenge
Visit 8
- Patient will be hospitalized to the Department of Pulmonology and Immunology
- Urinary samples will be taken• Methacholine challenge test Polysomnography
- Bronchoscopy (biopsy and BAL)
- Further treatment administration
Tipo de estudio
Intervencionista
Inscripción (Actual)
200
Fase
- No aplica
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
30 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Male or female outpatients aged 40-80 years inclusive.
- An established clinical history of COPD as defined by the GOLD guidelines.
- COPD patients with a baseline (pre-bronchodilator) FEV1 40-80% of predicted normal value; post-bronchodilator FEV1/FVC ratio ≤ 70% predicted.
- COPD patients with a smoking history (current or ex-smoker) of ≥10 pack years or those who have exposure to occupational dust and chemicals
- An established clinical history of asthma defined by the GINA recommendations.
- Subjects with out hypoxemia (all subjects must have an O2 saturation ≥88% on room air).
Control (healthy) subjects with baseline FEV1 >80% of predicted normal value
- A female is eligible to participate this study if she is of non-childbearing potential, or childbearing potential has a negative pregnancy test.
- Patients who did not use inhaled and oral corticosteroids 6 weeks and/or long acting bronchodilators 4 weeks before study.
Exclusion Criteria:
- There is a current respiratory disorder other than COPD and asthma (e.g. lung cancer, sarcoidosis, active tuberculosis etc.)
- Subjects who have had a COPD and asthma exacerbation or respiratory infection in the 4 weeks before Visit 1.
- Subjects with a chest X-ray indicating diagnosis other than COPD or asthma that might interfere with the study.
- Subjects who are unable to stop treatment with inhaled, and oral corticosteroids 6 weeks and/or long acting bronchodilators 4 weeks before study.
- Subjects receiving treatment with cromolyn sodium or nedocromil, oral beta2 - agonists, long acting anticholinergic, leucotriene modifiers
- Subjects who have had lung surgery.
- Subjects with bleeding diathesis.
- Subjects receiving treatment with long-term oxygen therapy.
- Subjects with serious, uncontrolled diseases those are uncontrolled on permitted therapy.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: Budesonide
patients who gave their agreement were randomised to 3 months treatment with either inhaled budesonide (400 µg BD) or placebo
|
inhaled budesonide (400 µg BD) or placebo BD
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from Baseline in inflammatory cell numbers and inflammatory markers at 3 months
Periodo de tiempo: 3 months
|
inflammatory cell numbers and inflammatory markers (cytokines, chemokines, etc.) in different tissue compartments (induced sputum, BAL, bronchial biopsies, blood) will be measured at baseline and 3 months after treatment with budesonide and compared with those from healthy subjects
|
3 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
network analysis of quantitative proteomics of bronchial biopsies
Periodo de tiempo: 3 months
|
pathways analysis will be performed on proteins obtained from bronchial biopsies from asthmatics and COPD patients at baseline and 3 months after treatment
|
3 months
|
|
change of lung function, exNO after 3 months of treatment
Periodo de tiempo: 3 months
|
lung function measurements (spirometry, bronchial responsiveness measurement, capsaicin test) at baseline and 3 months after treatment with budesonide
|
3 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Raimundas Sakalauskas, Prof., Kaunas University of Medicine
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de junio de 2004
Finalización primaria (Actual)
1 de diciembre de 2006
Finalización del estudio (Actual)
1 de junio de 2009
Fechas de registro del estudio
Enviado por primera vez
31 de mayo de 2011
Primero enviado que cumplió con los criterios de control de calidad
20 de junio de 2011
Publicado por primera vez (Estimar)
22 de junio de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
12 de abril de 2012
Última actualización enviada que cumplió con los criterios de control de calidad
11 de abril de 2012
Última verificación
1 de abril de 2012
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Enfermedades Pulmonares Obstructivas
- Enfermedad Pulmonar Obstructiva Crónica
- Efectos fisiológicos de las drogas
- Agentes Autonómicos
- Agentes del sistema nervioso periférico
- Agentes antiinflamatorios
- Glucocorticoides
- Hormonas
- Hormonas, sustitutos hormonales y antagonistas hormonales
- Agentes broncodilatadores
- Agentes antiasmáticos
- Agentes del sistema respiratorio
- Budesonida
Otros números de identificación del estudio
- 48/2004
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
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