- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00060801
Efficacy and Safety of 24 Weeks of Oral Treatment With BIIL 284 BS in Adult and Pediatric Patients
30 de octubre de 2013 actualizado por: Boehringer Ingelheim
A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of 24 Weeks of Oral Treatment With BIIL 284 BS in Adult (75 mg, 150 mg) and Pediatric (75 mg) Cystic Fibrosis Patients
The purpose of this study is to determine the effect of 24 weeks of treatment with BIIL 284 BS compared with placebo on pulmonary function and incidence of pulmonary exacerbation in adult and pediatric cystic fibrosis patients.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción
420
Fase
- Fase 2
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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Arizona
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Tucson, Arizona, Estados Unidos, 85724-5073
- University of Arizona
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72205
- University of Arkansas for Medical Sciences
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California
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Los Angeles, California, Estados Unidos, 90027
- Children's Hospital of Los Angeles
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Palo Alto, California, Estados Unidos, 94304-5786
- Stanford University Medical Center
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San Diego, California, Estados Unidos, 92128-4284
- Children's Hospital & Health Center
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San Francisco, California, Estados Unidos, 94143-0106
- University of California at San Francisco
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Colorado
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Denver, Colorado, Estados Unidos, 80262
- University of Colorado
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Florida
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Orlando, Florida, Estados Unidos, 32801
- The Nemours Children's Clinic
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St. Petersburg, Florida, Estados Unidos, 33701
- Pediatric Pulmonary Associates, PA
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Illinois
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Chicago, Illinois, Estados Unidos, 60614
- Children's Memorial Hospital
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Maywood, Illinois, Estados Unidos, 60153-3333
- Loyola University Medical Center
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202-5225
- Riley Hospital
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Iowa
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Iowa City, Iowa, Estados Unidos, 52242
- University of Iowa Hospitals and Clinics
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40536-0284
- University of Kentucky
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70112
- Tulane University
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, Estados Unidos, 02115
- Children's Hospital
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109-0212
- University of Michigan Health System
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55455
- University of Minnesota
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Missouri
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St. Louis, Missouri, Estados Unidos, 63110
- Washington University-St. Louis Children's Hospital
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68198-5190
- University of Nebraska
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New York
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Albany, New York, Estados Unidos, 12208
- Albany Medical College
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Rochester, New York, Estados Unidos, 14642
- University of Rochester
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599-7220
- University of North Carolina
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Ohio
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Akron, Ohio, Estados Unidos, 44308-1062
- Children's Hospital Medical Center of Akron
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Cincinnati, Ohio, Estados Unidos, 45229-3039
- Children's Hospital Medical Center
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Cleveland, Ohio, Estados Unidos, 44106
- Rainbow Babies & Children's Hospital
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Columbus, Ohio, Estados Unidos, 45205
- Columbus Children's Hospital
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19134
- St. Christopher's Hospital for Children
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Philadelphia, Pennsylvania, Estados Unidos, 19129
- MCP Hospital
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- Children's Hospital of Pittsburgh
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37232-2586
- Vanderbilt Children's Hospital
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Texas
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Dallas, Texas, Estados Unidos, 75235
- Children's Memorial Center of Dallas
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Houston, Texas, Estados Unidos, 77030
- Texas Children's Hospital
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53792
- University of Wisconsin Hospitals & Clinics
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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
6 años y mayores (Niño, Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
INCLUSION CRITERIA:
- Male or female patients >= 6 years pediatric 6-17 years inclusive; adult >= 18 years)
- Body weight >= 20 kg (determined at Visit 1)
- Confirmed diagnosis of CF
- Able to perform acceptable spirometric maneuvers, according to American Thoracic Society standards .
- FEV1 25-85% predicted
- Clinically stable
- The patient or the patient's legally acceptable representative must be able to give informed consent.
- The patient must be able to swallow the BIIL 284 BS tablets whole.
- Patients taking a chronic medication must be willing to continue this therapy for the entire duration of the study.
