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

Study identifier:D5980C00034

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Will Be Recruiting

Official Title

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

Medical condition

COPD

Phase

Phase 4

Healthy volunteers

No

Study drug

Budesonide/glycopyrrolate/formoterol fumarate (Breztri Aerosphere) 320 μg/18 μg/9.6 μg administered as two inhalations, twice daily.

Sex

All

Estimated Enrollment

1000

Study type

Interventional

Age

40 Years - 100 Years

Date

Study Start Date: 25 Sept 2023
Estimated Primary Completion Date: 13 Dec 2024
Estimated Study Completion Date: 15 Dec 2025

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2023 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

IQVIA, Premier Inc

Inclusion and exclusion criteria