Asthma bronchial asthma
Conditions
Interventions
patinets randomly assign to study intervention
Sponsors
Lydia Demetrious
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in trough forced expiratory volume in 1 second (FEV1) at Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Achieving >=0.5 point improvement (decrease) from baseline for the ACQ-7 at Week 24 | — |
Countries
Argentina, Autralia, Canada, Japan, South Korea, Taiwan, USA
Contacts
Public ContactTakashi Sato
Syneos Health Japan K.K.
Outcome results
None listed