Pharmacogenetics of b2-Agonists in Asthma.
20 de febrero de 2018 actualizado por: Kathryn Blake, PharmD, Nemours Children's Clinic
This study will help to find out if having a certain genetic makeup influences how a person with asthma responds to salmeterol, one of the two drugs in Advair(R).
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
Patients are being asked to take part in this research study because they have asthma. This clinical research study is being done to see if an asthmatic's gene make-up (DNA is made up of genes) affects the way they respond to a particular asthma medication called salmeterol. Certain genes make people tall or short. Certain genes give people brown or black hair. Similarly, certain genes may be associated with the way patients respond to asthma medications.
Salmeterol xinafoate (a long acting bronchodilator) and fluticasone propionate (an inhaled corticosteroid) are the medicines contained in Advair Diskus. During this study, patients with asthma will receive fluticasone inhaler (called Flovent) and Advair Diskus. The investigators want to find out if patients with asthma with certain genes respond in different ways to the salmeterol in Advair Diskus. The investigators also want to find out if patients with asthma with certain genes who are treated with salmeterol for two weeks have their airways open up less than usual when they use albuterol.
Tipo de estudio
De observación
Inscripción (Actual)
88
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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Florida
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Jacksonville, Florida, Estados Unidos, 32207
- Nemours Children's Clinic
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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
10 años y mayores (Niño, Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
The study population was Whites and African Americans with specific ADRB2 diplotypes aged 10 years or older with physician diagnosed asthma according to American Thoracic Society criteria for at least 3 months, forced expiratory volume in the first second (FEV1) >= 60% of predicted normal values for age, height, and gender, and a methacholine challenge test provocative concentration (20% fall in FEV1) of <=12]mg/ml.
Descripción
Inclusion Criteria:
- Diplotype: Whites with specific diplotype and African Americans with specific diplotypes.
- Gender: Male or female. Women are eligible if they are not pregnant or lactating. Females subjects of childbearing potential will undergo a urine pregnancy test prior to each methacholine challenge test.
- Age: 10 years and older.
- Asthma Diagnosis: Physician diagnosed asthma according to American Thoracic Society criteria for at least 3 months.
- Asthma Therapy: There is no requirement for previous asthma therapy to be included in this study.
- Asthma Severity: forced expiratory volume in the first second (FEV1) must be >= 60% of predicted normal values for age, height, and gender.
- methacholine challenge test provocative concentration (20% fall in FEV1) of <=12]mg/ml.
Exclusion Criteria:
- History of life-threatening asthma: Any episode of asthma requiring intubation associated with hypercapnia, respiratory arrest, or hypoxic seizures.
- Asthma instability: Hospitalization for asthma within 3 months of Visit 1.
- Concurrent respiratory disease: Any respiratory disease other than asthma.
- Sensitivities: Sensitivities to methacholine, Flovent® MDI, ipratropium bromide, albuterol, or Advair Diskus® that would put the safety of the subject at risk.
- Respiratory Tract Infection: Any sinus, middle ear, oropharyngeal, upper or lower respiratory tract infection that has not resolved at least 2 weeks immediately preceding Visit 1, or for which antibiotic therapy has not been completed at least 2 weeks prior to Visit 1.
- Expected exposure to pollen allergen to which the patient is sensitive (by medical history of symptoms) during the 29 day study period. These patients can be studied when pollen exposure to which they are sensitive will not occur.
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
- Modelos observacionales: Caso cruzado
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
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Whites ADRB2:ARG16ARG
All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol for 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose.
All participants receive ipratropium bromide for symptom rescue therapy.
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Whites ADRB2:GLY16GLY
All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol for 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose.
All participants receive ipratropium bromide for symptom rescue therapy.
|
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African American ADRB2:ARG16ARG
All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol for 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose.
All participants receive ipratropium bromide for symptom rescue therapy.
|
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African American ADRB2:GLY16GLY
All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol for 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose.
All participants receive ipratropium bromide for symptom rescue therapy.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Log10 PC20 to Methacholine After Visit 2
Periodo de tiempo: Visit 2:12 hours after last dose of Flovent
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Visit 2 log10 PC20 after receiving 2 weeks of Flovent
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Visit 2:12 hours after last dose of Flovent
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Log10 PC20 to Methacholine After Visit 3
Periodo de tiempo: Visit 3:12 hours after the last dose of Advair
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Visit 3 Log10 PC20 after receiving 2 weeks of Advair
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Visit 3:12 hours after the last dose of Advair
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Log10 PC20 to Methacholine After Visit 4
Periodo de tiempo: 36 hours after the last dose of Advair
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Visit 4 log10 PC20 to Methacholine after stopping Advair
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36 hours after the last dose of Advair
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Bronchodilator Response to Methacholine (PC20) After Visit 2
Periodo de tiempo: 0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes after nebulization was complete which occurred 12 hours after the last dose of Flovent.
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The area under the curve (AUC) bronchodilator response after Visit 2 methacholine challenge.
2.5mg of albuterol was administered at the time of maximal brochoconstriction once the methacholine PC20 was reached and the change in FEV1 was measured over the next 60 minutes post albuterol administration (bronchodilator response).
FEV1 was measured at the following times: 0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes.
Participants had received Flovent for 2 weeks at Visit 2.
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0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes after nebulization was complete which occurred 12 hours after the last dose of Flovent.
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Bronchodilator Response Following Methacholine Challenge at Visit 3
Periodo de tiempo: 0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes after nebulization was complete which occurred 12 hours after the last dose of Advair
|
The area under the curve (AUC) bronchodilator response after Visit 3 methacholine challenge.
2.5mg of albuterol was administered at the time of maximal brochoconstriction once the methacholine PC20 was reached and the change in FEV1 was measured over the next 60 minutes post albuterol administration (bronchodilator response).
FEV1 was measured at the following times: 0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes.
Participants had received Advair for 2 weeks at Visit 3.
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0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes after nebulization was complete which occurred 12 hours after the last dose of Advair
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Bronchodilator Response Following Methacholine Challenge at Visit 4
Periodo de tiempo: 0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes after nebulization was complete which occurred 36 hours after the last dose of Advair
|
The area under the curve (AUC) bronchodilator response after Visit 4 methacholine challenge.
2.5mg of albuterol was administered at the time of maximal brochoconstriction once the methacholine PC20 was reached and the change in FEV1 was measured over the next 60 minutes post albuterol administration (bronchodilator response).
FEV1 was measured at the following times: 0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes.
Participants had discontinued Advair for 36 hours.
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0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes after nebulization was complete which occurred 36 hours after the last dose of Advair
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Kathryn Blake, Pharm.D., Nemours Children's Clinic
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.
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 septiembre de 2007
Finalización primaria (Actual)
1 de agosto de 2012
Finalización del estudio (Actual)
1 de agosto de 2012
Fechas de registro del estudio
Enviado por primera vez
27 de junio de 2008
Primero enviado que cumplió con los criterios de control de calidad
1 de julio de 2008
Publicado por primera vez (Estimar)
2 de julio de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de febrero de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
20 de febrero de 2018
Última verificación
1 de febrero de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 82211
- K23HL081245 (Subvención/contrato del NIH de EE. UU.)
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