Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
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
Clareo Health | Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma
