Un estudio para comparar la eficacia, seguridad y tolerabilidad de FF/UMEC/VI con FF/VI en jóvenes de 12 a 17 años con asma
Un estudio de préstamo dinámico bayesiano de fase 3, de 24 semanas, aleatorizado, doble ciego, de grupos paralelos que compara la eficacia, la seguridad, la tolerabilidad y la farmacocinética de FF/UMEC/VI con FF/VI en participantes de 12 a 17 años con Asma mal controlada en terapia de mantenimiento estable con ICS/LABA
The primary purpose of this study is to evaluate the effects of Fluticasone Furoate (FF)/ Umeclidinium (UMEC)/ Vilanterol (VI) on lung function compared with FF/VI after 24 weeks of treatment.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Buenos Aires, Argentina, C1425BEN
- GSK Investigational Site
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Buenos Aires, Argentina, C1202
- GSK Investigational Site
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Buenos Aires, Argentina, 1888
- GSK Investigational Site
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Buenos Aires, Argentina, 1122
- GSK Investigational Site
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Buenos Aires, Argentina, C1023AAB
- GSK Investigational Site
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Córdoba, Argentina, X5000DCE
- GSK Investigational Site
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Córdoba, Argentina, X5014AKM
- GSK Investigational Site
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Lanus, Argentina, B1824KAJ
- GSK Investigational Site
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Lobos, Argentina, 7240
- GSK Investigational Site
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Lujan de Cuyo, Argentina, 5509
- GSK Investigational Site
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Mar del Plata, Argentina, 7600
- GSK Investigational Site
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Rosario, Argentina, 2000
- GSK Investigational Site
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Rosario Provincia de Santa FE, Argentina, 2000
- GSK Investigational Site
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San Miguel de Tucumán, Argentina, T4000IHE
- GSK Investigational Site
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Santa Fe, Argentina, 3000
- GSK Investigational Site
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Queensland
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South Brisbane, Queensland, Australia, 4101
- GSK Investigational Site
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South Australia
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North Adelaide, South Australia, Australia, 5006
- GSK Investigational Site
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Western Australia
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Joondalup WA, Western Australia, Australia, 6027
- GSK Investigational Site
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Lo Barnechea, Chile, 7691236
- GSK Investigational Site
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Santiago, Chile, 7630000
- GSK Investigational Site
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Santiago, Chile, 8320000
- GSK Investigational Site
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Cheongju Chungcheongbuk-do, Corea del Sur, 28644
- GSK Investigational Site
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Gwangju, Corea del Sur, 501-757
- GSK Investigational Site
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Seoul, Corea del Sur, 05505
- GSK Investigational Site
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Seoul, Corea del Sur, 03722
- GSK Investigational Site
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Seoul, Corea del Sur, 1757
- GSK Investigational Site
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Seoul, Corea del Sur, 2447
- GSK Investigational Site
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Alabama
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Birmingham, Alabama, Estados Unidos, 35244
- GSK Investigational Site
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Mobile, Alabama, Estados Unidos, 36608
- GSK Investigational Site
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Arizona
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Paradise Valley, Arizona, Estados Unidos, 85253
- GSK Investigational Site
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California
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Bakersfield, California, Estados Unidos, 93301-4205
- GSK Investigational Site
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Huntington Beach, California, Estados Unidos, 92647
- GSK Investigational Site
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Mission Viejo, California, Estados Unidos, 92691
- GSK Investigational Site
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Rolling Hills Estates, California, Estados Unidos, 90274
- GSK Investigational Site
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Colorado
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Colorado Springs, Colorado, Estados Unidos, 80909
- GSK Investigational Site
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Florida
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Aventura, Florida, Estados Unidos, 33180
- GSK Investigational Site
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Miami, Florida, Estados Unidos, 33173
- GSK Investigational Site
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Miami, Florida, Estados Unidos, 33165
- GSK Investigational Site
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Miami, Florida, Estados Unidos, 33174
- GSK Investigational Site
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Georgia
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Savannah, Georgia, Estados Unidos, 31406
- GSK Investigational Site
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Illinois
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Normal, Illinois, Estados Unidos, 61761
- GSK Investigational Site
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Kentucky
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Owensboro, Kentucky, Estados Unidos, 42301
- GSK Investigational Site
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Missouri
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Columbia, Missouri, Estados Unidos, 65203
- GSK Investigational Site
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Montana
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Missoula, Montana, Estados Unidos, 59808
- GSK Investigational Site
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New York
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The Bronx, New York, Estados Unidos, 10461-1119
- GSK Investigational Site
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45229
- GSK Investigational Site
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Cleveland, Ohio, Estados Unidos, 44106
- GSK Investigational Site
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Dayton, Ohio, Estados Unidos, 45404
- GSK Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73120-9350
- GSK Investigational Site
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29420
- GSK Investigational Site
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Texas
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Dallas, Texas, Estados Unidos, 75225-6301
- GSK Investigational Site
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Kerrville, Texas, Estados Unidos, 78028
- GSK Investigational Site
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Plano, Texas, Estados Unidos, 75034
- GSK Investigational Site
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Waco, Texas, Estados Unidos, 76712
- GSK Investigational Site
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Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53226
- GSK Investigational Site
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Ashkelon, Israel, 7830604
- GSK Investigational Site
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Haifa, Israel, 3436212
- GSK Investigational Site
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Haifa, Israel, 3109600
- GSK Investigational Site
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Petah Tikva, Israel, 49202
- GSK Investigational Site
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Guadalajara, México, 44100
- GSK Investigational Site
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Monterrey, México, 64460
- GSK Investigational Site
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San Juan del Río, México, 76800
- GSK Investigational Site
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Upper Hutt
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Ebdentown, Upper Hutt, Nueva Zelanda, 5018
- GSK Investigational Site
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Adana, Turquía (Türkiye), 1173
- GSK Investigational Site
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Antalya, Turquía (Türkiye), 07070
- GSK Investigational Site
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Istanbul, Turquía (Türkiye), 34010
- GSK Investigational Site
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Istanbul, Turquía (Türkiye), 34899
- GSK Investigational Site
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Participant must be 12 to 17 years of age (inclusive), at the time of signing the informed consent/assent.
