Pragmatic open - label randomized clinical trial of FF/UMEC/VI vs non-ellipta usual care ICS-LABA for adult participants with uncontrolled asthma.

JRCT ID: jRCT2031240008

Registered date:03/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Asthma
• Date of first enrollment: 31/05/2024
• Target sample size: 1136
• Countries of recruitment: Argentina,Japan,Autralia,Japan,Canada,Japan,South Korea,Japan,Taiwan,Japan,USA,Japan
• Study type: Interventional
• Intervention(s): patinets randomly assign to study intervention

Outcome(s)

• Primary Outcome: Change from baseline in trough forced expiratory volume in 1 second (FEV1) at Week 24
• Secondary Outcome: Achieving >=0.5 point improvement (decrease) from baseline for the ACQ-7 at Week 24

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

1. Age and Sex: Male or female participants who are 18 to 75 years of age at the time of signing the informed consent.
2. Has a diagnosis of asthma as defined by GINA 2022 guidelines for at least 3 months prior to randomization.
3. Severity of symptoms: ACQ-6 score >=1.5 at randomization (V2).
4. Participants who are either:
a. Currently untreated. Untreated is defined as no exposure to ICS-containing therapy within the 3 months prior to randomization.
b. Treated with daily maintenance ICS or ICS/LABA for at least 3 months prior to randomization with no changes to maintenance asthma medications during the 3 months immediately prior to randomization.
5. Lung function testing: Participants able to perform technically acceptable and repeatable FEV1 maneuvers (i.e., a minimum of 3 acceptable and 1 repeatable effort) at V2.

Exclude criteria

1. Recent history of life-threatening asthma
2. History of >1 severe exacerbation of asthma within 12 months prior to randomization.
3. Exposure to inhaler triple therapy (ICS+LAMA+LABA as SITT or MITT) and/or any LAMA-containing therapy within 12 months prior to randomization
4.Ongoing need for biologic therapy or recent use of a biologic therapy
5. Participants whose current medications include RELVAR ELLIPTA and ARNUITY ELLIPTA are not eligible to enter the study

Related Information

• Primary Sponsor: Lydia Demetrious