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Active (not recruiting) Phase 4 NCT06372496

Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma

Phase 4 – monitoring after market approval
Conditions: Asthma

Sponsor: GlaxoSmithKline

trial.available_in: БГ
Overview
The goal of this study is to assess and compare the effectiveness of fluticasone furoate/umeclidinium bromide/vilanterol trifenatate (FF/UMEC/VI) with inhaled corticosteroids/long-acting beta-2 agonists (ICS/LABA) in adult participants with uncontrolled asthma
Who can participate
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1. Has a diagnosis of asthma as defined by Global Initiative for Asthma (GINA) 2023 guidelines for at least 3 months prior to randomization. 2. Participants who are either: * Currently untreated * Treated with daily maintenance ICS or ICS/LABA 3. ACQ-6 score ≥1.5 at randomization. 4. 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) 5. Participants must be able to complete the study questionnaires. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: 1. Recent history of life-threatening asthma 2. History of \>1 severe exacerbation of asthma within 12 months prior to randomization. 3. 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. 4. A WOCBP must have a negative pregnancy test ≤7 days prior to randomization. 5. 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. 6. Ongoing need for biologic therapy or recent use of a biologic therapy 7. Participants with the diagnosis of chronic obstructive pulmonary disease, as per Global Initiative for Chronic Obstructive Lung Disease (GOLD 2024) guidelines. 8. Participants whose current medications include RELVAR ELLIPTA and ARNUITY ELLIPTA are not eligible to enter the study. 9. Participants who are medically unable to withhold their albuterol/salbutamol for 6 hours prior to spirometry testing 10. Changes in asthma medication (e.g., maintenance ICS/LABA) within 3 months prior to randomization. 11. Participants with a history of hypersensitivity to any of the study medications
Locations 8
Argentina (1)
GSK Investigational Site
Buenos Aires
Australia (1)
GSK Investigational Site
Bruce , Australian Capital Territory
Canada (1)
GSK Investigational Site
Windsor , Ontario
China (1)
GSK Investigational Site
Chancheng District , Foshan City
Japan (1)
GSK Investigational Site
Fukuoka
South Korea (1)
GSK Investigational Site
Busan
Taiwan (1)
GSK Investigational Site
Kaohsiung City
United States (1)
GSK Investigational Site
Centreville , Alabama
Technical details
Status
Active (not recruiting)
Phase
Phase 4
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
16.04.2024
Completion date
31.03.2027
Registry ID
NCT06372496
Source
anzctr
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