This study will evaluate whether prompt initiation and maintenance of Breztri (a triple therapy) following a severe COPD exacerbation hospitalization, is associated with a lower risk of all-cause readmissions at 90 days post-discharge, compared to receiving any non-triple inhaled therapy.
IKANOS is 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. The interventional arm will be comprised of around 1000 patients for whom Breztri maintenance is prescribed, and the first dose is received prior to hospital discharge (the "index discharge") after a severe COPD exacerbation (the index admission). At the end of the recruitment period of the interventional arm, the external comparator arm will be constructed from real-world data of patients contemporaneous with those in the interventional arm, from the same or similar integrated delivery network as the interventional arm and who are similar in key clinical and demographic characteristics. Patients will be followed-up through their data and call center contact for up to 12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
2 inhalations twice daily administered by oral inhalation, from a metered dose inhaler, over a 12-month follow-up period.
Received any inhaled therapy, excluding triple inhaled maintenance therapy, during index hospitalization and refilled within 30 days before or after discharge from index hospitalization
Proportion of patients with an all-cause readmission
Time frame: 90 days post-index discharge
Number of all-cause readmissions
Time frame: 90 days post-index discharge
Time to first all-cause readmission
Time frame: 1 year post-index discharge
Proportion of patients with all-cause readmissions
Time frame: 30 days and 1 year post-index discharge
number of all-cause readmissions per time period
Time frame: 30 days and 1 year post-index discharge
proportion of patients experiencing COPD moderate/severe exacerbations
Time frame: 30 days, 90 days and 1 year post-index discharge
proportion of patients experiencing COPD severe exacerbations
Time frame: 30 days, 90 days, and 1 year post-index discharge
number of COPD moderate/severe exacerbations per time period
Time frame: 30 days, 90 days, and 1 year post-index discharge
number of COPD severe exacerbations per time period
Time frame: 30 days, 90 days, and 1 year post-index discharge
time to first COPD moderate/severe exacerbations
Time frame: 1 year post-index discharge
time to first COPD severe exacerbations
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Time frame: 1 year post-index discharge
proportion of patients experiencing all-cause mortality
Time frame: 90 days and 1 year post-index discharge
time to all-cause mortality
Time frame: 1 year post-index discharge