LCI and Bronchial Inflammation in Patients With BO (FRABO-02)
22 de julio de 2015 actualizado por: Dr. med. Martin Rosewich, Johann Wolfgang Goethe University Hospital
Lung Clearance Index (LCI) and Bronchial Inflammation in Patients With Bronchiolitis Obliterans (BO)
The investigators here compare lung function parameters (RV, RV/TLC and FEF75) with the results of the Lung Clearance index (LCI) .
Further this study evaluates bronchial inflammatory markers in 20 patients with bronchiolitis obliterans at the age of 6 to 28 years compared with an age- and sex-matched control group.
The investigators will perform a pulmonary function test (body plethysmography with DLCO) and compare the results with the LCI.
Further we will measure the fraction of exhaled nitric oxide (FeNO) and draw a blood sample to determine the level of systemic inflammation.
Finally induced sputum is collected and a cell count is performed, and cells and supernatants are analyzed for inflammatory markers.
This study will set baseline markers for future interventional studies.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The purpose of this study is to compare lung function values with the Lung clearance index of 20 Patients with Bronchiolitis obliterans aged between 6 up to 28 years. Further we aim to compare the bronchial Inflammation between the patients and a reference group with similar age conditions to determine possible outcome-parameters for following interventional studies.
The sputum samples will be processed and quantitatively analyzed to get a profile of the cytological composition.
(Sputum and serum samples are analyzed by quantitative real-time polymerase chain reaction (PCR) (qRT-PCR) and by cytometric bead assay (CBA).)
Methods and Work Programme:
- Measurement of nitric oxide in expired air (FeNO)
- Lung function testing with spirometry and body plethysmography
- Lung clearance index (LCI)
- Bronchodilation
- Blood test: blood count, CRP, RAST, serum inflammatory mediators, (genetic markers of the non-specific pulmonary defense system)
- Induced sputum for inflammatory mediators and microbiological investigations
Tipo de estudio
De observación
Inscripción (Actual)
37
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
-
-
Hessen
-
Frankfurt am Main, Hessen, Alemania, 60590
- Children's Hospital, Goethe-University
-
-
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
6 años a 28 años (Niño, Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Patients suffering from Bronchiolitis obliterans and controls
Descripción
Inclusion Criteria:
- informed consent
- between 6 and 28 years of age
Known Bronchiolitis obliterans
- no Bronchiolitis obliterans(depending on the study group)
- Ability to perform lung function tests and inhalation
Exclusion Criteria:
- Acute illness with systemic or bronchial inflammation
- every chronic condition or infection (eg HIV, tuberculosis, malignancy)
- pregnancy
- known alcohol and/ or drug abuse
- Inability to understand the extent and scope of the study
- Participation in another 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 |
|---|---|
|
Grupo de asignaturas
Pacientes que sufren de bronquiolitis obliterante diagnosticada por médicos
|
|
|
Grupo de control
edad y sexo emparejados con el grupo de sujetos
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
LCI compared to RV/TLC%-pred.
Periodo de tiempo: during Visit 1 (single day, single observation)
|
Correlation of these lung function Parameters in patients with BO compared to healthy controls
|
during Visit 1 (single day, single observation)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
change of sputum cell count over time (percentage of neutrophils)
Periodo de tiempo: during Visit 1 (single day, single observation)
|
induced sputum will be analyzed for different cellular components such as alveolar macrophages, neutrophils, lymphocytes and others.
Epithelial cells will be excluded
|
during Visit 1 (single day, single observation)
|
|
Comparison of low CrP
Periodo de tiempo: during Visit 1 (single day, single observation)
|
serum parameter for systemic inflammation
|
during Visit 1 (single day, single observation)
|
|
FVC (%-pred.)
Periodo de tiempo: during Visit 1 (single day, single observation)
|
To compare FVC (%-pred.)of
patients suffering from BO with FVC (%-pred.)of a healthy control group
|
during Visit 1 (single day, single observation)
|
|
FEV1 (%-pred.)
