IKANOS: A Prospective, Open-Label, Minimally Interventional Hybrid Study in the US Comparing Initiation of Breztri Maintenance Versus Any Non-Triple Inhaled Therapy at Discharge after a Hospitalization for a COPD Exacerbation
Budesonide/glycopyrrolate/formoterol fumarate (Breztri Aerosphere) 320 μg/18 μg/9.6 μg administered as two inhalations, twice daily.
40 Years - 100 Years
Endpoint Classification: -
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Verified 01 Jul 2023 by AstraZeneca
IQVIA, Premier Inc
No locations available
1. Interventional Arm: patients receive : a. First dose of Breztri during hospitalization and discharge with 7-day Breztri inhaler b. Breztri refills to cover 12-month follow-up period, mailed in 90-day supply from a central pharmacy. Emergency resupply is also available if needed.
Drug: Budesonide/glycopyrrolate/formoterol fumarate (Breztri Aerosphere) 320 μg/18 μg/9.6 μg administered as two inhalations, twice daily.
2 inhalations twice daily administered by oral inhalation, from a metered dose inhaler, over a 12-month follow-up period.
|Other: External Comparator - Non-Triple|
2. External Comparator Arm: patient who receive any non-triple inhaled therapy following a hospitalization for severe COPD exacerbation. This arm will be constructed of de-Identified patient.
Other: External Comparator
Received any inhaled therapy, excluding triple inhaled maintenance therapy, during index hospitalization and refilled within 30 days before or after discharge from index hospitalization