- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01801657
The Role of Viral Infection in Acute Exacerbations of Non-cystic Fibrosis Bronchiectasis in Adults
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Bronchiectasis is a chronic airway disease characterised by a vicious cycle of persistent bacterial colonization,inflammation and progressive tissue destruction.Patients with bronchiectasis frequently developed acute exacerbations characterised by acute worsening requiring changes in concomitant use of medication,with attendant adverse effects on their morbidity and health-related quality of life. The detailed pathogenesis of exacerbations of bronchiectasis, however, remains poorly understood.
Recent data suggested that airway infection and inflammation are important drivers of exacerbations,therefore the imbalance between chronic bacterial infection and host immune response may result in bronchiectasis exacerbations. Viral infection may be an important factor that leads to this events.It has been established that respiratory viruses are mainly responsible for the exacerbations of other chronic respiratory diseases, i.e. asthma, COPD and cystic fibosis. However, the data regarding prospective studies that sought to investigate the roles of viruses in acute exacerbation of bronchiectasis are lacking. Furthermore,the associations between viruses and bacteria during exacerbation need to be assessed. This study targets at indentifying the frenquency of common viral infections in adults with non-cystic fibrosis bronchiectasis and may shed light on the effects they have on clinical parameters,i.e. the length of exacerbated symptom to recovery,lung function, pulmonary inflammation, bacterial load and quality of life.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Rongchang Chen, MD
- Número de teléfono: 020-83062718
- Correo electrónico: Chenrc@vip.163.com
Copia de seguridad de contactos de estudio
- Nombre: Nanshan Zhong, MD
- Número de teléfono: 020-83062718
- Correo electrónico: nanshan@vip.163.com
Ubicaciones de estudio
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510000
- Reclutamiento
- The First Affiliated Hospital of Guangzhou Medical University
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Contacto:
- Rongchang Chen, MD
- Número de teléfono: 020-83062718
- Correo electrónico: Chenrc@vip.163.com
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Contacto:
- Nanshan Zhong, MD
- Número de teléfono: 020-83062718
- Correo electrónico: nanshan@vip.163.com
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Sub-Investigador:
- Yonghua Gao, PHD
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Sub-Investigador:
- Gang Xu, PHD
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Sub-Investigador:
- Weijie Guan, PHD
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Sub-Investigador:
- Zhiya Lin, PHD
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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:
- Age ≥ 18 years
- HRCT-diagnosed Bronchiectasis
- Capable of providing written informed consent
Exclusion Criteria:
- Patient judged to have poor compliance
- Cystic fibrosis bronchiectasis
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Bronchiectasis,stable
A patient was defined as stable if there was no exacerbation for the previous 4 wk
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Bronchiectasis,exacerbations
Bronchiectasis exacerbations were defined by subjective and persistent(>24 h) deterioration in at least three respiratory symptoms, including cough, dyspnea, hemoptysis, increased sputum purulence or volume, chest pain (with or without fever), radiographic deterioration, systemic disturbances, or changes in chest auscultation
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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The prevalence of respiratory virus infection in adults with bronchiectasis during a pulmonary exacerbation and when clinically stable.
Periodo de tiempo: 1 year
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Respiratory viruses in the nasal swab and sputum will be identified using the polymerase chain reaction(PCR)technique when clinically stable and during exacerbation.The following viruses will be tested for:influenza A,B(including influenza A H1N1),respiratory syncytial virus(RSV),Enterovirus,Parainfluenza 1-4,Rhinovirus,human Coronaviruses(subtypes OC43、229E、HKU1),human metapneumovirus,adenovirus, human bocavirus,chlamydia,mycoplasma.
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1 year
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
The effect of respiratory virus infection on systemic and pulmonary inflammatory markers.
Periodo de tiempo: 1 year
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Systemic and airway inflammatory cytokines including IL-1β、IL-6、IL-8、TNF-a were measured using a commercial multiplex bead-based assay.
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1 year
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The effect of respiratory virus on lung function
Periodo de tiempo: 1 year
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Spirometric indices in the present study is referred to as forced expiratory vilume in 1s(FEV1),forced vital capacity(FVC).Spirometry tests are carried out using a spirometer (COSMED, QUARK PFT, Italy).
All operation procedures meet the joint recommendation by ATS and ERS.
A total of at least 3 (not more than 8) spirometric maneuvers are performed, with the variation between the best two maneuvers of <5% or 200ml in FVC and FEV1.
The maximal values of FVC and FEV1 are reported.
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1 year
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The effect of respiratory virus infection on the bacterial load in bronchiectasis.
Periodo de tiempo: 1 year
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Type of bacterial infection, also referred to as potentially pathogenic organisms, and bacterial load, as expressed in cfu per mililiter
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1 year
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Time to recovery of respective symptom
Periodo de tiempo: 1 year
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The time from exacerbation onset by which a 3-d moving average was equal to or exceeded the baseline value
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1 year
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The effect of respiratory virus on quality of life in patients with bronchiectasis
Periodo de tiempo: 1 year
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Quality of life in patients with bronchiectasis were measured by St.George Respiratory Questionnaire、Leicester Cough Questionnaire and COPD assessment test during exacerbations,and then compared between virus-postive and virus-negative patients
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1 year
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To investigate if upper respiratory tract symptoms are associated with viral infections.
Periodo de tiempo: 1 year
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1 year
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Colaboradores e Investigadores
Investigadores
- Investigador principal: Nanshan Zhong, MD, The First Affiliated Hospital of Guangzhou Medical University
- Investigador principal: Rongchang Chen, MD, The First Affiliated Hospital of Guangzhou Medical University
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2009CB522109
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