NCT05970263

IKANOS: Breztri Maintenance Versus Any Non-Triple Inhaled Therapy After Hospitalization for a COPD Exacerbation in the US

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 40 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• COPD

Interventions

Type	Name	Description
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	Received any inhaled therapy, excluding triple inhaled maintenance therapy, during index hospitalization and refilled within 30 days before or after discharge from index hospitalization

Timeline

• Start date: 2024-01-19
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-08-01
• Last updated: 2024-02-01

Regulatory

• FDA-regulated drug study