- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00318747
Treatment of Ragweed-Allergic Asthma With an Immunostimulatory Drug
Asthma Immunotherapy With a Ragweed Allergen Immunostimulatory Sequence Conjugate
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Ragweed allergy is a common trigger of asthmatic flare-ups in people with asthma. Individuals with ragweed allergy suffer increased asthma symptoms during the fall allergy season, which generally runs from August to November. These flare-ups can significantly impact an asthma patient's quality of life. AIC is an investigational medicine that combines special DNA sequences that can modify the way the immune system responds. In AIC, these sequences are linked to a piece of the ragweed pollen molecule (known as Amb a 1) that causes hay fever symptoms. Injections of AIC have been shown to change the way the immune system responds to ragweed pollen in both animals and humans in a way that may lead to reduced hay fever symptoms.
In a previous study, AIC was safe and well tolerated, and patients exhibited a decrease in allergy symptoms lasting up to 2 years after treatment on average. This study will evaluate whether short-term use of AIC during the spring can cause long-term immune tolerance to ragweed, reduce asthma symptoms, and decrease use of asthma medications for future allergy seasons.
During the 2007 fall ragweed allergy season, participants will be observed and be asked to keep a diary of their asthma symptoms and medication use. In the spring of 2008, participants will be randomly assigned to receive six weekly doses of either the experimental medicine or placebo. Participants will be observed again for the 2008 fall ragweed season. Another series of three weekly doses of the assigned study treatment will be given in spring 2009, with observation through the 2009 fall ragweed allergy season and possibly the 2010 season. During the observation periods, participants will be asked to track their asthma symptoms and medication use and report this information to study staff. Study visits will be weekly during the spring and biweekly during the ragweed season, with a maximum of 16 visits per year. Allergy and lung tests as well as blood and urine collection will occur at selected study visits; these tests are designed to measure the participants' immune response.
Tipo de estudio
Inscripción
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Maryland
-
Baltimore, Maryland, Estados Unidos, 21224
- Johns Hopkins University
-
-
Ohio
-
Cincinnati, Ohio, Estados Unidos, 452323
- Bernstein Clinical Research Center, University of Cincinnati
-
Columbus, Ohio, Estados Unidos, 43235
- Optimed Research, Ohio State University
-
-
Pennsylvania
-
Hershey, Pennsylvania, Estados Unidos, 71033
- Pennsylvania State University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- History of asthma
- History of asthma medication use during the 2005 fall ragweed season
- Suspected ragweed allergy
- Positive laboratory tests for ragweed allergy
Exclusion Criteria:
- Received immunotherapy for ragweed or other allergens within the 5 years prior to study entry
- Received anti-IgE (omalizumab) within the year prior to study entry
- 3 or more courses of oral corticosteroids for asthma within the year prior to study entry
- Inpatient hospitalization for asthma within the 5 years prior to study entry
- History of respiratory failure or intubation for asthma
- Smoking within the 6 months prior to study entry
- Greater than 5 pack/year history of smoking
- Clinically significant acute or chronic illness
- Chronic immunodeficiency
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
---|
Change in average daily asthma medication use between the 2007 and 2008 ragweed seasons
|
Medidas de resultado secundarias
Medida de resultado |
---|
Effect of AIC on selected secondary clinical outcome measures
|
safety of AIC in this population
|
mechanisms through which AIC may induce tolerance to ragweed
|
Colaboradores e Investigadores
Colaboradores
Investigadores
- Silla de estudio: David Broide, MD, University of California, San Diego
- Investigador principal: Peter Creticos, MD, Johns Hopkins University
Publicaciones y enlaces útiles
Publicaciones Generales
- Simons FE, Shikishima Y, Van Nest G, Eiden JJ, HayGlass KT. Selective immune redirection in humans with ragweed allergy by injecting Amb a 1 linked to immunostimulatory DNA. J Allergy Clin Immunol. 2004 Jun;113(6):1144-51. doi: 10.1016/j.jaci.2004.03.003.
- Tulic MK, Fiset PO, Christodoulopoulos P, Vaillancourt P, Desrosiers M, Lavigne F, Eiden J, Hamid Q. Amb a 1-immunostimulatory oligodeoxynucleotide conjugate immunotherapy decreases the nasal inflammatory response. J Allergy Clin Immunol. 2004 Feb;113(2):235-41. doi: 10.1016/j.jaci.2003.11.001.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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
Palabras clave
Términos MeSH relevantes adicionales
- Infecciones
- Infecciones del Tracto Respiratorio
- Enfermedades de las vías respiratorias
- Enfermedades del sistema inmunológico
- Enfermedades pulmonares
- Hipersensibilidad, Inmediata
- Enfermedades bronquiales
- Enfermedades Otorrinolaringológicas
- Enfermedades Pulmonares Obstructivas
- Hipersensibilidad Respiratoria
- Hipersensibilidad
- Enfermedades de la nariz
- Asma
- Rinitis
- Rinitis Alérgica
- Rinitis, Alérgica, Estacional
Otros números de identificación del estudio
- DAIT ITN031AD
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 Amb a 1-immunostimulatory oligodeoxyribonucleotide conjugate (AIC)
-
Johns Hopkins UniversityTerminado