Periodo de tiempo: during Visit 1 (single day, single observation)
|
To compare FEV1 (%-pred.)of
patients suffering from BO withFEV1 (%-pred.)of a healthy control group
|
during Visit 1 (single day, single observation)
|
|
Tiffeneau-Index
Periodo de tiempo: during Visit 1 (single day, single observation)
|
To compare Tiffeneau-Index of patients suffering from BO with Tiffeneau-Index of a healthy control group
|
during Visit 1 (single day, single observation)
|
|
sRtot (%-pred.)
Periodo de tiempo: during Visit 1 (single day, single observation)
|
To compare sRtot (%-pred.) of patients suffering from BO with sRtot (%-pred.) of a healthy control group
|
during Visit 1 (single day, single observation)
|
|
RV/TLC (%-pred.)
Periodo de tiempo: during Visit 1 (single day, single observation)
|
To compare RV/TLC (%-pred.) of patients suffering from BO with RV/TLC (%-pred.) of a healthy control group
|
during Visit 1 (single day, single observation)
|
|
IL-6 (pg/ml)
Periodo de tiempo: during Visit 1 (single day, single observation)
|
comparing IL-6 in Serum of patients with BO with healthy controls
|
during Visit 1 (single day, single observation)
|
|
IL-8 (pg/ml)
Periodo de tiempo: during Visit 1 (single day, single observation)1
|
comparing IL-8 in Serum of patients with BO with healthy controls
|
during Visit 1 (single day, single observation)1
|
|
IL-17 (pg/ml)
Periodo de tiempo: during Visit 1 (single day, single observation)
|
comparing IL-17 in Serum of patients with BO with healthy controls
|
during Visit 1 (single day, single observation)
|
|
IL-6 (mRNA delta-delta-ct)
Periodo de tiempo: during Visit 1 (single day, single observation)
|
compare IL-6 mRNA in Sputum cells of patients with BO with healthy controls
|
during Visit 1 (single day, single observation)
|
|
IL-8 (mRNA delta-delta-ct)
Periodo de tiempo: during Visit 1
|
compare IL-8 mRNA in Sputum cells of patients with BO with healthy controls
|
during Visit 1
|
|
IL-17 (mRNA delta-delta-ct)
Periodo de tiempo: during Visit 1 (single day, single observation)
|
compare IL-17 mRNA in Sputum cells of patients with BO with healthy controls
|
during Visit 1 (single day, single observation)
|
|
Percentage of FOXP3 positive cells in Sputum
Periodo de tiempo: during Visit 1 (single day, single observation)
|
compare percentage of FOXP3 positive cells in Sputum cells of patients with BO with healthy controls
|
during Visit 1 (single day, single observation)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Martin Rosewich, MD, Johann Wolfgang Goethe University Hospital
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.
Enlaces Útiles
- Kurland G, Michelson P. Bronchiolitis obliterans in children. Pediatr Pulmonol. 2005 Mar;39(3):193-208. Review
- Smith KJ, Fan LL. Insights into post-infectious bronchiolitis obliterans in children. Thorax. 2006 Jun;61(6):462-3.
- Pichler M, Herrmann G, Schmidt H, Ahrens P, Zielen S. Persistent adenoviral infection and chronic obstructive bronchitis in children: is there a link? Pediatr Pulmonol. 2001 Nov;32(5):367-71.
- Pichler MN, Reichenbach J, Schmidt H, Herrmann G, Zielen S. Severe adenovirus bronchiolitis in children. Acta Paediatr. 2000 Nov;89(11):1387-9.
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
1 de abril de 2013
Finalización primaria (Actual)
1 de noviembre de 2013
Finalización del estudio (Actual)
1 de diciembre de 2014
Fechas de registro del estudio
Enviado por primera vez
6 de julio de 2015
Primero enviado que cumplió con los criterios de control de calidad
8 de julio de 2015
Publicado por primera vez (Estimar)
13 de julio de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
23 de julio de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
22 de julio de 2015
Última verificación
1 de julio de 2015
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- EC 124/13
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