Click image to enlargeA Randomized, Double-Blind, Double Dummy, Parallel Group, Multicenter 24 to 52 Week Variable Length Study to Assess the Efficacy and Safety of Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhaler (MDI) Relative to Budesonide and Formoterol Fumarate MDI and Symbicort® Pressurized MDI in Adult and Adolescent Participants with Inadequately Controlled Asthma (LOGOS)
Participant must:
Be at least 12 to 80 years of age inclusive, at the time of signing the ICF.
Have a documented history of at least one asthma exacerbation requiring use of systemic corticosteroids (oral or IV) and any combination thereof for at least 3 consecutive days AND an associated physician visit, hospitalization, or ER visit due to asthma (within 3 days of the corticosteroid use) in the 12 months prior to Visit 1.
Documented reversibility to albuterol, which is defined as a post-albuterol increase in FEV1 of ≥12% and ≥200 mL for participants ≥18 years of age OR a post-albuterol increase of FEV1 of ≥12% for participants 12 to <18 years of age at Visit 2, or at Visit 3 if repeat testing necessary.
Body mass index <40 kg/m2.