Study B2C112060: A Study of the Efficacy and Safety of Vilanterol Inhalation Powder in Adults and Adolescents With Persistent Asthma
9 de octubre de 2017 actualizado por: GlaxoSmithKline
A Randomized, Double-blind, Double-dummy, Parallel-group, Placebo Controlled (on Inhaled Corticosteroid Medication), Multicenter Study to Evaluate the Efficacy and Safety of Vilanterol Inhalation Powder (GW642444) and Salmeterol, Compared With Placebo in the Treatment of Persistent Asthma in Adults and Adolescents Uncontrolled on Inhaled Corticosteroids
The objective of this study is to evaluate the efficacy and safety of vilanterol inhalation powder administered once daily in the evening in adolescent and adult subjects 12 years of age and older with persistent asthma over a 12-week treatment period.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Actual)
348
Fase
- Fase 3
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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Bayern
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Gauting, Bayern, Alemania, 82131
- GSK Investigational Site
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Hessen
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Frankfurt, Hessen, Alemania, 60596
- GSK Investigational Site
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Rheinland-Pfalz
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Mainz, Rheinland-Pfalz, Alemania, 55131
- GSK Investigational Site
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Schleswig-Holstein
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Grosshansdorf, Schleswig-Holstein, Alemania, 22927
- GSK Investigational Site
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California
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Huntington Beach, California, Estados Unidos, 92647
- GSK Investigational Site
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Florida
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Orlando, Florida, Estados Unidos, 32822
- GSK Investigational Site
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Tallahassee, Florida, Estados Unidos, 32308
- GSK Investigational Site
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Georgia
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Lawrenceville, Georgia, Estados Unidos, 30046
- GSK Investigational Site
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New Jersey
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Skillman, New Jersey, Estados Unidos, 08558
- GSK Investigational Site
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North Carolina
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Raleigh, North Carolina, Estados Unidos, 27607
- GSK Investigational Site
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45231
- GSK Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73103
- GSK Investigational Site
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South Carolina
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Chester, South Carolina, Estados Unidos, 29706
- GSK Investigational Site
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Clinton, South Carolina, Estados Unidos, 29325
- GSK Investigational Site
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Orangeburg, South Carolina, Estados Unidos, 29118
- GSK Investigational Site
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Lima, Perú, Lima 27
- GSK Investigational Site
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Lima
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Callao, Lima, Perú, Callao 2
- GSK Investigational Site
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Lima 27, Lima, Perú, Lima 27
- GSK Investigational Site
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San Isidro, Lima, Perú, Lima 27
- GSK Investigational Site
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San Miguel, Lima, Perú, Lima 32
- GSK Investigational Site
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Chrzanow, Polonia, 32-500
- GSK Investigational Site
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Krakow, Polonia, 31-024
- GSK Investigational Site
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Krakow, Polonia, 31-455
- GSK Investigational Site
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Krakow, Polonia, 30-901
- GSK Investigational Site
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Lublin, Polonia, 20-552
- GSK Investigational Site
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Dnipropetrovsk, Ucrania, 49074
- GSK Investigational Site
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Dnipropetrovsk, Ucrania, 49027
- GSK Investigational Site
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Donetsk, Ucrania, 83099
- GSK Investigational Site
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Ivano-Frankivsk, Ucrania, 76018
- GSK Investigational Site
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Kharkiv, Ucrania, 61124
- GSK Investigational Site
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Kharkiv, Ucrania, 61037
- GSK Investigational Site
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Kyiv, Ucrania, 03680
- GSK Investigational Site
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Simferopol, Ucrania, 95043
- GSK Investigational Site
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Yalta, Ucrania, 98603
- GSK Investigational Site
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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
12 años y mayores (Niño, Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Outpatient at least 12 years of age
- Both genders; females of childbearing potential must be willing to use birth control method
- Clinical diagnosis of asthma for ≥12 weeks
- Best pre-bronchodilator FEV1 of 40%-90% predicted
- Reversibility of FEV1 of at least 12% and 200mls
- Current asthma therapy that include an inhaled corticosteroid for at least 12 weeks prior to 1st visit
- Ability to use replace current short-acting rescue treatment with albuterol and ability to withhold albuterol use for at least 6 hours prior to study visits
Exclusion Criteria:
- History of life-threatening asthma
- Respiratory infection within last 4 weeks leading to change in asthma management
- Asthma exacerbation within last 3 months
- Concurrent respiratory disease or other disease that would confound study participation or affect subject safety
- Allergies to study drugs, study drugs' excipients, or medications related to study drugs
- Taking another investigational medication or medication prohibited for use during the study.
- Previous participation in a vilanterol (GW642444) 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
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Vilanterol
Vilanterol inhalation powder once daily + Placebo inhalation powder via Diskus twice daily for 12 weeks
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Vilanterol inhalation powder inhaled orally once daily for 12 weeks
Placebo inhalation powder inhaled orally twice daily for 12 weeks
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Comparador activo: Salmeterol
Placebo inhalation powder via NDPI once daily + Salmeterol inhalation powder twice daily for 12 weeks
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Salmeterol inhalation powder inhaled orally twice daily for 12 weeks
Placebo inhalation powder inhaled orally via Novel Dry Powder Inhaler
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Comparador de placebos: Placebo
Placebo inhalation powder via NDPI once daily + Placebo inhalation powder via Diskus twice daily for 12 weeks
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Placebo inhalation powder inhaled orally twice daily for 12 weeks
Placebo inhalation powder inhaled orally via Novel Dry Powder Inhaler
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change From Baseline in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at Week 12
Periodo de tiempo: Baseline and Week 12
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FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second.
The weighted mean is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, and 30 minutes (min) and at 1, 2, 3, 4, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, respectively, at Week 12.
The Baseline value was the Day 1 pre-dose FEV1 measurement.
Change from Baseline is calculated as the weighted mean 0-24 hour FEV1 (Liters) at Week 12 minus the Baseline value.
Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline FEV1, region, sex, age, and treatment.
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Baseline and Week 12
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period
Periodo de tiempo: Baseline and Weeks 1-12
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The time span during which the participants did not have to take any rescue bronchodilator (medication intended to relieve symptoms immediately) was considered to be a rescue-free period.
The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant (including the day of randomization).
Change from Baseline is calculated as the value at Weeks 1-12 minus the value at Baseline.
Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
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Baseline and Weeks 1-12
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Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period
Periodo de tiempo: Baseline and Weeks 1-12
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Participants who were symptom free for 24-hour periods during the12-week treatment period were assessed.
The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant (including the day of randomization).
Change from Baseline is calculated as the value at Weeks 1-12 minus the value at Baseline.
Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
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Baseline and Weeks 1-12
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Change From Baseline in Individual Serial FEV1 Assessments at the End of the 12-week Treatment Period, Including the 12-hour and 24-hour Time Points
Periodo de tiempo: Baseline and Week 12
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FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second.
The individual serial FEV1 is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 3, 5, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, relatively, on Treatment Day 84 (Week 12).
The Baseline value was the Day 1 pre-dose FEV1 measurement.
Change from Baseline was calculated as the value of the individual serial FEV1 taken at Week 12 minus the Baseline value.
Analysis was performed using ANCOVA with covariates of Baseline FEV1, region, sex, age, and treatment.
Analysis was performed separately for each planned time point.
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Baseline and Week 12
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Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) PM (Evening) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period
Periodo de tiempo: Baseline and Weeks 1-12
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PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated.
Trough PEF is the PEF measured approximately 24 hours after the last administration of study drug.
The Baseline value is the average value of the last 7 days of daily PM PEF prior to randomization.
Change from Baseline in trough PM PEF was calculated as the averaged value of all daily PM PEF for Week 1 to Week 12 minus the value at Baseline.
Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
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Baseline and Weeks 1-12
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Change From Baseline in Daily AM (Morning) PEF Averaged Over the 12-week Treatment Period
Periodo de tiempo: Baseline and Weeks 1-12
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PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated.
Trough PEF is the PEF measured approximately 24 hours after the last administration of study drug.
The Baseline value is the average value of the last 7 days of daily AM PEF prior to randomization.
Change from Baseline in trough AM PEF was calculated as the averaged value of all daily AM PEF for Weeks 1 to Week 12 minus the value at Baseline.
Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
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Baseline and Weeks 1-12
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Number of Participants With the Indicated Time to an Increase of >=12% and >=200 Milliliters (mL) Above Baseline in FEV1 on Day 1 and Day 84 (0-2 Hours)
Periodo de tiempo: Day 1 and Week 12
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The number of participants with a >=12% and >=200 mL increase from Baseline in FEV1 (the maximal amount of air that can be forcefully exhaled in one second) was evaluated on Day 1 and Week 12 for the time to a >=12% increase from Baseline (at the 5 minutes (min), 15 min, 30 min, 1hour (hr), and 2 hr nominal time points.
Participants who did not achieve a >=12% and >=200 mL increase from Baseline in FEV1 over this time period were considered censored.
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Day 1 and Week 12
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Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12
Periodo de tiempo: Week 4 and Week 12
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At the end of Week 4 and Week 12, the Global Assessment of Change Questionnaire, which assesses changes in asthma symptoms and rescue medication use, was completed by participants using the following scale: asthma symptom (AS) change: much better, somewhat better, a little better, the same, a little worse, somewhat worse, much worse; rescue medication use (RMU): much less often , somewhat less often , a little less often , the same , a little more often , somewhat more often , much more often.
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Week 4 and Week 12
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 2010
Finalización primaria (Actual)
1 de agosto de 2011
Finalización del estudio (Actual)
26 de agosto de 2011
Fechas de registro del estudio
Enviado por primera vez
15 de julio de 2010
Primero enviado que cumplió con los criterios de control de calidad
12 de agosto de 2010
Publicado por primera vez (Estimar)
13 de agosto de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de noviembre de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
9 de octubre de 2017
Última verificación
1 de octubre de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades de las vías respiratorias
- Enfermedades del sistema inmunológico
- Enfermedades pulmonares
- Hipersensibilidad, Inmediata
- Enfermedades bronquiales
- Enfermedades Pulmonares Obstructivas
- Hipersensibilidad Respiratoria
- Hipersensibilidad
- Asma
- Efectos fisiológicos de las drogas
- Agentes adrenérgicos
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Agentes Autonómicos
- Agentes del sistema nervioso periférico
- Agonistas adrenérgicos
- Agentes broncodilatadores
- Agentes antiasmáticos
- Agentes del sistema respiratorio
- Agonistas del receptor beta-2 adrenérgico
- Agonistas beta adrenérgicos
- Xinafoato de salmeterol
Otros números de identificación del estudio
- 112060
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Datos del estudio/Documentos
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Informe de estudio clínico
Identificador de información: 112060Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Formulario de informe de caso anotado
Identificador de información: 112060Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Formulario de consentimiento informado
Identificador de información: 112060Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Plan de Análisis Estadístico
Identificador de información: 112060Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Conjunto de datos de participantes individuales
Identificador de información: 112060Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Protocolo de estudio
Identificador de información: 112060Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Especificación del conjunto de datos
Identificador de información: 112060Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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. .