EXCLUSION CRITERIA:
- Patients with a significant history of allergy/hypersensitivity (including medication allergy) which is deemed relevant to the trial as judged by the Investigator. "Relevance" in this context refers to any increased risk of hypersensitivity reaction to trial medication; there are no specific issues of concern currently identified with respect to use of BIIL 284 BS in allergic patients per se.
- Patients who have participated in another study with an Investigational drug within one month or 6 half-lives (whichever is greater) preceding the screening visit.
- Patients with known relevant substance abuse, including alcohol or drug abuse.
- Female patients who are pregnant or lactating, including females who have a positive serum pregnancy test at screening (pregnancy tests will be performed for all females of child bearing potential).
- Female patients of child bearing potential who are not using a medically approved form of contraception.
- Patients who are unable to comply with food requirements prior to dosing.
- Patients with documented persistent colonization with Burkholderia cepacia.
- Patients chronically using oral corticosteroids or high-dose ibuprofen.
- Patients with hemoglobin < 9.0 g/dL; platelets < 100x10 to the 9th power/L; SGOT (ALT) or SGPT (AST) > 2.5 times the upper limit of normal; creatinine > 1.5 times upper limit normal.
- Clinically significant disease or medical condition other than Cystic Fibrosis or Cystic Fibrosis-related conditions that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data.
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
- Propósito principal: Tratamiento
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Change from baseline in post-bronchodilator forced expiratory volume in one second (FEV1) (percent predicted)
Periodo de tiempo: 28 weeks
|
28 weeks
|
Proportion of patients with at least one pulmonary exacerbation during the treatment period as per definition of Fuchs et al
Periodo de tiempo: 28 weeks
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28 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Change from baseline in post-bronchodilator forced vital capacity (FVC) percent predicted
Periodo de tiempo: 28 weeks
|
28 weeks
|
Change from baseline in post-bronchodilator mean forced expiratory flow during the middle half of the FVC (FEF25-75% ) percent predicted
Periodo de tiempo: 28 weeks
|
28 weeks
|
Change from baseline in post-bronchodilator maximal expiratory flow when 50% of FVC remains in lung (MEF50% )percent predicted
Periodo de tiempo: 28 weeks
|
28 weeks
|
Change from baseline in post-bronchodilator maximal expiratory flow when 25% of FVC remains in lung (MEF25%) percent predicted
Periodo de tiempo: 28 weeks
|
28 weeks
|
Change from baseline in post-bronchodilator inspiratory capacity (IC)
Periodo de tiempo: 28 weeks
|
28 weeks
|
Change from baseline in post-bronchodilator slow vital capacity (SVC)
Periodo de tiempo: 28 weeks
|
28 weeks
|
Change from baseline in pre-bronchodilator FEV1% predicted
Periodo de tiempo: week 12, 24 and 28
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week 12, 24 and 28
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Change from baseline in pre-bronchodilator FVC % predicted
Periodo de tiempo: week 12, 24 and 28
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week 12, 24 and 28
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Change from baseline in pre-bronchodilator FEF25-75% % predicted
Periodo de tiempo: week 12, 24 and 28
|
week 12, 24 and 28
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Change from baseline in pre-bronchodilator MEF50% % predicted
Periodo de tiempo: week 12, 24 and 28
|
week 12, 24 and 28
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Change from baseline in pre-bronchodilator MEF25%% predicted
Periodo de tiempo: week 12, 24 and 28
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week 12, 24 and 28
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Proportion of patients with at least one pulmonary exacerbation during the treatment period as described in Rosenfeld et al.