- Participants who have a diagnosis of asthma as defined by the National Institutes of Health [NIH, 2020] at least 1 year prior to Visit 0.
- Participants who have required daily Inhaled corticosteroids (ICS)/ Long-Acting Beta2-Agonist (LABA) treatment for at least 12 weeks prior to Visit 0 with no changes to maintenance asthma medications during the 6 weeks immediately prior to Visit 0 (including no changes to a stable total ICS dose of >250 to <=500 microgram (mcg)/day fluticasone propionate, or equivalent).
- In the 1 year prior to Visit 1: A documented healthcare contact for acute asthma symptoms; OR A documented temporary change in asthma therapy for acute asthma symptoms, according to a prespecified asthma action plan (or equivalent).
- Participants with inadequately controlled asthma (ACQ-6 score ≥1.5) at Visit 1, despite ICS/LABA maintenance therapy.
- A best pre-bronchodilator FEV1 >40% to <=90% of the predicted normal value and a ≥12% increase in FEV1 with albuterol/salbutamol at Visit 1. Predicted values will be based on the European Respiratory Society (ERS) Global Lung Function Initiative.
Exclusion Criteria:
- Chest X-ray documented pneumonia in the 6 weeks prior to Visit 1.
- Any asthma exacerbation requiring a change in maintenance asthma therapy and/or the use of systemic corticosteroids for at least 3 days in the 6 weeks prior to Visit 1. (Participants requiring a temporary change in asthma therapy (e.g., oral corticosteroids or increased dose of ICS) to treat an exacerbation in the 6 weeks prior to Visit 1 are not explicitly excluded at Visit 1 provided that, at the Investigator's discretion, the participant's condition is stable after they have resumed their pre-exacerbation maintenance asthma therapy (without modification), returned to their baseline asthma status and they are considered appropriate for enrollment into this study of up to 6 months duration)
- History of Life-threatening Asthma
- Participants with current evidence of active pulmonary diseases or abnormalities other than asthma (e.g., pneumonia, active tuberculosis, significant bronchiectasis, etc.).
- Current smokers and users of other inhaled products for recreation with or without nicotine (defined as participants who use cigarettes, e-cigarettes, other/vaping-related devices, cigars or pipe tobacco]) within 12 months prior to Visit 1.
Plan de estudios
¿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: Participantes que reciben FF/UMEC/VI
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FF/UMEC/VI will be administered. FF/UMEC/VI and FF/VI will be administered via ELLIPTA inhaler |
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Comparador activo: Participantes que reciben FF/VI
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FF/UMEC/VI and FF/VI will be administered via ELLIPTA inhaler FF/VI will be administered. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change from baseline in trough forced expiratory volume in 1 second (FEV1) (Liters) at Week 24
Periodo de tiempo: Baseline (Week 0) and Week 24
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FEV1 will be measured using spirometry. |
Baseline (Week 0) and Week 24
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change from Baseline in Asthma Control Questionnaire (7 items) (ACQ-7) (Scores on a scale)
Periodo de tiempo: Baseline (Week 0) and Week 24
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ACQ-7 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation)), a question on rescue use and an additional item relating to lung function which is calculated based on FEV1. A score of less than or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma. |
Baseline (Week 0) and Week 24
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Change from Baseline in Asthma Control Questionnaire (6 items) (ACQ-6) (Scores on a scale)
Periodo de tiempo: Baseline (Week 0) and Week 24
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ACQ-6 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation)) and a question on rescue bronchodilator use. A score of less than or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma. |
Baseline (Week 0) and Week 24
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Change from Baseline in Asthma Control Questionnaire (5 items) (ACQ-5) (Scores on a scale)
Periodo de tiempo: Baseline (Week 0) and Week 24
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ACQ-5 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation). A score of less than or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma. |
Baseline (Week 0) and Week 24
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Number of Participants with a clinically important change from baseline in ACQ-7 Score
Periodo de tiempo: Week 24
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ACQ-7 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation)), a question on rescue use and an additional item relating to lung function which is calculated based on FEV1. A score of less than or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma. A change of 0.5 in score suggests a clinically important change in score. |
Week 24
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Number of Participants with a clinically important change from baseline in ACQ-6 Score
Periodo de tiempo: Week 24
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ACQ-6 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation)) and a question on rescue bronchodilator use. A score of less than or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma. A change of 0.5 in score suggests a clinically important change in score. |
Week 24
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Number of Participants with a clinically important change from baseline in ACQ-5 Score
Periodo de tiempo: Week 24
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ACQ-5 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation). A score of less than or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma. A change of 0.5 in score suggests a clinically important change in score. |
Week 24
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: GSK Clinical Trials, GlaxoSmithKline
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
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
Otros números de identificación del estudio
- 206867
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Marco de tiempo para compartir IPD
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Criterios de acceso compartido de IPD
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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