Genomic/ Proteomic/ Metabonomic Profiling in Chronic Obstructive Pulmonary Disease (COPD)
8 de julio de 2019 actualizado por: Imperial College London
A Non Interventional Study to Asses the Utility of Genomic/ Proteomic/ Metabonomic Profiling Approaches to the Classification and Pathological Basis of Inflammatory Lung Disease in Smokers, and Ex-smokers vs. Non-smokers and Asthmatics
Chronic obstructive pulmonary disease (COPD) is a chronic disease characterized by progressive airflow obstruction, chronic cough and dyspnoea in advanced stages.
We hope to develop a better understanding of lung disease. Information from these studies will only be used for research purposes, to help develop safer and more effective treatments for asthma and COPD.
Descripción general del estudio
Estado
Retirado
Condiciones
Intervención / Tratamiento
Descripción detallada
Techniques such as genomics, proteomics and metabonomics, Technologies that aim to identify and quantify the dynamic set of all small molecules and metabolites present in an organism or a biological sample, offer the prospect of efficiently distinguishing individuals with particular diseases.
The advantages of proteomics and metabonomics is that it can be carried out on a standard preparation of serum, plasma or urine, circumventing the need for specialist preparation of cellular mRNA required for genomics This methodology is based on mass spectrometry (MS), gas chromatography-mass spectrometry (GC-MS), and nuclear magnetic resonance (NMR) to analyze metabolites.
High-performance liquid chromatography (HPLC) may also be applied.
Several peak alignment algorithms have been developed to match the chromatograms before applying pattern recognition.
Based on the pattern recognition, several potential biomarkers may be found and further identified by MS.. Finally, a number of potential biomarkers will be identified for distinguishing asthma and COPD.
Tipo de estudio
De observación
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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London, Reino Unido, SW3 6LY
- National Heart and Lung Institute
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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
35 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
N/A
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
Inclusion Criteria - Healthy non-smokers
- Non-smoking volunteer aged 40 -75 years (age matched to COPD patients)
- Normal spirometry (FEV1/FVC ratio >70% and FEV1>80% predicted)
- Subjects are able to give informed consent Inclusion Criteria-COPD patients (stage 2-3 according to the GOLD guidelines)
- Current and/or ex-smokers with no less than 10 pack-year smoking history aged 40-75 years
- 30% FEV1 < 80% of predicted (the upper value is a postbronchodilator value)
- FEV1/FVC < 70%
- Stable COPD (no chest infection requiring antibiotics and/ or oral steroids in the past 2 months)
- Long-acting beta2-agonists and long-acting antimuscarinic bronchodilators need to be stopped at least 8 hours before the study visit
- The subjects are able to give informed consent
Inclusion Criteria - healthy smokers
- Current smokers aged 40 -75 years (age matched to COPD patients)
- Normal spirometry (normal FEV1/FVC ratio >70% and FEV1>80% predicted)
- Subjects are able to give informed consent
Inclusion Criteria - asthmatics
- Non-smoking asthma patients aged 40 -75 years (age matched to COPD patients)
- Normal spirometry (normal FEV1/FVC ratio >70% and FEV1>80% predicted)
- Subjects are able to give informed consent
Exclusion Criteria:
Exclusion Criteria - Healthy non-smokers
- Chest infection that required treatment with antibiotics within the last 4 weeks
- Subjects who have received research medication within the previous one month
- Subjects unable to give informed consent
- Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study Exclusion Criteria-COPD patients
- Bronchodilator reversibility > 12%
- Chest infection that required treatment with antibiotics within the last 4 weeks
- Subjects who have received research medication within the previous one month
- Subjects unable to give informed consent
- Patients with significant co-morbidities including any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study as judged by the investigator
- Any other respiratory disease, which is considered by the investigator to be clinically significant
Exclusion Criteria - healthy smokers
- Chest infection that required treatment with antibiotics within the last 4 weeks
- Subjects who have received research medication within the previous one month
- Subjects unable to give informed consent
Exclusion Criteria - asthmatics
- Chest infection that required treatment with antibiotics within the last 4 weeks
- Patients with significant co-morbidities as judged by the investigator
- Subjects who have received research medication within the previous one month
- Subjects unable to give informed consent
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
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Sergei A Kharitonov, MD PhD, National Heart and Lung Institute
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 (Anticipado)
1 de enero de 2005
Finalización primaria (Anticipado)
1 de septiembre de 2007
Finalización del estudio (Anticipado)
1 de septiembre de 2007
Fechas de registro del estudio
Enviado por primera vez
4 de abril de 2008
Primero enviado que cumplió con los criterios de control de calidad
9 de abril de 2008
Publicado por primera vez (Estimar)
10 de abril de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de julio de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
8 de julio de 2019
Última verificación
1 de julio de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 05/Q0410/97
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .