Osteoprotegerin (OPG) in Induced Chronic Obstructive Pulmonary Disease (COPD) Sputum
9 de julio de 2019 actualizado por: Imperial College London
Osteoprotegerin (OPG) in Induced Sputum as a Novel Biomarker for COPD
Evaluation of OPG level as disease markers has also been reported.
It has been showed that patients with coronary artery disease had higher serum OPG levels than healthy volunteers.
Moreover, serum OPG levels correlate with the number of stenotic coronary arteries
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Osteoprotegerin (OPG) is a secreted glycoprotein containing 401 amino acids.
It is a member of the tumour necrosis factor (TNF) receptor superfamily.
It was firstly discovered as a protein regulating bone metabolism, inhibiting osteoclastogenesis, consequently, inhibiting bone resorption OPG is detected in lung using Northern blot analysis.
It is likely that OPG would contribute to the pathogenesis of COPD and could be an effective disease marker of the disease
Tipo de estudio
De observación
Inscripción (Actual)
72
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
Sí
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Participants were recruited from the outpatient department of Royal Brompton Hospital and local general practices.
Patients with COPD were diagnosed using the GOLD (Global Initiative for Obstructive Lung Disease) criteria.
25 Patients with COPD who had an exacerbation during the last 2 months prior to the visit were excluded.
Patients with asthma were diagnosed using the GINA (Global Initiative for Asthma) guidelines for asthma.
26 Patients with any other lung diseases were excluded from the study.
This study was reviewed and approved by the Hounslow and Hillingdon Research Ethics Committee.
Written informed consent was obtained from all subjects.
Descripción
Inclusion Criteria:
Healthy non-smokers
- Age <35 years (younger group)
- Aged matched to COPD patients (older group)
- Normal spirometry
- Subjects are able to give informed consent
Healthy smokers
- Age <35 years (younger group)
- Aged matched to COPD patients (older group)
- Normal spirometry
- Subjects are able to give informed consent Stable COPD patients: Stage I-IV according to the GOLD guidelines (3), (9)
- Current and/or ex-smokers with no less than 10 pack-year smoking history
- The subjects are able to give informed consent COPD patients with acute exacerbation: Stage I-IV according to the GOLD guidelines (3), (9)
- Exacerbation of COPD defined as "an event in the natural course of the disease characterised by a change in the patient's baseline dyspnoea, cough and/or sputum beyond day to day variability sufficient to warrant a change in management" (9)
- Current and/or ex-smokers with no less than 10 pack-year smoking history
- The subjects are able to give informed consent Asthma patients
- Patients diagnosed with asthma
- The subjects are able to give informed consent Bronchiectasis patients
- Patients with CT-confirmed bronchiectasis
- The subjects are able to give informed consent Cystic fibrosis patients
- Patients diagnosed with cystic fibrosis
- The subjects are able to give informed consent
Exclusion Criteria:
Healthy non-smokers and smokers
- Upper respiratory infection 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 Stable COPD patients
- Patients who have had an exacerbation which required treatment with oral steroids during the last 2 months prior to the visit
- Upper respiratory infection 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 COPD patients with acute exacerbation
- 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 Asthma
- Upper respiratory infection 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.
Bronchiectasis and cystic fibrosis
- 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.
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
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Healthy volunteers non smoker
18 volunteers
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Used Ultrasonic nebuliser
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Healthy volunteers smoker
15 volunteers
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Used Ultrasonic nebuliser
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Chronic Obstructive Pulmonary Disease COPD
39 volunteers
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Used Ultrasonic nebuliser
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Sputum OPG
Periodo de tiempo: 1 hour
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Sputum OPG as assessed by ELISA at baseline
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1 hour
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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
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 (Actual)
1 de enero de 2008
Finalización primaria (Actual)
1 de marzo de 2010
Finalización del estudio (Actual)
1 de marzo de 2010
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
9 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-Q0407-91
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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
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. .
Ensayos clínicos sobre Induced sputum
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University of LiegeDesconocidoHemorragia | Emergencias | Trauma | CoagulopatíaBélgica