- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02141633
Airway and Pulmonary Vascular Endothelial Function in Healthy Smokers: Effect of Inhaled Glucocorticosteroid Treatment (smoker3)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
With this protocol the Investigators will test the hypotheses that a) there is a correlation between airway and pulmonary vascular endothelial function within the current smoker and non-smoker groups, and b) ICS treatment improves airway and pulmonary vascular endothelial function in the current smoker group.
Fifteen healthy current smokers with a >10 pack-year history of smoking and 15 healthy never-smokers will be enrolled. Males and females between 25 and 75 years of age will be recruited There will be 1-4 visits to the laboratory (one for non-smokers, 4 for smokers). All subjects will have the first visit. Current smokers will have 3 additional visits. Current smokers will be asked not to smoke before coming to the laboratory on the 3 study days. All subjects will be instructed to abstain from ingesting alcoholic beverages, coffee or caffeinated drinks for at least 12 hours the night before each study day. The subjects will also be instructed not to use PDE5 inhibitors for 24 hours before coming to the laboratory. On each study day, the protocol will start at the same time (in the morning).
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Florida
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Miami, Florida, Estados Unidos, 33136
- University of Miami School of Medicine
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Fifteen healthy current smokers with a >10 pack-year history of smoking and 15 healthy never-smokers will be enrolled. Males and females between 25 and 75 years of age will be recruited.
Exclusion Criteria:
- Women of childbearing potential who do not use accepted birth control measures; pregnant and breast feeding women
- Cardiovascular disease and/or use of cardiovascular medications
- Subjects with known beta-adrenergic agonist intolerance
- A physician diagnosis of chronic airway disease (asthma, COPD, bronchiectasis, cystic fibrosis)
- Acute respiratory infection within four weeks prior to the study
- Use of any airway medication
- Abnormal pulmonary function
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: smokers
participants with smoking history ( > 10 pack/year) will be enrolled and perform airway blood flow and echocardiogram before and 15 minutes after albuterol inhalation
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participants will performed echocardiogram before and 15 minutes after inhaled albuterol
participants will performed echocardiogram before and 15 minutes after inhaled albuterol
Otros nombres:
participant will be received a 4-week course of inhaled fluticasone (220 μg fluticasone twice a day administered as a MDI using a spacer)
participant will be received a 4-week course of identically appearing placebo (2 puffs twice a day via spacer).
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Experimental: non-smokers
healthy life-time non smokers will be enrolled and perform airway blood flow and echocardiogram before and 15 minutes after albuterol inhalation
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participants will performed echocardiogram before and 15 minutes after inhaled albuterol
participants will performed echocardiogram before and 15 minutes after inhaled albuterol
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Airway Blood Flow
Periodo de tiempo: before and 15 minutes after albuterol inhalation
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compare inhaled albuterol-induced changes in airway blood flow (ΔQaw) in healthy current smokers and lifetime non-smokers as an index of endothelial function in the airway circulation and to compare the results between smokers and non-smokers
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before and 15 minutes after albuterol inhalation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Echocardiogram
Periodo de tiempo: MPAP before and 15 minutes after albuterol inhalation in smokers vs non-smokers
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to compare inhaled albuterol-induced changes in echocardiogram measuring mean pulmonary artery pressure (MPAP)in healthy current smokers and lifetime non-smokers as an index of endothelial function in the pulmonary circulation and to compare the results between smokers and non-smokers
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MPAP before and 15 minutes after albuterol inhalation in smokers vs non-smokers
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Efectos fisiológicos de las drogas
- Agentes adrenérgicos
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Agentes Autonómicos
- Agentes del sistema nervioso periférico
- Agentes antiinflamatorios
- Agonistas adrenérgicos
- Agentes dermatológicos
- Agentes broncodilatadores
- Agentes antiasmáticos
- Agentes del sistema respiratorio
- Agentes de control reproductivo
- Agentes antialérgicos
- Agonistas del receptor beta-2 adrenérgico
- Agonistas beta adrenérgicos
- Agentes tocolíticos
- Fluticasona
- Xhance
- Albuterol
Otros números de identificación del estudio
- 20120896
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