- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02948153
Mucins and Toll-like Receptors in Asthma (MUCITOLL)
Asthma With Bronchial Hypersecretion: Expression of Mucins and Toll-like Receptors in Sputum and Blood
Descripción general del estudio
Descripción detallada
Asthma with bronchial hypersecretion is a type of asthma poorly studied. Its pathogenesis is not well understood but probably is related to the innate impaired immunity, particularly with "toll-like receptors" (TLR) and secretory mucin (MUC).
Objectives 1) Define the clinical and inflammatory phenotype of asthma with bronchial hypersecretion of mucus. 2) Compare the type of mucin present in induced sputum (IS) of patients with and without bronchial hypersecretion. 3) Determine the expression of TLRs in the IS and in the peripheral blood of asthmatics with and without bronchial hypersecretion.
Method: Cross-sectional study which included 43 asthmatic patients, 19 with and 24 without bronchial hypersecretion. All patients underwent the following: IS, spirometry, fractional exhaled nitric oxide (FeNO), prick test, total IgE and blood albumin. Analysis of mucins (MUC2, MUC5AC, MUC5B and MUC1) was determined by ELISA and expression of TLR2 and TLR4 by flow cytometry. The level of asthma control was determined by the asthma control test questionnaire (ACT) and quality of life was assessed by the MiniAQLQ questionnaire.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Barcelona, España, 08041
- Hospital de la Santa Creu i Sant Pau. Carrer Mas Casanovas 90.
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Non-smokers, asthma diagnosed as per the Global INitiative for Asthma (GINA) criteria on maintenance treatment for asthma, aged 18 to 80 years.
Exclusion Criteria:
- Patients were excluded from the study if they had a respiratory tract infection and/or required the use of oral corticosteroids within 30 days prior to inclusion; if they had a concomitant disease (sarcoidosis, lung cancer, pulmonary tuberculosis, bronchiectasis, nephropathy, rheumatic or liver disease); significant comorbidity that could affect the study results in the physician's judgment; or a cognitive impairment that could limit their comprehension of the subject under study or their ability to participate
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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asthma with bronchial hypersecretion
In a clinical study, participants are often divided into groups.
Group one: they were defined as those who expectorated daily for at least three months for a minimum period of two consecutive years, without attribution to any other cause or disease.
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It is a comprehensive study in a large sample using multiple techniques to assess various aspects of the disease.
All patients underwent the following : Induced Sputum, spirometry, fractional exhaled nitric oxide (FeNO), prick test, total IgE and blood albumin.
Analysis of mucins and TLRs
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asthma without hypersecretion
In a clinical study, participants are often divided into groups.
Group two: We defined asthma as a history of variable respiratory symptoms and evidence of variable expiratory airflow limitation.
|
It is a comprehensive study in a large sample using multiple techniques to assess various aspects of the disease.
All patients underwent the following : Induced Sputum, spirometry, fractional exhaled nitric oxide (FeNO), prick test, total IgE and blood albumin.
Analysis of mucins and TLRs
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Number of asthmatic patients with bronchial hypersecretion
Periodo de tiempo: 18 months
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18 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Number of asthmatic patients with altered expression of TLRs
Periodo de tiempo: 18 months
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18 months
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Number of asthmatic patients with altered expression of Mucins
Periodo de tiempo: 18 months
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18 months
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Colaboradores e Investigadores
Colaboradores
Investigadores
- Investigador principal: Astrid Crespo, MD,PHD, Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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
Otros números de identificación del estudio
- IIBSP-ROF-2011-106
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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. .
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