Estudio de fase 4, de 52 semanas (análisis primario a las 24 semanas), aleatorizado, estratificado, abierto, con control activo, de grupos paralelos, de efectividad, que compara FF/UMEC/VI con el tratamiento habitual no Ellipta (CSI/LABA) en participantes adultos con asma no controlada

Activo, no reclutaFase 4ClinicalTrials.gov

ID: NCT06372496Tipo: INTERVENTIONALInicio: 16 de abr de 2024Fin estimado: 31 de mar de 2027

Resumen

El objetivo de este estudio es evaluar y comparar la efectividad de furoato de fluticasona/bromuro de umeclidinio/vilanterol trifenatato (FF/UMEC/VI) con corticosteroides inhalados/agonistas beta-2 de acción prolongada (CSI/LABA) en participantes adultos con asma no controlada.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Participants are eligible to be included in the study only if all of the following criteria apply:
Has a diagnosis of asthma as defined by Global Initiative for Asthma (GINA) 2023 guidelines for at least 3 months prior to randomization.
Participants who are either:
Currently untreated
Treated with daily maintenance ICS or ICS/LABA
ACQ-6 score ≥1.5 at randomization.
Participants able to perform technically acceptable and repeatable FEV1 maneuvers (i.e., a minimum of 2 acceptable and 1 repeatable effort) at visit 2 (V2)
Participants must be able to complete the study questionnaires.

Criterios de exclusión

Participants are excluded from the study if any of the following criteria apply:
Recent history of life-threatening asthma
History of \>1 severe exacerbation of asthma within 12 months prior to randomization.
Women of childbearing potential that are not following at least one highly effective method of contraception. This includes women who are pregnant or lactating or are planning on becoming pregnant during the study.
A WOCBP must have a negative pregnancy test ≤7 days prior to randomization.
Exposure to inhaler triple therapy \[ICS + Long-acting muscarinic antagonist (LAMA) + LABA as Single inhaler triple therapy (SITT) or Multiple inhaler triple therapy(MITT)\] and/or any LAMA-containing therapy within 12 months prior to randomization.
Ongoing need for biologic therapy or recent use of a biologic therapy
Participants with the diagnosis of chronic obstructive pulmonary disease, as per Global Initiative for Chronic Obstructive Lung Disease (GOLD 2024) guidelines.
Participants whose current medications include RELVAR ELLIPTA and ARNUITY ELLIPTA are not eligible to enter the study.
Participants who are medically unable to withhold their albuterol/salbutamol for 6 hours prior to spirometry testing
Changes in asthma medication (e.g., maintenance ICS/LABA) within 3 months prior to randomization.
Participants with a history of hypersensitivity to any of the study medications

Intervenciones

drug

Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate

Participants will receive FF/UMEC/VI

drug

Inhaled corticosteroids/long-acting beta-2 agonists

Participants will receive ICS/LABA

Ubicaciones

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, Argentina

GSK Investigational Site

Concepción del Uruguay, Argentina

GSK Investigational Site

Córdoba, Argentina

GSK Investigational Site

Formosa, Argentina

GSK Investigational Site

Luján, Argentina

GSK Investigational Site

Luján de Cuyo, Argentina

GSK Investigational Site

Mar del Plata, Argentina

GSK Investigational Site

Mendoza, Argentina

GSK Investigational Site

Mendoza, Argentina

GSK Investigational Site

Mendoza, Argentina

GSK Investigational Site

Quilmes, Argentina

GSK Investigational Site

Rosario, Argentina

GSK Investigational Site

Rosario, Argentina

GSK Investigational Site

Rosario, Argentina

GSK Investigational Site

San Juan Bautista, Argentina

GSK Investigational Site

San Miguel de Tucumán, Argentina

GSK Investigational Site

Santa Fe, Argentina

Patrocinadores

PrincipalGlaxoSmithKline

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