Periodo de tiempo: 28 weeks
|
28 weeks
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Time to first pulmonary exacerbation
Periodo de tiempo: 28 weeks
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28 weeks
|
Number of pulmonary exacerbations during the treatment period
Periodo de tiempo: 28 weeks
|
28 weeks
|
Proportion of patients with at least 1 hospitalisation for a pulmonary exacerbation during the treatment period
Periodo de tiempo: 28 weeks
|
28 weeks
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Time to first hospitalisation for a pulmonary exacerbation
Periodo de tiempo: 28 weeks
|
28 weeks
|
Number of hospitalisations for a pulmonary exacerbation
Periodo de tiempo: 28 weeks
|
28 weeks
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Number of days in hospital for a pulmonary exacerbation
Periodo de tiempo: 28 weeks
|
28 weeks
|
Proportion of patients with at least one pulmonary exacerbation requiring i.v. antibiotics during the treatment period
Periodo de tiempo: 28 weeks
|
28 weeks
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Time to first course of i.v. antibiotics for a pulmonary exacerbation
Periodo de tiempo: 28 weeks
|
28 weeks
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Number of pulmonary exacerbations requiring i.v. antibiotics during the treatment period
Periodo de tiempo: 28 weeks
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28 weeks
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Number of days of i.v. antibiotic use for pulmonary exacerbations during the treatment period
Periodo de tiempo: 28 weeks
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28 weeks
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Change from baseline in weight
Periodo de tiempo: 28 weeks
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28 weeks
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Change from baseline in height (in pediatrics)
Periodo de tiempo: 28 weeks
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28 weeks
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Change from baseline in weight for age percentiles
Periodo de tiempo: 28 weeks
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28 weeks
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Change from baseline in weight for age percentiles (in pediatrics)
Periodo de tiempo: 28 weeks
|
28 weeks
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Change from baseline in weight expressed as % ideal body weight (IBW)
Periodo de tiempo: 28 weeks
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28 weeks
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Change from baseline in body mass index
Periodo de tiempo: 28 weeks
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28 weeks
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Change from baseline in BMI for age percentiles
Periodo de tiempo: 28 weeks
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28 weeks
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Change from baseline in blood levels of cytokines, chemokines and other inflammatory mediators
Periodo de tiempo: 28 weeks
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28 weeks
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Change in patient's health status as reported by patient
Periodo de tiempo: 28 weeks
|
28 weeks
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Change in patient's health status as reported by physician
Periodo de tiempo: 28 weeks
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28 weeks
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 mayo de 2003
Finalización primaria (Actual)
1 de julio de 2004
Fechas de registro del estudio
Enviado por primera vez
13 de mayo de 2003
Primero enviado que cumplió con los criterios de control de calidad
13 de mayo de 2003
Publicado por primera vez (Estimar)
14 de mayo de 2003
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
31 de octubre de 2013
Última actualización enviada que cumplió con los criterios de control de calidad
30 de octubre de 2013
Última verificación
1 de octubre de 2013
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BI 543.45
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 Fibrosis quística
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Peking Union Medical College HospitalReclutamientoFibrosis Retroperitoneal IdiopáticaPorcelana
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Peking Union Medical College HospitalReclutamiento
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Peking Union Medical College HospitalReclutamientoFibrosis Retroperitoneal IdiopáticaPorcelana
-
San Gerardo HospitalTerminadoFibrosis pulmonar idiopática | Fibrosis cardiaca | Fibrosis ArterialItalia
-
Assistance Publique - Hôpitaux de ParisReclutamientoFibrosis Retroperitoneal IdiopáticaFrancia
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Peking Union Medical College HospitalReclutamientoFibrosis Retroperitoneal IdiopáticaPorcelana
-
Hospital de Clinicas de Porto AlegreDesconocidoFibrosis quística | Exacerbación pulmonar de fibrosis quística | Fibrosis quística en niños | Fibrosis quística con exacerbaciónBrasil
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University of ParmaDesconocidoFibrosis Retroperitoneal Idiopática | Fibrosis retroperitoneal perianeurismática | Periaortitis crónicaItalia
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Olympus Corporation of the AmericasGeisinger ClinicTerminado
-
Johns Hopkins UniversityGuerbetAún no reclutandoFibrosis miocárdicaEstados Unidos
Ensayos clínicos sobre BIIL 283 BS (Amelubent)
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Boehringer IngelheimTerminado
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Boehringer IngelheimTerminadoEnfermedad Pulmonar Obstructiva Crónica
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Boehringer IngelheimTerminado
-
Boehringer IngelheimTerminado
-
Boehringer IngelheimTerminado
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Boehringer IngelheimTerminado
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Boehringer IngelheimTerminado