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

Korábbi kezelés

• History of >1 severe exacerbation of asthma within 12 months prior to randomization.
• 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 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.

Más betegség

• Recent history of life-threatening asthma
• Participants with the diagnosis of chronic obstructive pulmonary disease, as per Global Initiative for Chronic Obstructive Lung Disease (GOLD 2024) guidelines.
• Participants with a history of hypersensitivity to any of the study medications

Egyéb

• Participants are excluded from the study if any of the following criteria apply:
• 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.

• 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.