Last updated 7 months ago

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

1136 patients around the world

Available in Argentina, United States

GlaxoSmithKline

1136Patients around the world

This study is for people with

Asthma

To 75 Years

All Gender

: Has a diagnosis of asthma as defined by Global Initiative for Asthma (GINA) 2022 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 must be able to complete the study questionnaires.

: 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.

SponsorGlaxoSmithKline

Conditions

Asthma

Requirements

To 75 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06372496